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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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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Last Modified: 25 February 2020.
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