HSA conducted a webinar last March 2, 2021 discussing the future of ISO 13485 Certification for Medical Device Dealers in Singapore. The webinar shares plans of accreditation of CBs that certifies local medical device dealers. The dealers are expected to transition to these accredited CBs. Upon full implementation, ISO13485 from accredited CBs will be accepted for Medical Device license applications
Medical Device Dealers Control
Local companies that are into the manufacturing, importation, and supply of medical devices must secure a Dealer’s License from the HSA; this license is dependent on the company’s activities, which falls into three types:
- - Local Manufacturing –Manufacturer’s license
- - Importation –Importer’s license
- - Wholesaling (including Exportation) – Wholesaler’s license
Pre – requisites
A Quality Management Systems (QMS) Certification is a pre – requisite in the application for a dealer’s license. Particularly, an ISO 13485 Certificate will suffice. For importers and wholesalers, the certificate must indicate the scope of the storage and distribution. Alternatively, a GDPMDS* SS 620**certificate may also be submitted. For dealers of Class A medical devices, a Declaration of Conformity to a QMS can be submitted in lieu of a certificate.
Accreditation for GDPMDS Certification
Certification for Good Distribution Practice for Medical Devices (GDPMDS) must be done by 3rd party certification bodies (CBs). As of the moment, there are 10 accredited CBs by the Singapore Accreditation Council (SAC). These CBs shall undergo the Witnessed Assessment Program by HSA to ensure that the technical requirements for GDPMDs are appropriately applied and the interpretation among CBs are developed consistently.
Accreditation for ISO 13485 Certification
Regulating bodies of medical devices are currently moving forward with the leveraging of ISO 13485 audit reports/certifications from equivalent regulating bodies in another jurisdiction. One such example is Medical Device Single Audit Program (MDSAP) under International Medical Device Regulators Forum (IMDRF). This harmonization avoids multiple audits of the same manufacturing facility and effort duplication will be reduced. In addition, it will provide a robust local certification with oversight for a regulating body (e.g., HSA). This will ensure that the certification process is consistent and has a high quality and are in line with international medical device regulatory principles.
The SAC, on the other hand, has a system in place for the accreditation of certificate issuances with the CBs in Singapore. As mentioned in the previous section, the CBs will be subjected to Witnessed Assessment Program, similar to GDPMDS certification.
Proposed Implementation Plan for Accredited ISO 13485 Certification
The proposed implementation timeline for the accredited ISO 13485 certification is:
- - End of 2021 – ISO 13485 CBs to acquire SAC accreditation
- - 2022 – Transition period for dealers to SAC accredited CBs
- - January 1, 2025 – Only ISO 13485 Certificates issued by SAC accredited CBs will be accepted for medical device license applications.