Form MD-5 (Manufacturing License)

Who Needs This Service

Domestic manufacturers of Class A and B devices such as dressings, syringes, thermometers, gloves and stethoscopes need MD-5.

Startups with a small production unit should plan facility and staff.

Brands using contract manufacturers can use loan licences.

Class C and D manufacturers need MD-9.

Key Benefits

• Legal manufacturing of low-risk devices
• Documents and DMF prepared
• Inspection readiness
• Portal filing
• Perpetual validity with retention

Next Steps & Related Services

After MD-5, maintain QMS. Related services: MD-9, MD-6, MD-15 and MDR registration.

Common Mistakes

• Wrong class.
• Weak facility.
• Missing staff qualifications.
• Incomplete DMF.
• Unpaid retention fee.

Timeline, Costs & Practical Tips

Timelines depend on SLA inspection.

Practical tip: prepare premises and QMS before filing.

Additional Information

MDR 2017 requires manufacturing licences for devices to ensure quality.

Practical Scenarios

Scenario 1:

A glove maker applies.

Scenario 2:

A thermometer maker applies.

Scenario 3:

A startup builds a facility.

Process & Planning

To get an MD-5 licence, start with the premises and the quality system. Make sure the site, equipment and testing facilities suit Class A or B devices, appoint qualified technical staff and prepare the Device Master File, manufacturing process description, labelling and instructions for use. File Form MD-3 on the CDSCO portal for the State Licensing Authority with fees, prepare for inspection and respond to queries. Planning checklist: keep premises ownership or lease documents ready, document staff qualifications, run a mock audit before inspection, and diarise the retention fee due before each five-year period ends.