An Overview of the Basic Requirements and Registration Process for Engaging in the Medical Device Industry in Singapore

Author: Lawyer Zhang Jingxinyue, PRC-qualified Lawyer | Singapore Registered Foreign Lawyer

Editor's note: Despite its very small land area, Singapore has one of the largest and most advanced healthcare systems in the world. To a certain extent, Asia relies on Singapore's well-developed healthcare infrastructure. At the same time, Singapore is also one of the most important medical device markets in Asia. Recently, a friend in China who works in medical devices asked the editor: his company wants to enter the Singapore market and expand into Southeast Asia. What procedures are required to set up a company in Singapore and sell medical products? What key requirements should be noted?

Generally, Singapore's healthcare regulatory system is relatively industry-friendly, but at the same time the government is raising safety standards by expanding the range of medical products it reviews and approves. On the 18th of this month, Zhang Jingxinyue, lawyer and founder of China-Singapore Legal News, attended the World Cold-Region Medicine and Health Industry High-Quality Development Forum jointly held by the China Council for the Promotion of International Trade and the Jilin Provincial People's Government, and delivered a speech titled "Singapore Biomedical Industry Policies and the Path for Chinese Pharmaceutical Enterprises Going Overseas." In light of inquiries from medical device companies, this article again reviews the regulation of Singapore's medical device industry and matters relating to product registration procedures.

01 What are the regulatory authority and regulatory system for medical device registration in Singapore?

• The Health Sciences Authority (HSA) under Singapore's Ministry of Health is the statutory regulator for medical devices, pharmaceuticals, and cosmetics. Specifically, the Medical Devices Branch of the Therapeutic Products Department carries out medical device regulatory functions.
• Singapore is a member of the Association of Southeast Asian Nations (ASEAN), and its regulatory system is based on the 2007 Health Products Act and the 2010 Health Products (Medical Devices) Regulations. These laws govern the supply, distribution, manufacture, import, and advertising of medical device products, how products are classified, and the corresponding registration pathways.
• Registered medical devices are listed on the Singapore Medical Device Register (SMDR), which is publicly available on the HSA website.

02 What is the legislative process for the medical device industry in Singapore?

• Before 2007, apart from separate regulations such as the Contact Lens Practitioners Act and the Radiation Protection Act for contact lenses and radioactive medical devices, Singapore operated a voluntary registration system for most medical devices. However, manufacturers or their authorised local agents were required to ensure that relevant medical device products met safety, quality, and performance requirements. Higher-risk and high-risk medical devices had to be registered with the Singapore Health Sciences Authority before they could be sold.
• Singapore studied the medical device regulatory systems of developed countries, including the US FDA, EU Notified Bodies, Health Canada, Japan's Ministry of Health, Labour and Welfare, and Australia's TGA, and then adapted them to its own circumstances to form a medical device regulatory system suited to Singapore.
• In February 2007, the Health Products Act was enacted, and a series of guidance documents was issued, such as the Guidance for the Risk Classification of General Medical Devices, Guidance for Medical Device Product Registration, Guidance for the Application of Singapore Medical Device Distribution Practices, Guidance for the Licensing of Medical Device Manufacturers, Importers, and Wholesalers, Guidance for Preparing a Site Master File Licence, Guidance for Medical Device Recall, Guidance for Reporting Adverse Events of Medical Devices, Guidance for Medical Device Distribution Records, and Guidance for Medical Device Advertising and Promotion.

03 What is the definition of medical device products in Singapore?

"Medical device" means any instrument, apparatus, machine, appliance, implant, in vitro reagent, calibrator, software, material, or other similar or related article, whether used alone or in combination, intended for use in humans for one or more of the following specific purposes:

(1) diagnosis, prevention, monitoring, treatment, or alleviation of any disease;

(2) diagnosis, monitoring, treatment, alleviation of, or compensation for an injury;

(3) investigation, replacement, regulation, or support of an anatomical or physiological process;

(4) supporting or sustaining life;

(5) control of conception;

(6) disinfection of medical devices;

(7) providing medical information by means of in vitro examination of specimens derived from the human body.

04 How are medical device products classified in Singapore?

As described above, Singapore's medical device regulatory system is based on the 2007 Health Products Act and the 2010 Health Products (Medical Devices) Regulations, which set out how medical devices are classified in Singapore and the corresponding registration pathway for each category.

