India Plans to Bring All Medical Devices Under CDSCO Oversight in December
The Indian government is planning to give the Central Drugs Standard Control Organization (CDSCO) oversight of the import, manufacture and sale of all medical devices in December. If finalized, the change would require many more medical device companies to seek certification and authorization. India has been slowly bringing more medical devices under the drugs rules in recent years, starting with high-end products such as imaging equipment. In April, the Drugs Technical Advisory Board (DTAB) signed off on a major expansion of the move to treating devices as drugs, drafting legislation that would require companies that import, make and sell products including contraceptives and certain disinfectants to seek certification and authorization from the national regulator. The Indian government recently published the draft legislation created by DTAB. The draft is open for comment for 30 days, but the government expects to take little time to review the feedback. Under the current plan, the...
