CIRCULAR LETTER OF THE MEDICAL DEVICE AUTHORITY

 

NO. 1 REGISTRATION REQUIREMENT AND EXEMPTION FROM LABELLING FOR EXPORT ONLY MEDICAL DEVICE,

 NO. 2 YEAR 2017 (NATIONAL PREPARATION TO RATIFY MINAMATA CONVENTION ON MERCURY) AND

NO.3 IMPLEMENTATION AND ENFORCEMENT OF GUIDELINE FOR REGISTRATION OF DRUG-MEDICAL DEVICE   AND MEDICAL DEVICE-DRUG COMBINATIONS PRODUCTS

 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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