Commercialisation of healthcare in Singapore: overview
A Q&A guide to the commercialisation of healthcare in Singapore.
This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in Singapore. It covers the key requirements for manufacturing, advertising and selling drugs, medical devices, biological products and natural health products.
To compare answers across multiple jurisdictions, visit the commercialisation of healthcare Country Q&A tool.
This Q&A is part of the Commercialisation of Healthcare Global Guide. For a full list of jurisdictional Q&As visit www.practicallaw.com/healthcare-guide.
The key piece of legislation governing Western medicines (also known as therapeutic products) in Singapore is the Health Products Act (Cap 122D).
Medical products are also regulated under various laws in Singapore, including:
The Medicines Act (Cap 176).
The Medicines (Advertisement and Sale) Act (Cap 177).
The Tobacco (Control of Advertisements and Sale) Act (Cap 309).
The Sale of Drugs Act (Cap 282).
The Poisons Act (Cap 234).
Their respective subsidiary legislation.
In addition, there are industry guidelines that are published by the regulatory authorities.
The main regulatory authority having oversight of medical products in Singapore is the Health Sciences Authority (HSA). The HSA was formed on 1 April 2001, and integrated ﬁve highly specialised agencies, namely the Centre for Drug Evaluation, the Institute of Science and Forensic Medicine, the National Pharmaceutical Administration, the Product Regulation Department and the Singapore Blood Transfusion Service.
For more information on the HSA see box: The regulatory authorities.
The HSA relies on spontaneous adverse event reporting by private parties (such as healthcare professionals) for the monitoring of post-marketing therapeutic product safety. Healthcare professionals (for example, doctors, pharmacists and dentists) are encouraged to report suspected adverse events that arise from the use of a therapeutic product, in particular serious and fatal reactions to marketed therapeutic products. This serves as one of the most important ways of monitoring the safety of a therapeutic product throughout its marketed life.
Healthcare products are regulated by various legislation, guidelines and agencies depending on the type of product. Generally, the importation, manufacture and supply of therapeutic products (which include Western medicines and biological products), medical devices and cosmetic products are regulated under the Health Products Act. There are also speciﬁc rules under the Medicines Act regulating the import, supply and use of clinical research materials and the labelling of Chinese proprietary medicines.
Natural health products are regulated by the Health Sciences Authority (HSA) under the Medicines Act and related legislation, unless such products are deemed to be food products, pursuant to a food-health product classiﬁcation tree. Food products are regulated under the Sale of Food Act (Cap 283), which is administered by the Agri-Veterinary Authority of Singapore.
Drugs generally fall under the deﬁnition of "therapeutic products". Under the Health Products Act, therapeutic products generally refer to any substance which is to be used by or in human beings for a therapeutic, preventive, palliative or diagnostic purpose, which includes:
Preventing, diagnosing, monitoring, treating, curing or alleviating any disease.
Investigating, modifying or replacing any physiological process.
Influencing, controlling or preventing conception.
For the purpose of this chapter, the term "therapeutic products" broadly includes drugs.
Local manufacturers of therapeutic products must obtain a manufacturer's licence from the Health Sciences Authority (HSA) (section 12, Health Products Act).
When assessing an application for a manufacturer's licence, the HSA takes into consideration the following factors (regulation 4, Health Products (Therapeutic Products) Regulations 2016):
The applicant’s ability to provide and maintain staff, premises, equipment and facilities as necessary for:
carrying out the stages of manufacture of the therapeutic product; and
the handling and storage of the therapeutic product to prevent the deterioration of that product.
The applicant's ability to conduct all manufacturing operations in such a way as to ensure that the therapeutic product is of the correct identity and conforms with the applicable standards of strength, quality and purity.
A manufacturer's licence can only be granted when the manufacturing facilities have been assessed, audited and found to comply with the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice (GMP) for Medicinal Products.
A manufacturer's licence is valid for one year, or such shorter period as specified in that licence. The HSA can renew the licence for periods of one year, with or without modiﬁcations, on application for renewal. GMP certificates issued by the HSA are normally valid for three years from the date of assessment.
If the preparation contains controlled drugs (that is, substances specified in the First Schedule to the Misuse of Drugs Act), manufacturers must also obtain a controlled drugs manufacturing licence.
The advertising of therapeutic products is governed by the Health Products (Advertisement of Therapeutic Products) Regulations 2016, and is enforced by the HSA. These regulations set out certain requirements and restrictions on the advertising of therapeutic products, including:
The broad categories of matters that are to be excluded in advertising therapeutic products.
Restrictions on promoting therapeutic products for certain specified diseases and conditions.
Prohibition against advertisement of prescription-only medicines.
Requirements for the advertisement of pharmacy-only medicines.
The Singapore Code of Advertising Practice (SCAP), which is a guidance code promulgated by the Advertising Standards Authority of Singapore (a self-regulatory body for the advertising industry under the Consumers Association of Singapore), sets out further guidelines on the advertising of therapeutic products. The Singapore Association of Pharmaceutical Industries (SAPI) also prescribes a Code of Marketing Practices and an OTC Medicine Code of Advertising and Promotion Practices as advertising guidelines for the pharmaceutical industry. The Code of Marketing Practices was last revised in 2016, and reflects the revised Code of Practice of the International Federation of Pharmaceutical Manufacturers Associations 2012. It applies to all SAPI member companies and their agents.
The licensing framework for the registration, manufacture, import and wholesale of therapeutic products in Singapore is activity-based. This means that licensing will be required based on the types of activities the company deals with regarding the therapeutic product.
