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  • MEDICAL DEVICE (ADVERTISING) REGULATIONS 2019 AND MEDICAL DEVICE (DUTIES AND OBLIGATIONS OF ESTABLISHMENTS) REGULATIONS 2019

MEDICAL DEVICE (ADVERTISING) REGULATIONS 2019 AND MEDICAL DEVICE (DUTIES AND OBLIGATIONS OF ESTABLISHMENTS) REGULATIONS 2019

1. This is a notification on the latest gazettements of the Medical Device Regulations pursuant to the Medical Device Act 2012 (Act 737). The gazettements took effect on 3rd September 2019. However the Regulations will only come into operation on 1st July 2020 to allow stakeholders adequate time to comply with all the requirements. As to that effect, the Medical Device Authority encourages compliance by the stakeholders to submit to the abovementioned requirement in order to safeguard interest with the oncoming of the mandatory phase very soon.

2. The Medical Device (Advertising) Regulations 2019 prescribes the matters relating to the contents of and conditions for advertising of medical devices. Meanwhile, the Medical Device (Duties and Obligations of Establishments) Regulations 2019 prescribes the manner, criteria, conditions and procedures of postmarketing activity of medical devices.

3. For any enquiries and updates on the regulatory requirement, you may visit MDA's official portal at portal.mda.gov.my.

4. For the regulations, Please click down here:

 - Medical Device (Advertising) Regulations 2019

 -  Medical Device Duties and Obligations of Establishments 

Thank You. 

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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: 30 September 2020.
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