For the C and D classes of devices, the manufacturing site shall be inspected within a period of 60 days from the application to verify QMS compliance. Subsequent to this, an inspection report shall be issue with recommendations and observations, based on which the government shall approve or reject the license of a given product within 45 days. This procedure is similar to the one that exists in the Europe. Furthermore, all the devices are required to conform their performance standards set by the BIS or ISO or IEC or any other pharmacopoeial standard. The safety of a medical device is generally demonstrated through a set of biological tests to say that it is “biocompatible”. These are in vitro and/or in vivo tests that are carried out in accordance with international standards (ISO 10993). Very few laboratories in India are proficient in conducting biocompatibility tests for medical devices. However, this expertise can certainly be expanded.

With respect to the registration of the medical devices, all approvals are time bound so that innovative products are brought to the market to reach the patients promptly and those that do not comply are given a chance to improve and get qualified. The license, once issued for a device, is permanent, however, a renewal fee must be paid every five years to keep the license active, failing which the license may stand cancelled. Any changes in the material of construction, design affecting quality, intended use or indications for use, performance, stability, sterilization method, shelf life, domestic manufacturer name or site are to be submitted for approval by the licensing authority. Minor changes are to be notified to the authority within 30 days of implementation. In addition, clinical investigations require prior approval according to the new MDR. Importing or manufacturing investigational medical devices for conducting clinical trials require prior approval from the authority.

The medical device industry is included in the “Make in India” campaign. This will open up new business avenues and lure Foreign Direct Investment up to 100% through the automatic route. Proposals for financing common facilities and prioritizing domestic manufacturers as the first choice of sourcing medical devices by government agencies are underway. These moves are encouraging and many medical device manufacturers have begun their exploration on this, however, import duties would still be a bottleneck.

It is evident that there is a long agenda for the Indian Government in the medical device sector and it certainly involves a lot of time and resources. Given the infancy of the MDR 2017, the corporate master plays in this market cannot be totally eliminated, however, it is certainly a beginning of an end to this unpalatable medical tourism. No wonder, we are still toddling in this industry as far as our regulations are concerned. Nevertheless, it is a brave move that is worth appreciating! While preventing the diseases is the core objective of any country, preparing a battalion for any catastrophe is what a country does and in the case of medicine, the making of good quality medical devices – the battalion – is the biggest challenge. On an optimistic note, these new regulations will upgrade the quality of the medical devices. Hopefully, this move will take India towards betterment in the medical device industry, providing safe and efficacious devices in the near future.