Medical Device Authority (MDA) allows for medium and high-risk class medical devices to undergo conformity assessment by way of verification of the evidence for medical devices that have been approved by recognised regulatory authorities or notified bodies. Until recently, MDA only recognised 5 regulatory agencies on this basis, namely Therapeutic Goods Administration (TGA) Australia, Health Canada, notified bodies listed in New Approach Notified and Designated Organisations (NANDO) database of European Union (EU), Ministry of Health, Labour and Welfare (MHLW) Japan, and Food and Drug Administration (FDA) USA.


Any medical devices with no active registrations in either one of these agencies will be subjected to a full conformity assessment by local conformity assessment bodies, before evaluated by MDA.


In mid-October 2021, MDA has added a new recognised reference agency to its list. Any medical devices with prior approval from Medicines and Healthcare products Regulatory Agency (MHRA), UK granting approval for devices in the Great Britain and Northern Ireland market, shall now be eligible for a conformity assessment by way of verification of the evidence, also. For this the devices have to be listed in Public Access Database for Medical Device Registration or hold a UKCA Certification or an EC (CE Marking) and UKNI Certification.


On top of this new addition, MDA also recognises medical devices granted approval by the notified bodies listed in NANDO database of the EU and have EC Certification (CE Marking) against EU Medical Device Regulations and EU IVD Regulations or listed in European Database on Medical Devices (EUDAMED).


This proves to be good news for manufacturers whose medical devices hold an MHRA approval only, following the Brexit.



Conformity Assessment Procedures for Medical Device Approved by Recognised Countries