Medical device importation to Singapore
Only registered medical devices may be imported into Singapore, which means that the product is listed on the Singapore Medical Device Register (SMDR) unless exempted from registration (all Class A products). Any company wishing to import medical devices and in-vitro diagnostics (IVDs) into Singapore must have a valid Importer’s License from the Health Sciences Authority.
What are the requirements for importing medical devices into Singapore?
- Only local Singaporean companies can apply for an Importer’s License. The company must have a Client Registration and Identification Service (CRIS) company account from the Health Sciences Authority (HSA) and a valid Importer’s License or Wholesaler’s License (import and export).
- 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 import, storage and/or distribution of the categories of medical devices concerned and the activities performed at the facility
- Companies dealing in Class A devices ONLY may submit a declaration of conformity to a Quality Management System (QMS) in lieu of ISO 13485 or GDPMDS certification when applying for the Importer License.
Are there any exemptions?
- Even though all Class A medical devices are exempted from product registration, an Importer’s License is still required. Dealers wishing to import these products are also required to declare the list of such products in the Class A Medical Device Exemption List.
- Certain products may be imported using Special Access Routes (see below).
Special Access Routes for importing medical devices into Singapore
- Unregistered medical devices that have been requested for a named patient by a healthcare practitioner may be imported if a lack of registered alternative is proven – this route requires the importer to have GDPMDS.
- Unregistered medical devices that have been requested for use in licensed healthcare institutions may be imported if a lack of registered alternative is proven – this route requires the importer to have GDPMDS.
- Products that are destined for non-clinical purposes such as training or research.
- Products for the purpose of export or re-export.
Importers duties and obligations
It is mandatory for importers of medical devices and IVDs to Singapore to:
- maintain their GDPMDS certification and a valid Importer’s or Wholesaler’s Licence
- maintain a record of all imports (and exports)
- maintain records of any complaints
- report any adverse events or field safety corrective actions to the Health Sciences Authority as well as to your local authorized representative.
How Andaman Medical can help with importing medical devices to Singapore:
Acting as your independent local authorized representative or marketing authorization holder in Singapore means you retain the freedom to appoint as many importers or wholesalers for your device as you require, while your product license remains unaffected by any changes in your distributor network. We will work with your appointed importers and/or wholesalers to:
- add your selected importers and/or wholesalers for your devices to the MEDICS online portal
- liaise with your licensed importers/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:
- 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.