ARTICLE SUMMARY:
The International Medical Device Regulators Forum accepts new members and approves new guides. Excerpted from Pathways’ Picks October 9: TCET Tricuspid Valve Tryout, EtO Actions, IMDRF Updates, and More.
Eight new device regulatory agencies from Africa, the Middle East, Southeast Asia, and Latin America have joined the International Medical Device Regulator Forum as affiliate members. IMDRF approved the agencies at its meeting last month in Seattle and announced the entries last week, along with acceptance of the Saudi Food and Drug Authority as an IMDRF “official observer.” Affiliate membership, which allows participation in open IMDRF forums and working groups, is intended to help countries build new or more robust device regulatory frameworks with the support of other IMDRF members. One of the new affiliates, India’s Central Drugs Standard Control Organization, cited legislation pending in India that would, for the first time, establish a distinct legal authority to regulate devices separate from drugs in the country. Alongside that effort, CDSCO said October 3, the link with IMDRF will strengthen India’s regulatory system, “helping meet emerging technical challenges that are increasingly diverse, to ensure protection of public health and safety, and continue to maintain the goal of international recognition for its Medical Device regulation.” The other new members are:
- BOMRA (Botswana)
- Ministry of Health (Costa Rica)
- DIGEMAPS (Dominican Republic)
- Medical Device Control Department (Oman)
- DINAVISA (Paraguay)
- DIGEMID (Peru)
- MCAZ (Zimbabwe)