The Medical Device (Duties and Obligations) Regulations 2019 or better known as 2019 Regulations outlines each establishment's post-market responsibilities in compliance with the Medical Devices Act 2012, under Section 37 to Section 42 regulations. All licensed establishments and those with registered medical devices must fulfill this responsibility.
The following are the major points of this 2019 Regulation and the necessary reference guidelines:
- 1. Regulation 2019 (Regulation 2019)
- 2. Distribution records
- 3. Complaint handling record
- 4. Mandatory problem reporting
- 5. Field Corrective Action (FCA)
- 6. Medical Device Recall
As we all know, the registration of medical devices regulated since 2012, when Act 737 was publicly gazette. MDA will not compromise on any establishment that does not meet its post-market requirements and responsibilities once the 2019 Regulation is implemented. If there are violations of Act 737 and 2019 Regulation, MDA may revoke and canceled the establishment license and certificate of the medical device. The establishments that violate the law may also prosecute in court.
Starting July 1, 2022, MDA will effectively enforce the Medical Devices (Establishment Duties and Obligations) Regulations 2019. All relevant establishments are advised to keep themselves updated according to the regulation specified, in order to avoid any penalties.
Medical Device (Duties and Obligations of Establishment) Regulations 2019
Guidance Documents Distribution Records
Guidance Documents Complaint Handling
Guidance Documents Mandatory problem reporting
Guidance Documents Field Corrective Action (FCA)
Guidance Documents Medical Device Recall