Product registration. In general, all therapeutic products imported or sold in Singapore must be registered with the Health Products Regulation Group of the HSA, subject to certain prescribed exceptions under regulation 58 of the Health Products (Therapeutic Products) Regulations 2016.
The responsibility of obtaining product registration rests with the company seeking to market the therapeutic product in Singapore. This must be a locally registered company that will be responsible for the quality, safety and efficacy of the product. Therapeutic products must be marketed in accordance with the requirements under the Health Products Act and related subsidiary legislation, including the Health Products (Therapeutic Products) Regulations 2016.
In determining whether to register a therapeutic product, the HSA takes into particular consideration the following factors (regulation 22, Health Products (Therapeutic Products) Regulations 2016):
Whether the overall intended benefits to a user of the therapeutic product outweigh the overall risks associated with the use of the therapeutic product.
Whether, based on the formulation, manufacturing process controls, specifications and shelf life of the therapeutic product, and the stability of the therapeutic product under the recommended storage conditions, the product is suitable for its intended purpose and that any risk associated with its use is minimised.
There are four types of evaluation routes for registering a new therapeutic product:
The full evaluation route applies to any new therapeutic product that has not been approved by any drug regulatory agency at the time of submission of the application to the HSA.
The HSA can impose conditions to the registration of a therapeutic product as it thinks necessary. Product registration is renewable annually, on payment of a retention fee.
Additionally, a person may also need to obtain a Form A Poisons Licence to sell or offer for sale the list of substances specified in the Schedule to the Poisons Act (that is, poisons), unless that person is exempted under this Act.
Importer's licence. Generally, only registered therapeutic products can be imported (section 13(2), Health Products Act), and an importer's licence must be obtained by the person seeking to import therapeutic products. Companies that hold a product registration must hold an importer's licence if they are importing their own registered therapeutic product. This includes the import of a therapeutic product for the purpose of export.
The importer's licence will generally only be issued to local importers who have been authorised by the product registrant to import registered products on their behalf. Importers must demonstrate their compliance with the HSA's Good Distribution Practice (GDP) standard before the HSA can consider granting importer's licences.
Separately, importers that have not been authorised by the product registrant to import therapeutic products must obtain consignment approval from the HSA. The HSA can issue an import licence (on consignment basis) to importers who are not product licence holders or authorised agents. The licence allows the import of a registered medicinal product on a per consignment basis after the importer has satisfied the licensing authority that the product to be imported is in all respects the same as the medicinal product registered in Singapore.
A person must obtain a form A poisons licence to import poisons, unless exempted under the Poisons Act.
A person importing controlled drugs must also obtain a licence to import each consignment of controlled drugs.
The holder of a manufacturer's licence for therapeutic products (see above) can import any health product without holding an importer's licence, if the health product is required for the purpose of carrying out the manufacture of a therapeutic product in accordance with the conditions of the manufacturer's licence.
Wholesaler's licence. The wholesale of therapeutic products requires a wholesaler's licence (section 14, Health Products Act). Wholesale includes the supply of a product:
To a person who obtains it for the purposes of supplying it again to another person.
To a person as a commercial sample in the normal course of a lawful trade.
To a person or an institution concerned with scientific education or research that requires the product for the purpose of education or research.
By export to a party outside Singapore.
The granting of the wholesaler's licence is considered when the company has been audited and found to comply with the HSA's GDP standard. A licensed wholesaler must adhere to the scope of activities approved under its wholesaler's licence. This means that a licensed wholesaler can generally only deal in registered therapeutic products, unless the scope of activity of the wholesaler's licence allows that wholesaler to also deal in unregistered therapeutic products. Additional licences and/or approvals from the HSA may be required for the wholesale of certain types of therapeutic products (for example, for the wholesale of controlled drugs and for the export of codeine cough preparations).
Exceptions to licensing requirements. Unregistered drugs can be manufactured or imported into, or supplied in, Singapore for the purpose of being used in any clinical research by way of administration to a subject in accordance with the protocol for the research (that is, as clinical research material). Notice of import (by the importer) or supply (by the local manufacturer) must be made to the HSA before the import or supply of the clinical research material. For clinical trials regulated by the HSA, this notification is made by the sponsor on behalf of the importer or the local manufacturer. For clinical research that is not regulated by the HSA, this notification is made by the importer or the local manufacturer. Additional approvals may be required for the import of certain types of clinical research materials, for example, those containing psychotropic substances.
Individuals are generally allowed to import into Singapore therapeutic products that do not contain any controlled substances speciﬁed by the HSA, provided that they obtain prior approval from the HSA. They can import quantities not exceeding three months' supply for their own personal use. For prescription therapeutic products, individuals must also produce a letter from their doctor and/or a copy of the prescription verifying the need for the therapeutic products, the dosage taken and the total quantity of the therapeutic products to be imported into Singapore. There are some restrictions on the import of therapeutic products containing certain substances (for example, codeine, dextromethorphan, ephedrine, pseudoephedrine).
Unregistered therapeutic products can also be imported into Singapore on a named patient basis, but special approval must ﬁrst be obtained from the Health Products Regulation Group of the HSA. The application must include details of the product to be imported for use, particulars of the importer, the physician responsible and the patient to be treated.
Generic drugs that are essentially similar to a currently registered therapeutic product in Singapore are subject to a less stringent standard of review before being approved for registration in Singapore. "Essentially similar" is deﬁned as:
Having the same qualitative and quantitative composition in terms of active ingredients.
