BSI awarded with local ISO 13485 accreditation by the Singapore Accreditation Council (SAC)
[Contenuto in lingua inglese]
Date: 12 July 2023
In Singapore, local medical devices companies are required to be licensed by the Health Sciences Authority (HSA) to manufacture, import or supply by wholesale. ISO certification represents a pre-requisite to obtain HSA license for manufacturers, importers and wholesalers.
Certification is performed by 3rd party Certification Bodies (CBs) which must be accredited by the Singapore Accreditation Council (SAC) for the following reasons:
- To ensure consistency and quality in the certification process across various CBs
- To ensure the ISO13485 certification locally is in line with international medical device regulatory principles
From 1 January 2025, only ISO 13485 issued by SAC accredited Certification Bodies will be accepted for Medical Devices license applications in Singapore.
We are pleased to inform you that on 5 June 2023, BSI was awarded accreditation in the field of Medical Devices Quality Management System - ISO 13485:2016 with Singapore Accreditation Council (SAC).
The accreditation covers the following scopes:
|
Main Technical Area(s) |
Technical Area(s) |
|
Non-Active Medical Devices |
General non-active, non-implantable medical devices |
|
Non-active implants |
|
|
Devices for wound care |
|
|
Non-active dental devices and accessories |
|
|
Non-active medical devices other than specified above |
|
|
Active Medical Devices (Non-implantable) |
General active medical devices |
|
Active (non-implantable) medical devices other than specified above |
|
|
Active Implantable Medical Devices |
General active implantable medical devices |
|
Sterilisation Method for Medical Devices |
Ethylene oxide gas sterilization (EOG) |
|
Moist heat |
|
|
Aseptic processing |
|
|
Radiation sterilization (e.g., gamma, x-ray, electron beam) |
|
|
Low temperature steam and formaldehyde sterilization |
|
|
Thermic sterilization with dry heat |
|
|
Sterilization with hydrogen peroxide |
|
|
Sterilization method other than specified above |
|
|
Parts or Services |
Raw materials |
|
Components |
|
|
Subassemblies |
|
|
Calibration services |
|
|
Distribution services |
|
|
Maintenance services |
|
|
Transportation services |
|
|
Other services |
A list of SAC accredited CBs for MDQMS (i.e., ISO13485) can be found on SAC’s website. This list will be updated upon addition of new accredited CBs.
We encourage you to submit your application as soon as possible to be able to maintain your license with HSA to manufacture, import or supply medical devices in Singapore.
For certification enquiry or further information on BSI Singapore Certification, please visit our dedicated webpage or contact us at info.sg@bsigroup.com.
Yours sincerely,
Graeme Tunbridge, BSI SVP Regulatory and Quality
Regulatory Services
