MDR CDSCO Registration

Who Needs This Service

Medical device manufacturers, importers, brand owners using loan licences, foreign manufacturers using Indian authorised agents and sellers of devices need MDR licensing.

Startups developing devices should classify early.

Importers must have MD-42 holders as agents.

If your product is a drug or cosmetic, other rules apply.

Key Benefits

• Clear classification and route
• Documents and DMF prepared
• Portal filing
• Retention fee reminders
• Reduced regulatory risk

Next Steps & Related Services

After licensing, comply with post-market duties. Related services: MD-15, MD-5, MD-9, MD-42, loan licences and IVD registration.

Common Mistakes

• Wrong classification.
• Missing DMF.
• No MD-42 agent for imports.
• Missing retention fee.
• Selling before licence.

Timeline, Costs & Practical Tips

Timelines vary by class.

Practical tip: build the Device Master File early.

Additional Information

MDR 2017 brought medical devices under a dedicated regulatory regime.

Practical Scenarios

Scenario 1:

A syringe maker licenses.

Scenario 2:

An importer applies.

Scenario 3:

A startup classifies its device.

Process & Planning

Start your medical device plan with classification. Use CDSCO's lists to place the device in Class A, B, C or D, then choose the route: manufacture (MD-3 or MD-7), loan licence (MD-4 or MD-8) or import (MD-14 with an MD-42 holder as agent). Prepare the Device Master File, labelling, instructions for use, quality documents and entity details, register on the CDSCO medical device portal and file with fees. The State or Central Licensing Authority scrutinises, inspects where required and grants the licence, which stays perpetual with a retention fee every five years. Planning checklist: build the DMF early, decide whether you need clinical or performance data, appoint an Indian agent for imports, track retention fee dates and monitor CDSCO circulars.