Singapore's medical device classification is based on a four-level classification system (Class A, Class B, Class C, and Class D)

Class A: low risk (e.g., surgical retractors, tongue depressors)

Class B: low-moderate risk (e.g., hypodermic needles, suction equipment)

Class C: moderate-high risk (e.g., lung ventilators, bone fixation plates)

Class D: high risk (e.g., heart valves, implantable defibrillators)

05 What are the market access conditions for medical device products in Singapore?

Medical device products must be registered before they can be sold.

After the Health Products Act took effect in 2007, Singapore has continuously strengthened its regulation of medical devices and implemented corresponding regulatory strategies in phases. From 2010, mandatory approval was adopted for Class C and Class D medical devices. From 2012, mandatory approval was extended to Class B and Class A medical devices. Except for exempted products, all categories of medical device products must be registered with HSA before they may be placed on the market and sold in Singapore.

The registrant or applicant must be a company registered in Singapore. All registered medical devices are listed in the Singapore Medical Device Register, and consumers may check online whether a purchased medical device product is a registered product.

For medical devices approved in the United States, European Union, Canada, Australia, or Japan, or for products with a prior safe history of market use, Singapore may adopt abridged, expedited, and immediate evaluation approaches.

Among them, the following regulatory organisations are regarded by HSA as independent reference agencies:

1. Health Canada (HC)
2. Japan's Ministry of Health, Labour and Welfare (MHLW)
3. U.S. Food and Drug Administration (US FDA)
4. Therapeutic Goods Administration / EU Notified Bodies (TGA/EU NB)

06 How should documents for an HSA medical device registration application be prepared?

The registration application submission documents or technical file for the Singapore Health Sciences Authority (HSA) are based on the ASEAN CSDT (Common Submission Dossier Template) format. The information required in the submission depends on your medical device classification and the selected evaluation route. Documentation from EU technical files can often be used to satisfy many supporting documentation requirements. A declaration of conformity must be prepared in accordance with the Essential Principles. Approved products will be listed in the Singapore Medical Device Register (SMDR) database.

07 Product registration process?

1. Class A non-sterile devices

Class A non-sterile medical devices are exempt from registration. However, Class A non-sterile medical devices require a local agent in Singapore with an appropriate wholesaler/importer licence. Although Class A non-sterile devices do not need to be registered with HSA before being placed on the market, before entering the Singapore market they must still comply with the Essential Principles of Safety and Performance for Medical Devices.

The approval process is as follows:

• Step 1: Submit an application dossier through the Medical Device Information and Communication System (MEDICS) — product application fees are charged immediately upon submission.
• Step 2: Review the application dossier — HSA's review is based on the supporting data submitted by the applicant. If clarification or additional information is required, HSA will issue a notice to the applicant.
• Step 3: Approval decision and listing on the SMDR — After reviewing the submitted application, HSA makes a regulatory decision. Products meeting the registration requirements will be registered and listed on the SMDR.

Approval time: approximately 1 month

2. Class B medical devices

There are four evaluation routes for Class B medical devices:

1. Full evaluation route — Medical devices that have not received any prior approval from any HSA reference regulatory agency at the time of application will be subject to the full evaluation route.
2. Abridged evaluation route — To be eligible, the medical device must have received approval from at least one regulatory agency, with labelling indications identical to those intended for marketing in Singapore at the time of submission.

1. Expedited Class B Registration (EBR) evaluation route

To be eligible for EBR1, the medical device must, at the time of submission, meet the following criteria:

• It has received approval from at least one HSA independent reference regulatory agency for the same labelled intended use as that proposed for marketing in Singapore.
• It has been marketed in the jurisdiction of the above independent reference regulatory agency for at least three years.
• In the past three years, there have been no global safety issues related to the use of the medical device when used as intended by the product owner.

To be eligible for EBR2, the medical device must, at the time of submission, have received approval from at least two HSA independent reference regulatory agencies for the same labelled intended use as that proposed for marketing in Singapore.

The process for the above evaluation routes (1-3):

1. Submit an application through MEDICS
2. Application validation
3. Application evaluation
4. Regulatory decision and listing on the SMDR upon successful registration

2. Immediate Class B Registration (IBR) evaluation route

To be eligible for the IBR evaluation route, the medical device must meet the following criteria at the time of submission:

• It has received approval from at least two HSA independent reference regulatory agencies for the same labelled intended use as that proposed for marketing in Singapore.
• It has been marketed in the jurisdictions of the above two independent reference regulatory agencies for at least three years.
• In the past three years, there have been no global safety issues related to the use of the medical device when used as intended by the product owner.
• The medical device has not been refused or withdrawn by any reference regulatory agency/foreign jurisdiction, or by HSA/Singapore, due to quality, performance/efficacy, or safety issues.

