Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
January 26, 2026
Approximately 5 minutes
Renewing Medical Device Dealer's Licence in Singapore
Renewing Medical Device Dealer's Licence in Singapore
1. Overview
Medical device dealers must renew their licences before expiry to continue authorised activities such as manufacturing, importing, or wholesaling medical devices in Singapore. Renewal applications are submitted through the SHARE system. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/renew
2. Renewal Process
Submit a renewal application via the SHARE portal at https://share.hsa.gov.sg/Login. Refer to the Applicant User Manual available on the HSA website for detailed submission steps. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/renew
3. Required Documents
For renewal, provide:
- Updated Quality Management System (QMS) certificate from an accredited Certification Body (e.g., MDSAP, ISO 13485, or GDPMDS).
- Declaration of Conformity to QMS (if applicable, e.g., for Class A devices).
- Any other supporting documents if there have been changes to QMS details since the last licence issuance.
Ensure the QMS certificate remains valid and covers the relevant scope of operations. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/renew
4. Fees and Turnaround Time
Fees for licence renewal are listed in the medical devices fees section on the HSA website. Processing times are not specified on the page. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/renew
5. Important Notes
- Submit renewal before licence expiry to avoid interruption of authorised activities.
- Failure to renew may result in licence lapse and inability to conduct regulated activities.
- Licence validity is typically tied to the QMS certificate expiry; renewals often align with certificate renewal.
- Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/renew
6. Related Resources
Refer to GN-02 Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices for additional details on QMS and renewal requirements. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/renew
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Applying for Medical Device Dealer's Licence in Singapore
Companies in Singapore must apply for a dealer's licence to manufacture, import, or wholesale medical devices, submitting via the SHARE system with required QMS certifications.
Approximately 5 minutes
Amending Medical Device Dealer's Licence in Singapore
Dealers must notify HSA of changes to their medical device licence details in Singapore, such as QMS certifications and site addresses, to maintain validity, submitting amendments via the SHARE system.
Approximately 5 minutes
Quality Management System Requirements for Medical Device Dealers in Singapore
Medical device dealers in Singapore must implement and maintain an appropriate Quality Management System such as GDPMDS or ISO 13485 depending on licence type to ensure consistent quality, safety, and performance throughout distribution activities.
Approximately 5 minutes
Certificates of Free Sale and Conformity for Medical Devices in Singapore
The Health Sciences Authority issues Certificates of Free Sale and Certificates of Conformity to support Singapore-registered medical devices for export, demonstrating compliance with local regulatory standards.
Approximately 5 minutes
Custom-Made Medical Devices Regulatory Pathway in Singapore
Custom-made medical devices in Singapore are exempt from full registration but require notification to HSA, with specific labelling, documentation, and record-keeping obligations to ensure patient safety.