Chapter 1 Singaporean Administration

1. Singaporean HAS

The Health Science Authority (HSA) regulates the import, manufacture, export and supply of medical devices in Singapore to safeguard public health and safety.

Before obtaining distribution permission, medical devices must submit product documents online through the Medical Device Information and Communication System (MEDICS), and the products can be legally sold after being listed or registered.

2. Administrative Regulation

As a country with high health supervision, Singapore has strict requirements for the entire framework system, and the overall requirements are relatively close to Europe and the United States

Health Products Act 2007

Health Products (Medical Devices) Regulations 2010

ASEAN Medical Devices Directive (AMDD)

3. Risk Level Classification

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

Method 1: See GN-13-R2.1 Guidance on the Risk Classification of General Medical Devices and GN-14-R2 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices, according to which the product risk level is determined.

Method 2: Use the risk level decision tool on the official website to judge HSA | Medical device risk classification tool

Method 3: Check the risk level of similar products using the Public Enquiry - Singapore Medical Device Register (SMDR).

4. Entry Requirements

Medical devices and IVD products require a valid ISO 13485 certificate to be submitted for HSA registration. The registration process can be accelerated if a certificate of registration from a reference country is provided. Currently, HSA recognizes certificates of registration from reference countries:

- Australian TGA Certificate

- CE Certificate

- Canadian MDL certificate

- Japan MHLW Certificate

- FDA clearance/De Novo/PMA

Singapore allows devices to be grouped and named as Single, Family, System, Test kit, or Group. The official decision widget HSA | Medical device grouping tool is available.

Product registration information must be prepared in accordance with the ASEAN Common Submission Dossier Template (CSDT).

In Singapore, applications must be submitted online through the Medical Device Information and Communication System (MEDICS). Prior to submission, companies must apply for a CRIS (Customer Registration and Identification Service) account and register as a CRIS administrator to access MEDICS

The applicant must be a local entity, otherwise, the local entity must be authorized as the authorized representative and also the registrant

Designated importers and wholesalers must have a distributor license that complies with the Good Distribution Practice for Medical Devices GDPMDS or ISO 13485

GDPMDS certification should be obtained from a certification body accredited by the Singapore Accreditation Council (refer to Wiselink SG's GDPMDS certificate template).

5. Registration Language

English.

Chapter 2 Registration Flow, Approach、Cycle & Official Fee

1. Registration Flow 

Non-sterile Class A medical devices may be exempted from registration, but the Class A exemption list in the Medical Device Information and Communication System (MEDICS) must be completed and notified to the HSA during the dealer license application.

Sterile Class A medical devices (including in vitro diagnostic devices) still need to be registered.

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

4. Local Representative (permit holder) Requirements

①Registrants do not need a license from the HSA, but must register with the Medical Device Information and Communication System (MEDICS) Medical Device Information Communication System.

② All medical devices must be submitted by the registrant, who makes the submission and is responsible for some activities after the listing.

③The registrant also needs to supervise and control the manufacturer's authorized import list in Singapore. If the registrant is an independent third party, it needs to authorize the distributor or importer to complete the entire closed-loop work.

④ The same device can be registered by multiple registrants. If the relationship between the business and the previous registrant is broken, it must be re-registered unless the previous registrant is willing to transfer the certificate.

⑤Licensed importers require an ISO 13485 and/or Good Distribution Practice for Medical Devices - Singapore (GDPMD-S) license and must be registered with the HSA.

Chapter 3 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.

Chapter 4. Certificate template