CIRCULAR LETTER OF THE MEDICAL DEVICE AUTHORITY NO. 1 YEAR 2019 (REVISION 1) POST-MARKET RESPONSIBILITIES FOR MANUFACTURER AND AUTHORIZED REPRESENTATIVE (AR)

CIRCULAR LETTER OF THE MEDICAL DEVICE AUTHORITY 1 YEAR 2019 (REVISION 1)

POST-MARKET RESPONSIBILITIES FOR MANUFACTURER AND AUTHORIZED REPRESENTATIVE (AR)

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;

  1. a) Medical Device Act 2012 (Act 737); and
  2. b) Medical Device Regulations 2012;

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