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Singapore Medical Device Regulatory Authority

The regulation of medical devices in Singapore is the responsibility of the Health Sciences Authority (HSA). Its core responsibilities are to regulate the import, manufacture, export, and supply of medical devices in Singapore, safeguarding public health and safety.

Medical devices must first submit product documents through the online system SHARE. Only after completing product listing or registration can they be legally marketed and sold in Singapore.

Regulatory authority official website link: https://www.hsa.gov.sg/

Database link: https://www.hsa.gov.sg/medical-devices/e-services

HSA risk classification tool official website:https://www.hsa.gov.sg/medical-devices/registration/risk-classification

Administrative Regulation

Singapore has strict regulatory requirements for medical devices, with an overall framework closely aligned with European and American standards. The core regulatory regulations include:

Health Products Act 2007
Health Products (Medical Devices) Regulations 2010
ASEAN Medical Device Directive (AMDD)

Risk Level Classification

The methods for determining the risk classification of a product are as follows:

① Refer to the classification rules of GN-13-R2.1 Guidance on the Risk Classification of General Medical Devices and GN-14-R3 Guidance on the Risk Classification of IVD Medical Devices for assessment;

② Use the risk classification decision tool on the HSA official website (HSA | Medical device risk classification tool);

③ Search the Singapore Medical Device Register (SMDR) via the Public Enquiry database to check the risk classification of similar products.

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Registration Basis

1.Submit corresponding QMS evidence based on the registration pathway/license type. ISO 13485 is not the only option; providing reference country registration certificates may expedite the registration process. HSA-recognized reference country certificates include: Australia TGA certificate, CE certificate, Canada MDL certificate, Japan MHLW certificate, US FDA clearance/De Novo/PMA.

2.Singapore allows device grouping applications, including Single, Family, System, Test kit, or Group. The official tool (HSA | Medical device grouping tool) can assist in determining the grouping.

3.Registration documents must be prepared in accordance with the ASEAN Common Submission Dossier Template (CSDT) and submitted online via the SHARE system. Prior to submission, companies are required to apply for a CRIS (Customer Registration and Identification Service) account and register as a CRIS administrator.

4.The applicant must be a locally incorporated entity in Singapore. Non-local companies must authorize a local entity as their Authorized Representative (i.e., Registrant).

5.Importers require an Importer’s licence; wholesale suppliers require a Wholesaler’s licence. Corresponding QMS evidence must be submitted with the application. GDPMDS certification must be issued by a body accredited by the Singapore Accreditation Council.

Registration Language

English.

Local Representative (License Holder) Requirements

① The Registrant is not required to hold an HSA license but must complete registration in the SHARE system.

② All medical device registration applications must be submitted by the Registrant, who is also responsible for post-market activities related to the product.

③ The Registrant must oversee the list of authorized importers of the manufacturer in Singapore. If the Registrant is an independent third party, they must authorize distributors or importers to complete the full closed-loop process.

④ The same device may be registered by multiple Registrants. If the cooperation with the previous Registrant terminates and the previous Registrant is unwilling to transfer the certificate, a new registration is required.

⑤ Licensed importers are required to hold an ISO 13485 certificate and/or Good Distribution Practice for Medical Devices – Singapore (GDPMD-S) license, and complete HSA registration.

Registration Flow, Approach、Cycle & Official Fee

1. Registration Flow

Note: Class A is exempt from product registration, but manufacturing/importing Class A requires submission of Class A product notification; only Class B/C/D require product registration.

2. Registration Approach

3. Official Fee & Cycle

HSA | Fees and turnaround time for medical devices

Annual retention in the Singapore Medical Device Register (SMDR)

Change of registrant

Summarized as follows

七、FAQ

Q: Can the registration of medical device products be changed after registration?

A: Sure. If there is a significant change to a medical device product, a change request needs to be filed with the HSA.

Q: Does it require a QMS certificate for medical device registration?

A: HSA recognizes the ISO13485 certificate issued by a specific institution at the time of registration of medical devices. Wiselink recommends ISO13485 certificate issued by IAF member organizations according to project experience.

Q: What are the requirements for importers during the medical device registration process in Singapore?

A: Importer information is not required to be submitted during the product registration process, however, importer information is required to be provided and uploaded into the system by the Singapore licensee prior to the sale of the product.

Q: Can we register in Singapore without a registration certificate from my country of origin?

A: Sure.

Q: Can a Singapore Registration Certificate be transferred to another registrant?

A: Sure. The Health Products Act 2007 provides for the transfer of registrants in relation to a valid listing. Provide Registrant changes in the GN-24 Guidance on the Change of Registrant.

八、Certificate template

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