Malaysia: Class A devices exempted from conformity assessment; some other devices from registration requirements
The Malaysian government exempted all types of Class A (lowest-risk) devices from conformity assessment requirements to make it easier for companies to bring such products to the market. These devices, however, will have to continue complying with other regulatory requirements such as labelling and post-marketing commitments.
Also it is mandatory for most types of Class A devices to be formally registered with the Medical Device Authority (MDA).
Additionally, the government exempted certain types of medical devices from formal product registration requirements. These devices are also exempted from requirements for an establishment license. These exemptions will be allowed only after sponsors of such devices notify the MDA about their products so that the agency may issue a no-objection letter to permit these devices to be imported and/or placed on the market.
- EU: Revised Guidance on Clinical Evaluation – MEDDEV 2.7.1 (rev. 4)
- EU: MDR-Medical Device Regulation – consolidated text
- Germany: Regulation on unannounced audits
- Canada: Medical Device Single Audit Program (MDSAP) Transition Plan – FAQ issued
- Malaysia: Class A devices exempted from conformity assessment; some other devices from registration requirements