This is the latest gazettement of the Medical Device Regulations pursuant to the Medical Device Act 2012 (Act 737). The gazettement 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 above-mentioned requirement in order to safeguard interest with the oncoming of the mandatory phase very soon.
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 the postmarketing activity of medical devices.
To access Medical Device (Advertising) Regulations 2019, please download ATTACHMENT 1.
To access Medical Device (Duties and Obligations of Establishments) Regulations 2019, please download ATTACHMENT 2.
Source : MDA Malaysia
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