Having the same pharmaceutical dosage form and clinical indication.
There are two possible evaluation routes to choose from in applying for product registration for a generic drug: the abridged evaluation route and the veriﬁcation evaluation route (that is, there is no need for a full evaluation). Compared to the abridged evaluation and veriﬁcation evaluation for new drug applications, the evaluation for a generic drug registration is generally less onerous.
Regulation 23 of the Health Products (Therapeutic Products) Regulations also requires all applicants to identify any patents in force in respect of any therapeutic product to which the application relates. If the applicant is not the proprietor of any such patent, and has not obtained the consent of the patent proprietor to make the application for therapeutic product registration, the applicant must give notice to the proprietor of the patent that such an application is being made. The proprietor of the patent has 45 days from the date that the notice is served to apply for an order or declaration by the court, the Registrar of Patents or a Deputy Registrar of Patents that the patent has been infringed. If no such action is commenced within 45 days, the Health Sciences Authority (HSA) can register the therapeutic product. If such action has been commenced by the proprietor of the patent, the HSA can register the therapeutic product, without further notice to the proprietor of the patent, at the end of 30 months after the date of commencement of the action.
The Health Sciences Authority (HSA) is the regulatory body responsible for registering therapeutic products and for granting approval for importer's, manufacturer's and wholesaler's licences. It is also responsible for enforcing the relevant rules relating to the advertising of therapeutic products.
For more information on the HSA see box: The regulatory authorities.
The discussion below outlines the evaluation routes available for applications to register new drugs that have been previously approved in other jurisdictions. Less onerous standards apply to applications for generic drugs (see Question 4).
The abridged evaluation route is available for therapeutic products that have been evaluated and approved by at least one foreign drug regulatory agency.
The applicant must provide evidence that all aspects (including the quality and direction(s) for use, dosing regimen(s), indication(s) and intended patient group(s)) of the therapeutic product are the same as those approved by the drug regulatory agency that issued the initial approval.
The following technical documents must also be submitted:
Complete quality documents for both the drug substance and drug product.
A non-clinical overview.
A clinical overview, including:
summaries of clinical efﬁcacy and clinical safety;
synopses of relevant studies; and
a tabular listing of the clinical development programme and study reports of the pivotal studies relevant to the requested indication, dosing and/or patient group (the tables and appendices to the pivotal study reports may be submitted on request by the Health Sciences Authority (HSA)).
Medicinal products with similar indication(s), dosing regimen(s), patient group(s), and/or direction(s) for use are eligible for the veriﬁcation evaluation route if they have been approved by at least two of the HSA's reference drug regulatory agencies (via certain specified routes) and meet certain criteria (see below). One of the two reference drug regulatory agencies must be declared as the "primary reference agency".
The HSA's reference agencies include:
The Australia Therapeutic Goods Administration.
The US Food and Drug Administration.
The European Medicines Agency (via the Centralised Procedure).
The UK Medicines and Healthcare Products Regulatory Agency (via the national procedure, or as the reference member state via the mutual recognition procedure or decentralised procedure).
The eligibility criteria include the following:
The application must be submitted within three years of the approval date by the primary reference agency (which can be chosen by the applicant).
A declaration letter issued by the product owner or applicant must be provided stating that all aspects of the drug product's quality (including, but not limited to, the formulation, manufacturing site(s), release and shelf life specifications and primary packaging) are identical to that currently approved by the chosen primary reference agency. However, a different container closure system type (for example, Alu/Alu blister vs high density polyethylene bottle) may be proposed to meet stability requirements of the Association of Southeast Asian Nations.
The product must not be a biological product.
The product and its intended use have not been rejected, withdrawn or approved through an appeal process, or be pending deferral by any drug regulatory agency for safety or efﬁcacy reasons.
A more stringent assessment of the product due to differences in local disease patterns and/or medical practices is not necessary.
The proposed indication(s), dosing regimen(s), patient group(s) and/or direction(s) for use must be the most stringent among those approved by the reference drug regulatory agencies. If the chosen primary reference agency does not bear the most stringent indication(s), dosing regimen(s), patient group(s) and/or direction(s) of use, the clinical assessment report from the reference drug regulatory agency that does meet these requirements must be submitted. Reports from the public domain are acceptable. The proposed package insert/patient information leaflet must be identical to that approved by that reference drug regulatory agency (with the exception of country-specific information).
Information and documents supporting an application, such as certiﬁcates, approval letters and approved product labels, must be in English and authenticated.
It is possible to buy therapeutic products from other jurisdictions and import them into Singapore, provided that the necessary licences and/or approvals are obtained. See Question 3 for more details.
Manufacturers that produce therapeutic products overseas for export to Singapore are subjected to good manufacturing practice (GMP) conformity assessment. They must periodically provide acceptable evidence that the overseas manufacturing facility conforms to GMP standard (acceptable GMP evidence). If no acceptable GMP evidence is provided, the Health Sciences Authority (HSA) will assess conformity with GMP through on-site audits. To assess GMP conformity, the HSA uses the current Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S) Guide to GMP for Medicinal Products as a standard. Further details about what constitutes acceptable GMP evidence can be found in the HSA guideline on GMP Conformity Assessment of an Overseas Manufacturer.
The HSA generally does not regulate the export of therapeutic products to other jurisdictions. However, companies that manufacture therapeutic products in Singapore for export will have to comply with the terms of the manufacturer's licence (see Question 3, Manufacturing). Manufacturers and dealers of therapeutic products can seek the following certiﬁcations from the HSA to facilitate the export of their products:
Good Distribution Practice certiﬁcation.
Certiﬁcate of a Pharmaceutical Product (CPP) (which can attest to the status of a specific therapeutic product in Singapore, for example, whether or not the product is sold in Singapore, or is limited to export).
However, a company that exports controlled drugs will need a licence to export each consignment of controlled drugs. A company that exports psychotropic substances (that is, substances specified in the Health Products (Therapeutic Products) Regulations 2016) must also obtain separate approvals from the HSA.
The advertisement of therapeutic products is regulated under the Health Products Act and the Health Products (Advertisement of Therapeutic Products) Regulations 2016 (TP Advertisement Regulations). The Health Science Authority (HSA) has also issued an explanatory guidance to the TP Advertisement Regulations, which seeks to clarify the principles of advertisement controls for therapeutic products.
For drugs that require a doctor's prescription: no advertisement or sales promotion is allowed to the general public.
For drugs sold in pharmacies only: advertisements must prominently and legibly display advisory or warning statements as required by the HSA.
For drugs sold over the counter: advertisements must be aligned with the intended uses (indicators) as registered with the HSA.
All therapeutic product advertisements directed at the general public (that is, for non-prescription medicines) must comply with the Health Products Act, which prescribes that advertisements must not be false or misleading.
An advertisement may be false or misleading if it (section 20, Health Products Act):
Falsely describes the health product or gives any false information concerning the health product.
Is likely to create an erroneous impression regarding the formulation, composition, design specification, quality, safety, efficacy or uses of the health product.
Advertisements claiming that the therapeutic product will prevent, alleviate or cure a disease included in a list of diseases and conditions speciﬁed in the Second Schedule to the TP Advertisement Regulations (for example, blindness, cancer, drug addiction and deafness) can only be circulated to specified classes of health professionals (for example, qualified doctors, qualified dentists, registered pharmacists, registered nurses and midwives, and persons undergoing training with a view to becoming any of the above).
Advertisements to the public relating to therapeutic products must, among other things (TP Advertisement Regulations):
Not be likely to lead a consumer of the therapeutic product self-diagnosing or inappropriately treating any serious disease by himself or herself.
Not give the impression that advice from a registered pharmacist or qualified doctor or dentist on the use of the therapeutic product is not necessary.
Not encourage, or be likely to encourage, inappropriate or excessive use of the therapeutic product.
Not compare or contrast the therapeutic product with any named therapeutic product or a brand of such product.
Not claim or suggest that the therapeutic product is not accompanied by any side effects.
Not be likely to give rise to unwarranted or unrealistic expectations of the effectiveness of the therapeutic product.
Not be directed, or contain any material that is directed, principally at any person below the age of 14 years.
In addition, advertisements to the public relating to therapeutic products must comply with the Singapore Code of Advertising Practice (SCAP).
The SCAP prescribes that advertisements of therapeutic products must not:
Claim or imply the cure of any ailment, illness or disease.
Offer to diagnose, advise, prescribe or treat any ailment, illness or disease.
Claim to provide rejuvenation, or to prevent, retard or reverse the physiological changes and degenerative conditions brought about by, or associated with, increasing age.
Cause the advertisement audience unwanted anxiety lest they are suffering from any disease or condition of ill health, or falsely suggest that any product is necessary for the maintenance of health or the retention of physical or mental capacities.
Offer any product for any condition that requires the attention of a registered medical or other qualiﬁed practitioner.
Encourage the indiscriminate, unnecessary or excessive use of health or medicinal products.
Make exaggerated claims.
Contain any offer to refund money to dissatisﬁed users.
Rest on claims that a product does not contain a given ingredient that is in common use in competitive products in any way that may give the impression that the ingredient is generally unsafe or harmful.
A medical device includes any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the speciﬁc purposes of:
Diagnosis, prevention, monitoring, treatment or alleviation of any disease.
Diagnosis, monitoring, treatment, alleviation of or compensation for an injury.
Investigation, replacement, modiﬁcation or support of the anatomy or of a physiological process.
Supporting or sustaining life.
Control of conception.
Disinfection of medical devices.
Providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body.
In addition, to fall within the definition of medical device, a device must not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but can be assisted in its intended function by such means.
The Health Sciences Authority (HSA) generally classiﬁes medical devices into four risk classes:
Class A: low risk devices (for example, wheelchairs and tongue depressors).
Class B: low to moderate risk devices (for example, hypodermic needles and suction equipment).
Class C: moderate to high risk devices (for example, ventilators and bone fixation plates).
Class D: high risk devices (for example, heart valves and implantable defibrillators).
The HSA classifies in vitro diagnostic medical devices into the following four separate risk classes:
Class A (IVD): low individual risk and low public health risk devices (for example, clinical chemistry analyser and prepared selective culture media).
Class B (IVD): moderate individual risk and/or low public health risk devices (for example, pregnancy self-testing, anti-nuclear antibody tests and urine test strips).
Class C (IVD): high individual risk and/or moderate public health risk devices (for example, blood glucose self-testing, human leukocyte antigen (HLA) typing tests, prostate-specific antigen (PSA) screening tests and rubella tests).
Class D (IVD): high individual risk and high public health risk devices (for example, HIV blood donor screening and HIV diagnostic tests).
Medical devices with lower risk classifications are generally evaluated by the HSA for registration on the Singapore Medical Device Register within a shorter period of time. The evaluation fees are also lower, and less risky medical devices may also enjoy greater abridgment in the evaluation process (for example, class B medical devices can opt for the immediate class B registration evaluation route if they satisfy certain conditions).
