This blog post is a summary of an article that I have co-authored for MedDevice Online, regarding a 108-page notification published by Prime Minister Narendra Modi’s Ministry of Health in India, covering the regulation of the manufacture, sale, and possible recall of virtually all kinds of medical devices, whether imported or domestic.
- Device licenses now will be granted in perpetuity, not just for three-year terms.
- The manufacturer simply has to pay a renewal fee every five years if the product still is being marketed.
- For imported devices, the approval or rejection will take a predictable maximum of nine months; device registration will automatically imply an import license, without the need to wait an additional three months for the import license.
- Multiple devices produced at the same factory can now be included in a single application, and the application must be filed completely online.
- There is a proactive time commitment in the regulations. If the regulatory authority fails to complete the process within the specified time, a license shall be “deemed” to have been approved; this is a novel concept in Indian bureaucracy.
Professional companies from both India and the West, overall welcome the implementation of standards-based design and manufacture of devices, and general manager of Bloomington, Indiana-based Cook Medical in Chennai, Vijayan Govindaraman, calls the new rules “a positive step by the government to a long-standing demand by industry to frame separate regulations for medical devices.”
Both my co-author Rajnish Rohatgi and I think that device companies and patient advocates have much to celebrate. We expect that the Indian government will encourage foreign companies to leverage local manufacturing opportunities. To that end, it may make sense for Western companies to start looking at greenfield manufacturing in India; others may wish to buy and bolster small and medium-sized Indian companies, who will appreciate the global expertise in building up their own capabilities.