Applying for Medical Device Dealer's Licence in Singapore

1. Overview

A dealer's licence is mandatory for manufacturers, importers, and wholesalers of medical devices in Singapore to ensure compliance with regulatory standards. Applications are submitted through the SHARE system. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

2. Types of Licences

Importer's Licence

This licence permits the import of medical devices into Singapore. Licensed importers also need a Wholesaler's licence for wholesale supply activities. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

Wholesaler's Licence

Allows wholesale supply, including export, to parties for re-supply, or as commercial samples. It is not required for direct supply to end-users, such as retail sales. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

Manufacturer's Licence

Permits the making, fabricating, producing, processing, packaging, and labelling of medical devices before supply. Licensed manufacturers do not need a Wholesaler's licence for their manufactured devices. Additional controlled drug licences are required for import, supply, and manufacture of drug of abuse test kits under the Misuse of Drugs Act. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

3. Eligibility Criteria

Eligibility depends on providing appropriate Quality Management System (QMS) documents, such as MDSAP, ISO 13485, or GDPMDS certificates issued by a certification body accredited by the Singapore Accreditation Council (SAC), or declarations of exemption or conformity where applicable. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

4. Application Process

Applications for all dealer's licences are made using the SHARE system at https://share.hsa.gov.sg/Login. A guide to new applications is available on the HSA website. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

5. Required Documents

Documents vary by licence type:

For Importer's Licence

• MDSAP certificate, ISO 13485 certificate (scope including distribution), GDPMDS certificate, Declaration of Exemption from GDPMDS (for re-export or non-clinical use), or Declaration of Conformity to a QMS (Class A devices only).
• Guide to new application.

For Wholesaler's Licence

• Similar to Importer's: MDSAP, ISO 13485, GDPMDS, exemptions, or conformity declarations.
• Guide to new application.

For Manufacturer's Licence

• MDSAP or ISO 13485 certificate, or Declaration of Conformity to ISO 13485 (Class A only).
• ISO 13485 issued by SAC-accredited body.
• Guide to new application.

Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

6. Fees and Turnaround Times

Detailed fees and processing times are listed in the medical devices fees section on the HSA website. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/apply

7. Important Notes and Updates

Applications can be withdrawn via SHARE while in progress. Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/apply