MALAYSIA: MDA ANNOUNCED A NEW APPROACH TO EXPIRED EC CERTIFICATES FOR NEW REGISTRATION AND RE-REGISTRATION OF MEDICAL DEVICE — AUGUST/SEPTEMBER 2023
- 2023-08-23 06:00:06
The Medical Device Authority's (MDA) approach to expired EC Certificates for New Registration and Re-Registration of Medical Devices has been loosened. In line with Directives 90/385/EEC and 93/42/EEC, MDA recognizes the EC Certificate (CE Marking) as one of the approved types of conformity assessment procedures by way of verification process for the purpose of medical device registration in Malaysia.
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