NEW RELEASE GUIDANCE DOCUMENT MDA/GD/0023: CONFORMITY ASSESSMENT BODY (CAB) - REQUIREMENT FOR REGISTRATION

NEW RELEASE GUIDANCE DOCUMENT

MDA/GD/0023: CONFORMITY ASSESSMENT BODY (CAB) - REQUIREMENT FOR REGISTRATION

This Guidance Document was prepared by the Medical Device Authority (MDA) to help the Conformity Assessment Body (CAB) 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.

To view the guidance document CLICK HERE