Form MD-6 (Loan License)

Who Needs This Service

Startups and brand owners who outsource manufacturing of low-risk medical devices to contract manufacturers need MD-6.

Companies launching new devices without a plant benefit.

Hosts must hold valid MD-5.

If you want to own production, apply for MD-5.

Key Benefits

• Brand launch without owning a plant
• Host agreement and documents prepared
• Portal filing
• Perpetual validity with retention
• Quality responsibility clarity

Next Steps & Related Services

After MD-6, manage quality with the host. Related services: MD-5, MD-10, MD-42 and MDR registration.

Common Mistakes

• Weak host agreement.
• Host licence not valid.
• Missing labelling.
• Unclear responsibility.
• Unpaid retention fee.

Timeline, Costs & Practical Tips

Timelines depend on SLA.

Practical tip: confirm host licence validity.

Additional Information

MDR 2017 allows loan licensing with shared responsibility.

Practical Scenarios

Scenario 1:

A brand outsources dressings.

Scenario 2:

A startup outsources thermometers.

Scenario 3:

A company adds devices.

Process & Planning

To obtain an MD-6 loan licence, first choose a host manufacturer with a valid MD-5 licence for the devices you want to make, and sign a clear manufacturing agreement covering quality, labelling, responsibilities and changes. Prepare your constitution documents, device list, labelling, instructions for use and quality arrangements, then file Form MD-4 on the CDSCO portal with fees. Planning checklist: verify the host's licence status, define who handles complaints and recalls, keep both parties' documents aligned and diarise the retention fee.