Harmonization and International Collaborations
TMDA’s medical devices regulatory frame work is based on the proposals of the pioneering harmonization initiatives such as Global Harmonization Task Force (‘GHTF) current International Medical Devices Regulators Forum (IMDRF). Through these initiatives the following requirements were adopted:
- Requirements for compilation of technical file (dossier) for submission to regulatory authority for market Authorization.
- Requirements for Manufacturer to comply with specification and principles of International Standards for Standardization (ISO) or its equivalent.
- Method of grading non-conformity observed during quality audit of medical devices manufacturing facility.
- Evidence of conformity to essential principles of safety and performance of medical devices and In-vitro diagnostic devices.
- TMDA is a sitting member of African Medical Devices Regulator Forum (AMDRF), a platform that regulators of Africa that aims at creating requirements for regulation of medical devices and in-vitro diagnostic devices that will be uniform in all African countries, considering the benefits of harmonization.
- TMDA is an observer in the Pan Asian Harmonization Working Party (PAHWP), and has representatives in several technical working groups in PAHWP
- TMDA is the member of World Health Organization (WHO) and has participated in the pilot phase of the Corroborative Registration Procedures (CRP) for Invitro diagnostic devices, which gives a provision of minimum/no duplication of work while ensuring accessibility of safe, quality and effective medical devices and In-vitro diagnostic devices. More information link to WHO Invitro diagnostic CRP
- Omission of confusion to investors who are interested in establishing medical devices and Invitro diagnostic devices in the region, since they will be familiar with regulatory requirements
- Increased number of submissions of application of registration of product in the country because manufacturer would submit same dossier submitted globally to be approve and ensure accessibility of quality products.
- Removing redundant requirements and retaining and adapting critical requirements in order to have uniform acceptable international requirements.