The Drugs Technical Advisory Board, an entity that provides advice to India’s government on issues related to pharmaceuticals and medical devices, agreed upon changes to the country’s Drugs and Cosmetic Rules that would add more specific quality system requirements for domestic medical device manufacturers. It also agreed to add endometrial ablation devices, and “Disposable Perfusion Sets” such as heart lung packs, custom tubing and perfusion packs to the list of notified devices subject to regulation by the Indian Central Drugs Standard Control Organization, reports Emergo.
The quality system proposal, called Schedule M-III by the Drugs Technical Advisory Board, would apply to manufacturers of medical devices as well as IVD reagents and kits. The schedule lists requirements in the following areas:
- Design and Development
- Manufacturer
- Packaging
- Labeling
- Testing,
- Installation and Servicing
Quality Management Systems would apply to the following device types:
- Finished Medical Devices
- IVD Products
- Mechanical Contraceptives
- Surgical Bandages, Dressings, Staplers, Sutures and Ligatures
- Blood and Blood Component Collection Bags
The quality management proposals will apply only to devices “notified” with the Indian Central Drugs Standard Control Organization.
