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: