In this week’s roundup: Looking to a comprehensive regulatory reform plan in India; important IVDR updates in the EU; and FDA has a busy classification week for diagnostics, including for HIV and HCV tests; also news from China, Italy, and Brazil.
[Editor’s note: Pathways’ Picks posted one day early this week due to the US Thanksgiving holiday.]
What we’re watching for:
India reform report? A government-commissioned panel tasked with proposing fundamental reforms to India’s drug, device, and cosmetic law is slated to issue a draft report on November 30. It’s not clear if the report will be public, but it could be a catalyst for deepening near-term discussions for establishing distinct statutes and distinct regulators for medical devices in the country. The Indian government has established more bespoke rules for devices during the past four years and is rolling out risk-based registration requirements covering all devices over the next few years, along with hiring more device experts. But those changes have all been carried out under India’s 80-year-old drug and cosmetic law that doesn’t directly address devices. The panel is tasked with coming up with a plan to modernize the law, and industry supports including device-specific laws and resources in the mix.