CONFORMITY ASSESSMENT PROCEDURES FOR MEDICAL DEVICE APPROVED BY RECOGNISED COUNTRIES

 

This Circular Letter was prepared by the Medical Device Authority (MDA) to facilitate the stakeholders and industries in the implementation of Medical Device Act 2012 (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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