Companies involved in the manufacture, import or wholesale of medical devices must obtain the following licences:
Manufacturer's licence. This is required for any company that manufactures medical devices in Singapore.
Importer's licence. This is required for any company that imports medical devices into Singapore.
Wholesaler's licence. This is required for any company that supplies medical devices by wholesale (which includes export) in Singapore. However, a licensed manufacturer can supply by wholesale the medical devices that it manufactures without having to obtain a wholesaler's licence.
All licences above are valid for 12 months from the date of approval. Licences that are not renewed on time will expire and become invalid.
Generally, a permit is not required to advertise medical devices. However, the advertising of medical devices is regulated by Part V of the Health Products Act and its subsidiary legislation, particularly the Health Products (Medical Devices) Regulations 2010. Section 19 of the Health Products Act prohibits anyone from:
Advertising as a health product a product that is not a health product.
Advertising a registered health product in such a way as to represent it as being usable for any purpose other than that for which it has been registered.
Section 20 of the Health Products Act prohibits false or misleading advertisements (for example, an advertisement that falsely describes the health product, gives any false information, or creates an erroneous impression regarding its formulation, composition, quality, safety, efficacy and so on). Advertisements of medical devices must not contain any statement that expressly or implicitly suggests that the use of the medical device is promoted or endorsed by the HSA (regulation 19, Health Products (Medical Devices) Regulations 2010). Advertisements for medical devices that are intended for direct delivery to the general public or for direct use by the general public must not contain any statement concerning the intended use and efﬁcacy of the medical device unless such statement has been veriﬁed by objective evidence and such objective evidence has been furnished to the HSA at the time of application to register the medical device.
See Question 13 for further details on restrictions applying to advertisements directed to the general public.
Contravention of any of the above provisions is an offence for which an offender may be liable for a ﬁne of up to S$20,000 or to imprisonment of up to 12 months, or both.
The HSA's Guidance on Medical Devices Advertisements and Sales Promotions also provides that advertisements must, among others:
Truthfully state the nature, quality and properties of the medical device and not mislead in any way by ambiguity, exaggeration, omission or otherwise.
Make only substantiated claims (for example, the supporting literature should come from established sources).
Not inaccurately state recommendations relating to the use of medical devices in moderate terms.
Not contain comparisons with other medical devices or related products unless these are scientiﬁcally proven.
Not directly or indirectly encourage indiscriminate use of these medical devices.
Comply with the Singapore Code of Advertising Practice (SCAP) (see Question 8 for a list of SCAP provisions).
Under the Health Products Act and Health Products (Medical Devices) Regulations, all medical devices must be registered with the HSA on the Singapore Medical Device Register before they can be supplied on the Singapore market.
However, there are several exceptions to this registration requirement, specifically for:
Class A medical devices supplied in a non-sterile state.
Medical devices meant for use in clinical research.
Custom-made medical devices.
Medical devices placed on the transition list (that is, products that are still undergoing evaluation by the HSA before being registered on the Singapore Medical Device Register).
Medical devices cleared for import and supply via one of the authorisation routes specified below.
Licensed importers can seek special authorisation for the import and/or supply of unregistered medical devices on the following bases:
Supply by a qualified practitioner for use on their patient. This route is available to licensed qualified practitioners to import and supply unregistered medical devices for use on their patient(s).
Supply on request of facilities licensed under the Private Hospitals and Medical Clinics Act (PHMC Act) (Cap 248). This is to import and supply an unregistered medical device to a clinical laboratory, medical clinic or private hospital licensed under the PHMC Act for their patients.
Export of unregistered medical devices. This is to import unregistered medical devices for the purposes of export or re-export only.
Supply for non-clinical purpose. This is to import and/or supply unregistered medical devices for non-clinical purposes, which refers to any form of use other than use on, or administration to, humans (for example, use as training equipment).
Import on consignment basis (consignment unregistered route). This route can be used to seek authorisation to import a single consignment of low-utilisation unregistered medical devices under an entity's importer's licence. This route does not include an authorisation to supply, which must be obtained on a separate basis.
Supply of refurbished medical devices. This is to import an unregistered medical device that has been previously exported for the purposes of refurbishment and is being returned to the original PHMC licensed facility that owns the medical device.
Additionally, dealers who are not authorised by the registrant of a medical device can seek authorisation from the HSA for the import of the registered medical device, under the authorisation route for import on consignment basis (consignment registered route). Only licensed importers are allowed to submit the application, and to import the registered medical device. Once approval is obtained, supply of the medical device can be performed by licensed wholesalers.
The Health Sciences Authority (HSA) is the regulatory body that enforces the Health Products Act and Health Products (Medical Devices) Regulations and regulates the manufacture, import, wholesale, advertising and sale of medical devices.
For more information on the HSA see box: The regulatory authorities.
In addition to the full evaluation route, there are less rigorous evaluation routes for registration of medical devices that have already been approved in other jurisdictions. Different criteria apply to each evaluation route, as follows:
Immediate registration evaluation route. This route is available for class B medical devices if the following conditions are met:
the device has been approved by at least two of the Health Sciences Authority's (HSA's) independent reference regulatory agencies for intended use that is identical to that submitted for registration in Singapore;
the medical device has been marketed for at least three years in two of the independent reference regulatory agencies' jurisdictions;
no safety issues have been globally associated with the use of the medical device when used as intended by the product owner in the last three years (that is, no reported deaths, no reported serious deterioration in the state of health of any person, no open field safety corrective actions (including recalls) at the point of application); and
there has been no rejection/withdrawal of the medical device by/from any reference regulatory agency/that foreign jurisdiction(s) or the HSA/Singapore due to quality, performance/efficacy or safety issues.
