MANILA – The Food and Drug Administration (FDA) has established a technical working group (TWG) to strengthen its regulation of medical devices.
Task Force Obsidian is tasked with the development of clear and comprehensive policies and guidelines for the classification of medical devices submitted for FDA approval.
“Ang kahalagahan po nitong regulation na ito na mapahatid sa kanila [stakeholders] at masabi sa kanila na they have to comply doon sa aming regulation ay pinakamahalaga po para sa amin (This regulation is important in letting them [stakeholders] know that they have to comply with the regulations),“ FDA Spokesperson Pamela Sevilla said on Thursday during a Bagong Pilipinas Ngayon interview.
She said stakeholders usually do not know the classification of their medical device, making them choose not to file an application to the FDA.
In relation to this, the FDA will conduct information dissemination to educate its clients and applicants about regulations related to the ASEAN Medical Device Directive which aims to harmonize medical device regulations, common documents and the progress made in implementation.
The Task Force Obsidian will also assess potential risks in the implementation of these policies and recommend corrective measures to safeguard against non-compliance. (PNA)
