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Guidance Document under Medical Device Act 2012 ( Act 737)

These Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.

This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following;
a) Medical Device Act 2012 (Act 737); and
b) Medical Device Regulations 2012.

List of guidance documents:

MDA/GD/0025 Declaration of Conformity (DoC)MDA/GD/0002 IN-VITRO DIAGNOSTIC (IVD) MEDICAL DEVICE CLASSIFICATION SYSTEMMDA/GD/0054 Product Grouping for In-Vitro Diagnostic (IVD) Medical Devices