Snapshot

The IVD Registration (India) pathway has been developed by the of India.

This pathway can be used where Pre-consultation with the regulatory authority is available on an optional basis. Manufacturers of new or non-notified medical devices may request clarification regarding their product’s regulatory status and classification prior to formal filing with the CDSCO. Filing Portal & Official Contact Submission Portal: Applications and regulatory filings are processed via the National Single Window System (NSWS) Portal (effective January 2024). General Inquiries: Questions regarding submissions, application statuses, and approvals can be directed to the Drugs Controller General of India (DCGI). Contact Information: Authority: Central Drugs Standard Control Organisation (CDSCO) Address: FDA Bhawan, ITO, Kotla Road, New Delhi – 110002, India Email: dci@nic.in Phone: +91-11-23236965 / +91-11-23236975 Fax: +91-11-23236973 .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Import License (MD-15): 9 months. An Import License (Form MD-15) remains valid indefinitely unless it is suspended or canceled, provided the license holder pays the prescribed retention fee—as specified in the Second Schedule—to the Central Licensing Authority every five years from the date of issuance..