RITM, through its Laboratory Research Division (LRD), led the “Workshop on Developing the Harmonized Process for In-Vitro Diagnostic Medical Devices (IVDMD) Evaluation” for various key partners last August 21-23, 2019 at the Ciudad Christhia Resort, San Mateo, Rizal.
Aiming to develop a standardized end-to-end process for a seamless and efficient IVDMD evaluation, several key partners, namely, Department of Health-Health Facility Development Bureau (DOH-HFDB), Food and Drug Administration Center for Device Regulation-Radiation Health and Research (FDA-CDRRHR), Anti Red Tape Authority (ARTA), and National Reference Laboratories (NRLs) from RITM, Lung Center of the Philippines, National Kidney and Transplant Institute, Philippine Heart Center, and San Lazaro Hospital were convened in the two-day workshop.
According to Ms. Kyria Farinas, RITM LRD Operations unit staff, the objective of the workshop targets a critical process in obtaining an FDA Certificate of Product Registration and the conduct of post-marketing surveillance to ensure that only quality assured diagnostic test kits are available for the safety of the public.
Furthermore, it also takes into consideration the Republic Act No. 11032 also known as “An Act Promoting Ease of Doing Business and Efficiency Delivery of Government Services, amending for the purpose Republic Act No. 9485, Otherwise Known as the Anti-Red Tape Act of 2007, and for Other Purposes”, which declares the policy of the State to establish effective practices aimed at efficient turnaround delivery of government services.
In line with this, DOH and FDA have been working to adopt and implement the ASEAN Agreement on Medical Device Directive (AMDD) Guidelines on the registration of IVDMD, and to develop the local regulatory requirement and registration process related thereto.
“For years, IVDMD development paved way for the influx of diagnostic test kits in the market. These devices aid in the rapid detection of diseases leading to the timely provision of treatment and appropriate patient care,” said Farinas.
by Allenor Enciso, Communication and Engagement Office