Expedited registration evaluation route. This route is available for class B and C medical devices if the following conditions are met:
the medical device has obtained approval from at least one of the HSA's independent reference regulatory agencies for a labelled use identical to that intended for marketing in Singapore;
the medical device has been marketed for at least three years in the above independent reference regulatory agency's jurisdiction; and
no safety issues have been globally associated with the use of the medical device when used as intended by the product owner in the last three years (that is, no reported deaths, no reported serious deterioration in the state of health of any person, no open field safety corrective actions (including recalls) at the point of application).
Alternatively, this route is available for class B, C and D medical devices if the medical devices have obtained approvals from at least two of the HSA's independent reference regulatory agencies for a labelled use identical to that intended for marketing in Singapore.
Abridged evaluation route. This route is available for class B, C and D medical devices that have obtained the approval of at least one of the HSA's reference regulatory agencies for a labelled use identical to that intended for marketing in Singapore.
Full evaluation route. This route applies to class B, C and D medical devices that have not obtained any prior approval from any of the HSA's reference regulatory agencies at the point of application.
Importers must first obtain an importer's licence before importing medical devices into Singapore. Importers must also ensure that the imported medical devices are registered with the Health Sciences Authority (HSA), unless one of the exceptions to the registration requirement applies (see Question 9, Sale). Medical devices can be exported to other jurisdictions from Singapore, but the exporter must have a wholesaler's licence.
The above licences are valid for 12 months from the date of approval. Licensees must submit a licence renewal application to the HSA for each licence held, to ensure that their licences remain valid for the duration of their activities.
Medical devices can generally be advertised to the general public, except for a few types of advertisements. Advertisements for "professional use only" medical devices, can only be distributed to qualified practitioners, or contained in a publication intended for circulation mainly among such practitioners.
Under regulation 22 of the Health Products (Medical Devices) Regulations 2010), advertisements cannot expressly or implicitly claim, indicate or suggest that the medical device will prevent, alleviate or cure any disease or condition specified in the Second Schedule to the Health Products (Medical Devices) Regulations 2010 (for example, blindness, cancer, drug addiction, deafness, and so on), unless the advertisement is distributed only to, or is contained in a publication intended for circulation mainly among:
Persons undergoing training with a view of becoming qualified or registered as one of the above.
Advertisements to the general public must also comply with the requirements set out in Question 9, Advertising.
The manufacture of biological products is regulated in the same manner as for therapeutic products in general (see Question 3, Manufacturing).
The advertising of biological products is regulated in the same manner as for therapeutic products in general (see Question 3, Advertising).
The sale of biological products is generally regulated in the same way as the sale of therapeutic products. All biological products imported or sold in Singapore must therefore be registered with the Health Sciences Authority (HSA), and the same procedures described in Question 3 will apply.
Additionally, the HSA's Guidance on Registration of Biosimilar Products introduces the concept of similar biological therapeutic products (that is, biosimilar products), outlines the basic principles to be applied to biosimilar products and sets out the applicable procedures for registering those products.
The Health Sciences Authority (HSA) is the regulatory body responsible for granting approval for the import, manufacture, wholesale dealing and registration of biological therapeutic products in Singapore. It is also responsible for enforcing the relevant rules relating to the advertising of biological therapeutic products.
For more information on the HSA see box: The regulatory authorities.
The relevant evaluation procedure for the registration of biological products is the abridged evaluation route. See Question 6 for more details on the abridged evaluation route.
The import and export of biological products are regulated in the same manner as for therapeutic products in general (see Question 7).
Natural health products
Natural health products are regulated by the Health Sciences Authority (HSA) under the Medicines Act and related legislation, unless those products are deemed to be food products under a food-health product classiﬁcation tree. Food products are regulated under the Sale of Foods Act, which is administered by the Agri-Veterinary Authority of Singapore.
This Q&A subdivides natural health products broadly into three groups:
Chinese proprietary medicines, as deﬁned in the Medicines (Traditional Medicines, Homoeopathic Medicines and other Substances) (Exemption) Order (Exemption Order).
Alternative medicines, which consist of traditional medicines and homeopathic medicines as deﬁned in the Exemption Order.
Health supplements, which are deﬁned under the HSA Health Supplements Guidelines as products that are used to supplement a diet, with beneﬁts beyond those of normal nutrients, and/or to support or maintain the healthy functions of the human body.
Chinese proprietary medicines
Persons intending to import, distribute as a wholesaler, manufacture or assemble Chinese proprietary medicines in Singapore must first obtain an import licence, a wholesale dealer's licence, a manufacturer's licence or an assembler's licence respectively from the Health Sciences Authority (HSA). As part of the licence application process, the applicant must also obtain product listing approvals from the HSA for the Chinese proprietary medicines that it deals in.
In contrast, under section 2A of the Exemption Order, persons who sell, supply or export Chinese proprietary medicines, or procure Chinese proprietary medicines for sale, supply or export, are exempted from licensing requirements. Persons who procure the manufacture or assembly of Chinese proprietary medicines for sale, supply or export are also exempted.
