The Malaysian Medical Device Authority (MDA) has published an updated circular regarding the conformity assessment procedures for medical devices approved by recognised countries, in October 2021.
The updates that have been implemented are regarding the recognised foreign regulatory authorities and notified bodies. One of the updates is the addition of approval type issued by the regulatory authority, which is the EC Certification (CE Marking) against the European Union (EU) Medical Device Regulations and EU IVD Regulations. An alternative is for the medical device to be listed in the European Database on Medical Devices (EUDAMED).
Additionally, the Medicines and Healthcare products Regulatory Agency (MHRA), UK, has been added as a recognised foreign regulatory authority and its approval type for Great Britain and Northern Ireland, which are the public access database for Medical Device Registration, UK Conformity Assessed (UKCA Certification), EC (CE Marking) and UKNI Certification.
More details can be found in:
- “Conformity Assessment Procedures for Medical Device Approved by Recognised Countries, Revision 4, October 2021”: https://www.mda.gov.my/documents/ukk/1774-surat-pekliling-pbpp-bil-2-2014-eng-revision-4-1/file.html