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Ensure smooth operations and regulatory compliance for Class A & B medical devices with Medfins end-to-end MD6 licensing services.
Break down your offerings as a list or grid:
Visual timeline or steps:
| Applicant Type | Application | License |
|---|---|---|
| Manufacturer | Form MD-3 | Form MD-5 |
| Test License | Form MD-12 | Form MD-13 |
| Applicant Type | Application | License |
|---|---|---|
| Manufacturer | Form MD-3 | Form MD-5 |
| Test License | Form MD-12 | Form MD-13 |
Once approved, you can legally manufacture and market Class A or B medical devices through the partnered facility. However, you must maintain regulatory compliance, including product labelling, periodic updates, and retention fee payments.Medfins provides continued support post-license approval.
Yes. If you do not own a manufacturing facility but wish to manufacture Class A or B devices in India, obtaining an MD6 loan license is legally required under the Medical Device Rules (MDR) 2017.
The typical timeline ranges from 3 to 4 months depending on document readiness, regulatory load, and any clarification queries. Medfins helps reduce delays by ensuring complete and compliant submissions from the outset.
The license is valid indefinitely, subject to payment of retention fees every 5 years.
The loan license holder is responsible for regulatory compliance, even though manufacturing is carried out by the third party.
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