Although there is no licensing regime in place for the sale and supply of Chinese proprietary medicines, sections 3 to 5 of the Medicines (Prohibition of Sale and Supply) Order (Prohibition of Sale Order) provides certain minimum standards that Chinese proprietary medicines must meet before they can be sold, supplied or imported into Singapore. For example, Chinese proprietary medicines cannot contain amounts in excess of the following toxic heavy metals:
Arsenic (five parts per million (ppm)).
Copper (150 ppm).
Lead (20 ppm).
Mercury (0.5 ppm).
The Prohibition of Sale Order also specifies limits for various microbes that can be found in Chinese proprietary medicines. Chinese proprietary medicines that contain any poisons will not be permitted for sale, supply or import, unless those items are naturally present in the ingredients of the medicines, and fall within the exceptions set out in the First and Second Schedule to the Prohibition of Sale Order. Additionally, any Chinese proprietary medicines that contains amygdalin, pangamic acid, danthron, suprofen and rhodamine B cannot be sold or imported (Sale of Drugs (Prohibited Drugs) (Consolidation) Regulations; Sale of Drugs (Prohibited Substance–Rhodamine B) Regulations). Chinese proprietary medicines must not contain any synthetic drugs or any other substances not stated on their label. Finally, Chinese proprietary medicines containing animal parts are subject to the Transmissible Spongiform Encephalopathy (TSE) guidelines issued by the HSA to minimise the risk of TSE contamination.
For every consignment imported, importers of Chinese proprietary medicines must submit documents to the HSA showing the absence of western drugs, and the test results of toxic heavy metals and microbial contents.
Chinese proprietary medicines are subject to the advertising restrictions as set out in the Medicines Act and the Medicines (Advertisement and Sale) Act. For example, a permit from the HSA is required for all advertisements or sales promotions for medicinal products directed at the public.
Medicinal product advertisements directed at the general public must not be false or misleading. An advertisement may be false or misleading if it (section 50, Medicines Act):
Falsely describes the medicinal products to which it relates.
Is likely to mislead as to the nature and quality of medicinal products of that description, or as to their uses or effects.
Advertisements claiming that the medicinal product will prevent, alleviate or cure a list of diseases and conditions speciﬁed in the First Schedule to the Medicines Act (for example, blindness, cancer, drug addiction and deafness) can only be circulated to doctors, dentists, veterinary surgeons, pharmacists, nurses and midwives, or persons undergoing training with a view to becoming any of the above (section 51, Medicines Act).
In addition, advertisements to the public relating to medicinal products must comply with the HSA Guide on Advertisement and Sales Promotions of Medicinal Products and the Singapore Code of Advertising Practice.
Currently, traditional medicines and homoeopathic medicines are not subject to pre-marketing approval and licensing for their import, manufacture and sale in Singapore. Responsibility for the safety and quality of traditional medicines and homoeopathic medicines rests with the dealers (importers, manufacturers and wholesale dealers) and sellers, who must ensure that their products do not:
Contain any other substances than those stated on the labels.
Contain prohibited substances, including amygdalin, pangamic acid, danthron, suprofen and rhodamine B.
Exceed the toxic heavy metals limits (that is, arsenic (five ppm), copper (150 ppm), lead (20 ppm) and mercury (0.5 ppm)).
Mention any of the 19 diseases/conditions specified in the Schedule to the Medicines (Advertisement and Sale) Act (for example, blindness, cancer, drug addiction, deafness, and so on) on the labels and packaging materials.
Alternative medicines containing animal parts are also subject to the TSE guidelines issued by the HSA.
Alternative medicines are subject to the advertising controls as set out in the Medicines Act and the Medicines (Advertisement and Sale) Act (see above). Additionally, the HSA has issued guidelines in relation to advertisements of traditional medicine materials.
Health supplements are not subject to pre-market approvals and licensing for their import, manufacture and sale in Singapore. Responsibility for the safety and quality of health supplements rests with the dealers and sellers.
The HSA Health Supplements Guidelines set out various safety and quality requirements. Speciﬁcally, health supplements must, among others:
Not contain any other substances than those stated on the label.
Not contain any human part or substance derived from any part of the human body.
Not contain poisons.
Not contain any substances prohibited under the Sale of Drugs Act.
Not exceed the limits for microbial contamination and toxic heavy metals specified in the HSA Health Supplements Guidelines.
Not contain any substance above the limit speciﬁed in the list of restricted substances included in the HSA Health Supplements Guidelines.
Not contain any substance speciﬁed in the list of prohibited substances included in the HSA Health Supplements Guidelines.
Not contain any substance that may adversely affect the health of the person taking the product.
Not make any claim that directly or indirectly refers to the list of conditions, diseases and disorders specified in the HSA Health Supplements Guidelines (for example, cardiovascular diseases and disorders, dental and periodontal diseases and disorders, metabolic disorders including obesity, and so on).
Not contain agents that can lead to animal-transmissible diseases such as TSE, if they contain ingredients derived from animal sources.
Be of acceptable standards of quality in terms of product stability, have an adequate shelf-life period, proper packaging and labelling, and be manufactured and/or assembled under proper conditions.
Health supplements that are considered to be medicinal products (for example, vitamins and minerals preparations, and some herbal preparations) are subject to medical advertising controls that apply to other medicinal products (see above).
The Health Sciences Authority (HSA) is the regulatory body responsible for issuing import, wholesale dealer's, manufacturer's and assembler's licences for Chinese proprietary medicines. There is no licensing framework in place for the sale of Chinese proprietary medicines.
There is currently no licensing framework in place for the manufacture and sale of alternative medicines and health supplements. Persons dealing with those products must ensure that they comply with their various legal obligations.
