Pregnancy Test Kit Registration in Malaysia: Classification & Regulatory Requirements
Quick Answer A pregnancy test kit sold in Malaysia is a Class B IVD under the MDA IVD classification rules (MDA/GD/0001). Registration is mandatory under Act 737 and must be submitted through a licensed Local Authorised Representative (LAR) via the MeDC@St portal, with CAB conformity assessment completed before MDA will accept the application. Pregnancy test …
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