Form MD-9 (Manufacturing License)

Who Needs This Service

Manufacturers of higher-risk devices such as implants, ventilators, infusion pumps and IVD kits (Class C and D) need MD-9.

Companies scaling from Class B to C need to upgrade.

Brands outsourcing manufacturing can use MD-10 loan licence.

If your device is Class A or B, use MD-5.

Key Benefits

• Legal manufacturing of higher-risk devices
• DMF and QMS prepared
• Clinical data guidance
• CDSCO audit readiness
• Perpetual validity

Next Steps & Related Services

After MD-9, maintain QMS and report. Related services: MD-5, MD-10, MD-15 and IVD registration.

Common Mistakes

• Weak clinical evidence.
• Incomplete QMS.
• Wrong classification.
• Skipping audit prep.
• Unpaid retention fee.

Timeline, Costs & Practical Tips

Timelines depend on CDSCO.

Practical tip: prepare risk management and validation records early.

Additional Information

MDR 2017 applies stricter controls to higher-risk devices.

Practical Scenarios

Scenario 1:

An implant maker applies.

Scenario 2:

A ventilator maker applies.

Scenario 3:

An IVD maker applies.

Process & Planning

An MD-9 plan is heavier because Class C and D devices carry higher risk. Build a complete Device Master File, risk management file, quality management system (such as ISO 13485) and validation records, and assemble clinical or performance evidence where needed. File Form MD-7 with the Central Licensing Authority, prepare for audit and inspection and answer queries promptly. Planning checklist: invest early in quality systems, plan time for clinical data, train staff, keep labelling and instructions consistent with the DMF and track the retention fee under CDSCO's circular of 15 May 2024.