The HSA is the regulatory body responsible for granting permits relating to the advertisement of Chinese proprietary medicines, alternative medicines and health supplements (where necessary).
For more information on the HSA see box: The regulatory authorities.
When granting an import, a wholesaler, dealer's, manufacturer's or assembler's licence for Chinese Proprietary medicines, the Health Sciences Authority requires information on whether the medicines have received product registration certiﬁcates (if applicable), or free sale certiﬁcates from the country of manufacture. However, there is currently no formal indication that proof of such certiﬁcations will expedite or simplify the licensing process.
There are no licensing requirements for the import, manufacture and sale of alternative medicines and health supplements in Singapore.
Importers of Chinese proprietary medicines must ﬁrst obtain an import licence while manufacturers who manufacture Chinese proprietary medicines locally for export will need to obtain a manufacturer's licence (see Question 20, Chinese proprietary medicines). No licences are required for the export of Chinese proprietary medicines manufactured in Singapore. To assist local manufacturers with exporting their products, the Health Sciences Authority (HSA) may, on application, issue certificates for exporter of Chinese proprietary medicines to local manufacturers that conform to required standards of quality. Dealers who import Chinese proprietary medicines solely for the purpose of re-export must apply to the HSA for approval to import these products.
There are no licensing requirements for the import or export of alternative medicines.
Dealers who import Chinese proprietary medicines, alternative medicines or health supplements containing substances listed under the Endangered Species (Import & Export) Act (Cap 92A) must ﬁrst obtain an import permit from the Agri-Food & Veterinary Authority of Singapore.
Chinese proprietary medicines and alternative medicines are subject to the advertising restrictions set out in the Medicines Act and the Medicines (Advertisement and Sale) Act (see Question 20).
While the Health Sciences Authority's (HSA's) Health Supplements Guidelines allow health supplements to make nutritional (general) health claims and functional health claims, it also includes a list of conditions, diseases and disorders that health supplements are not permitted to make reference to in their advertisements. There are also general principles for product claims made about health supplements so that they do not convey misleading messages that could lead to inappropriate use of the products or cause undue harm to the public. For example, all claims must:
Not exploit the public's fears.
Health supplements that are considered to be medicinal products (for example, vitamins and minerals preparations, and some herbal preparations) are subjected to medical advertisement controls described in Question 20.
The Health Sciences Authority (HSA) recently finalised the import of the regulatory provisions on medicinal products (which were previously regulated by the Medicines Act and the Poisons Act) into the Health Products Act, through the creation of a new category of regulatory products known as "therapeutic products". This is part of the HSA's efforts to consolidate and streamline the regulatory controls of health products under a single piece of legislation, namely the Health Products Act. The aim is to provide clarity by having a single law to refer to, and to have regulatory controls stratified based on the risk profiles of the various categories of health products.
A public consultation was recently held on the proposed regulatory guidelines for telehealth devices. Telehealth devices are instruments, apparatus, machines or software (including mobile applications) that are involved in the provision of distance healthcare services through information and communication technologies, categorised into three broad service areas: clinical services, education and administration. The proposals in this regard include:
The classification of telehealth devices as medical devices where the intended use of the device is:
the diagnosis of diseases or medical conditions;
the cure, mitigation, treatment or prevention of diseases; or
to affect the structure or any function of the body of humans.
Clarification that telehealth devices intended for general well-being purposes (for example, wireless wearable pedometers and heart-rate monitors in smart phones or watches) are not to be regulated as medical devices.
The regulatory authorities
Health Sciences Authority of Singapore (HSA)
Principal responsibilities. The HSA's work includes a wide spectrum of scientific and professional functions, including:
Regulating health products to meet standards of safety, quality and efficacy.
Serving the administration of justice through its capabilities in forensic medicine, forensic science and analytical chemistry testing.
Securing Singapore's blood supply by ensuring a safe and adequate blood supply for public and private hospitals.
Singapore statutes online
Description. Singapore statutes online contains the full text of the Singapore statutes. It is run by the Attorney-General's Chambers of Singapore, and is updated consistently.
Benjamin Gaw, Director (Healthcare and Life Sciences Practice Group) (Corporate & Commercial Practice Group)
Drew & Napier LLC
Professional qualifications. Singapore Bar, 2003; England and Wales, Solicitor, 2009
Areas of practice. Healthcare and life sciences; corporate and commercial law; employment law; telecommunications, media and technology.
Non-professional qualifications. LLB (Hons), National University of Singapore, 2002; Specialist Diploma in Molecular Biotechnology, Ngee Ann Polytechnic, 2007
Languages. English, Mandarin
Member, Singapore Academy of Law's Committee on Legal Education and Studies.
Member, Inquiry Panel.
Member, Law Society of Singapore.
Member, Singapore Academy of Law.
Singapore chapter of Life Sciences, Getting the Deal Through, 2011, 2012, 2014, 2015 and 2016.
"Life Sciences Jurisdictional Guide to Singapore", Practical Law Company Multi-Jurisdictional Guide 2013.
"Ethical Guidelines for Human Biomedical Research Legislation in Singapore" in Asian Legal Business, November 2012.
Singapore chapter of "Global Pharmacovigilance Laws & Regulations: The Essential Reference" published by the Food & Drug Law Institute (which has been described as a "groundbreaking book" and a "landmark guide").
"Legislating the Fruits of Biotechnology: Suggestions for Regulating Bio-engineered Food" by the Singapore Law Review (See (2001 – 2) 22 Sing LR).