CIRCULAR LETTER OF THE MEDICAL DEVICE AUTHORITY

NO. 4 YEAR 2017

(RECOGNITION OF INSTITUTE FOR MEDICAL RESEARCH (IMR) TO PROVIDE THE REPORT OR DATA OF CLINICAL EVIDENCE OR PERFORMANCE EVALUATION FOR THE PURPOSE OF CONFORMITY ASSESSMENT BY CONFORMITY ASSESSMENT BODY)

 

This Circular Letter was prepared by the Medical Device Authority (MDA) to facilitate the stakeholder and industry in the implementation of Medical Device Act (Act 737) Medical Device Act (Act 737) and the regulations under it.

This Circular Letter 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;

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