The process for the IBR evaluation route:

1. Successful submission of application through MEDICS
2. The device is registered and listed on the SMDR
3. Document verification

3. Class C and Class D medical devices

There are three evaluation routes for Class C&D medical devices:

1. Full evaluation route (qualification definitions as above)
2. Abridged evaluation route (qualification definitions as above)
3. Expedited evaluation route

• Expedited Class C Registration (ECR) — same qualifications as EBR
• Expedited Class D Registration (EDR) — To qualify for EDR, the device must have received approval from at least two HSA independent reference regulatory agencies for the same labelled intended use as that proposed for marketing in Singapore.

The following devices are not eligible for EDR:

1. Active implantable devices
2. Implantable devices that come into direct contact with the central nervous system
3. Hip, knee, and shoulder joint replacements
4. Devices incorporating a registrable drug as an ancillary role, IVD devices used for HIV testing, or blood/tissue donor compatibility testing The process for the above evaluation routes (1-3):
5. Submit an application through MEDICS
6. Application validation
7. Application evaluation
8. Regulatory decision and listing on the SMDR upon successful registration

Medical Device Classification and Registration Timeline

08 Is local testing (type testing/sample testing) required for registration?

No, local testing is not required for registration in Singapore.

09 Is clinical research required for registration?

No, clinical research is generally not required for registration in Singapore.

10 What are the main matters that foreign medical device manufacturers need to address when entering Singapore? What agency services can Singapore service providers offer?

1. Incorporating a company

It is recommended to engage a Singapore corporate secretarial firm to handle incorporation and bank account opening. See Business Setup | 2021 Singapore Company Registration Guide | China-Singapore Legal News (However, over the past year or more, it has been difficult for foreign investors to obtain approval to incorporate a new company in Singapore and open a corporate bank account.)

2. Registering a trademark

You may engage a law firm or other institution that handles trademark registration.

3. Registering products (including applying for licences)

A foreign medical device manufacturer must appoint a registrant to submit the medical device registration application to the Singapore Health Sciences Authority (HSA) on its behalf. The registrant must be a Singapore-based company with local employees and registered with the Health Sciences Authority (HSA). The Singapore agent will control the applicant's medical device registration information, so care should be taken when selecting a registrant. Registration information may only be transferred to another registrant if the current registrant agrees to relinquish it.

A qualified registrant can help the applicant meet the relevant regulatory requirements and provide the following assistance:

• Determine the appropriate registration route for the applicant's medical device;
• Act as the local agent and liaise with the Health Sciences Authority (HSA) throughout the registration process;
• Assist in preparing technical documents to ensure compliance with the CSDT format;
• Identify opportunities to use authorisations and relevant supporting documents obtained in other markets to help the applicant complete registration procedures in Singapore more efficiently;
• Advise the applicant on the best grouping strategy to minimise registration-related costs;
• If necessary, also provide assistance with post-market surveillance, vigilance, and adverse event reporting.

Note here: the product registration process is relatively cumbersome, and licence review times are quite long. For example, a wholesale licence we handled took more than one year. In addition, there are not many registrants in Singapore, so it is not easy to find a suitable registrant.

11 What are the main expense items for setting up and operating a medical device company?

1. Company incorporation setup fees, first-year secretarial and director fees, deposits, and other expenses;
2. Trademark registration service fees;
3. Product registration service fees. Fees vary according to the different classifications.

12 Are there any requirements for office space, number of employees, or similar matters?

Regarding office space and employee numbers in the medical industry, the Singapore health authority has no explicit or special relevant requirements, but that does not mean there are no requirements. For example, a client we know in the medical industry employs several local employees and, as required by the health authority, rents a warehouse in Singapore to store pharmaceutical products. The company's annual operating costs are roughly tens of thousands of Singapore dollars.

• The above process and requirements are for reference only. For specific data and requirements, please refer to the Health Sciences Authority website.

https://www.hsa.gov.sg/medical-devices/

• For more inquiries about the Singapore biomedical and pharmaceutical industry, please contact the professional consultants at China-Singapore Legal News.

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Author｜Zhang Jingxinyue

This article is for informational reference only and does not constitute formal legal advice.

This article is general information and not legal advice. Specific matters require assessment by appropriately qualified professionals.