MEDICAL DEVICES REGULATORY SERVICES
Presently, the regulations for Medical Devices in India are still evolving. Only a select few products need a medical device permission to be launched. In the past few years, there have been three major announcements outlining the medical device products that need to be registered.
Up to 2005, only medical devices such as disposable hypodermic syringes, condoms, tubal rings, metered dose inhalers (MDIs), etc., had to be registered in India. Beginning March 1, 2006, items such as cardiac stents, catheters, intraocular lenses, bone cement, drug eluting stents, also must be registered for import, manufacture and sale. Further, on March 20, 2009, the Central Drugs Standard Control Organization (CDSCO) ratified that sterile medical equipments such as spinal needles, extension tubes, insulin syringes, endotracheal tubes, and cardiac patches must also be registered.