The Association of Indian Medical Device Industry (AIMED) recently established a new program called the Indian Certification of Medical Devices Scheme (ICMED). Previously, there was no specific quality assurance system in India. This new scheme will standardize the level of quality for medical devices, enhance product safety, and boost the credentials of Indian medical device companies. Additionally, regulators hope that this scheme will shorten the time it takes for Indian medical devices to receive approval in foreign markets.
There are currently two different certification options under the ICMED system. The ICMED 9000 Certification is similar to an ISO 9001, and the ICMED 13485 is similar to an ISO 13485. Both of these certifications have additional requirements that Indian device manufacturers will have to meet in order to receive approval.