Form MD-42 (Sell, Stock, Exhibit)

Who Needs This Service

Distributors, wholesalers, retailers and importers or authorised agents dealing in medical devices need MD-42.

Hospitals and clinics that buy directly may not need it, but suppliers do.

Importers must obtain it before MD-14.

If your premises are not suitable, upgrade before applying.

Key Benefits

• Legal sale and distribution of devices
• Premises and storage documents prepared
• Competent person details
• Pre-condition for MD-15 met
• Portal filing

Next Steps & Related Services

After MD-42, follow record-keeping rules. Related services: MD-15, MDR registration and loan licences.

Common Mistakes

• Inadequate premises.
• No competent person.
• Missing documents.
• Selling before licence.
• Wrong authority.

Timeline, Costs & Practical Tips

Timelines vary.

Practical tip: confirm the issuing authority on the portal.

Additional Information

MDR 2017 regulates sale to ensure proper storage and traceability.

Practical Scenarios

Scenario 1:

A distributor applies.

Scenario 2:

An importer's agent applies.

Scenario 3:

A retailer applies.

Process & Planning

For an MD-42 licence, prepare suitable premises with proper storage, including cold chain where devices need it, and nominate a competent person with the required qualification. Gather constitution documents, PAN, GST, identity of owners or directors, premises proof and layout, then file Form MD-41 on the portal with fees. The licensing authority may inspect. Planning checklist: keep storage records, maintain traceability of devices, check the authority and validity terms on the portal, and obtain MD-42 before applying for MD-15 if you are an import agent.