India’s New Medical Device Rules Launched on Schedule

On January 1, 2018 the Indian government launched the Medical Device Rules as planned. The on-line SUGAM system has been converted and will now only process medical and IVD device applications under the new Rules.

All applications for product registration under the old Rules have been cleared from the system. Pending applications that were not fully processed before December 31st must now be submitted as a fresh submission under the new Medical Device Rules, 2017.

Product Registration Certificates (Form 41) or Import Licenses (Form 10) issued under the Act will be deemed valid until their expiry date or July 31, 2018 whichever is later. The DCGI does not intend to issue new Form 10 Import Licenses going forward.

Contact Asia Actual to look up the status of your medical or IVD device licenses under the old Act; or to submit new applications under the new Rules.

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