Medical device distribution in Singapore
Only registered medical devices may be distributed in Singapore, which means that the product is listed on the Singapore Medical Device Register (SMDR), unless exempted from registration (all Class A products).
Who can distribute medical devices in Singapore?
- Only a company with a valid Wholesaler’s License (otherwise known as a medical distributor license) from the Health Sciences Authority may distribute medical devices in Singapore. This company may also hold an Importer’s License to also act as an importer for your medical device. Wholesalers may also supply commercial samples and export your medical device to third countries.
- What is important to remember is that multiple importers and wholesalers may be appointed in Singapore. This means you can have several distribution channels available to you at any one time. The best way of taking advantage of this opportunity is to appoint a Local Authorized Representative (LAR) who will be the Registrant for your medical devices, which means that you only need to register your medical devices once. The LAR then adds your selected Importers and/or Wholesalers to the MEDICS online portal. Otherwise, each time you add a “distributor” you will be required to either register your medical device again with the cost and time delay involved or you will have to pay a transfer fee.
- Choosing to work with an LAR rather than directly with an importer or wholesaler gives you real flexibility in your distribution strategy. This means you can adapt quickly to changes in the market by adding new distributors, increase transfer pricing as well as ensuring rigorous quality and compliance controls
What are the requirements for distributing medical devices in Singapore?
- Only local Singaporean companies can apply for a Wholesaler’s License. The company must have a Client Registration and Identification Service (CRIS) company account from the Health Sciences Authority (HSA) in order to apply for this license.
- The company must also hold valid Good Distribution Practice for Medical Devices (GDPMDS) certification that has been performed by accredited certification bodies listed with the Singapore Accreditation Council or an ISO 13485 certificate that specifies storage and distribution of the categories of medical devices concerned and the activities performed at the facility
- Companies dealing in ONLY Class A devices may submit a declaration of conformity to a Quality Management System (QMS) in lieu of ISO 13485 or GDPMDS certification when applying for the Wholesaler License.
Advertising rules
Advertising, communication and promotion of medical devices is a common part of a distribution contract, either falling to the manufacturer or the local distributor to undertake. Please note, that in Singapore, advertisements of medical devices do not require prior approval by the HSA. Moreover, you have to ensure that the advertisements comply with the requirements stated in the Health Products Act and the Regulations. Guidance on adverts and sales promotion exists in guidance document GN-08.
Distributor’s duties and obligations
It is mandatory for wholesalers (distributors) of medical devices and IVDs to Singapore to:
- maintain their GDPMDS certification and a valid Wholesaler’s License
- maintain a record of all imports and exports
- maintain records of any complaints
- report any Adverse Events (AE) or Field Safety Corrective Actions (FSCA) to the Health Sciences Authority as well as to the Local Authorized Representative
How Andaman Medical can help with distributing medical devices in Singapore:
Acting as your independent local authorized representative or marketing authorization holder in Singapore, we will register and maintain your device license which also means you can appoint as many wholesalers for your device as you require while the product license is not affected by any changes in your distributor network. We will work with your chosen distributors to:
- add your selected Wholesalers for your devices to the MEDICS online portal
- liaise with your licensed Wholesalers concerning the post-market surveillance of your registered product including the mandatory reporting of Adverse Events and Field Safety Corrective Actions
- and of course, carry out our full range of registration, LAR and post-market surveillance services
We also offer additional support services such as:
- Online regulatory training
- Regulatory intelligence reports giving you insight into the best routes for market access and the latest on the regulatory landscape in your target market