What is an MD 41 & MD 42 License?

The MD 41 & MD 42 License refers to the regulatory approval required for businesses involved in the wholesale distribution, stocking, or sale of notified medical devices in India.

  • MD 41 is the application form submitted to the State Licensing Authority (SLA) along with required documents and fees.
  • MD 42 is the final wholesale license issued by the SLA after successful verification, document review, and premises inspection.

In short:

  • MD 41 = Application
  • MD 42 = License issued after approval

Why Is It Important To Obtain md-41-md-42-license wholesale?

  • Mandatory license for wholesale and distribution of medical devices in India
  • Ensures full compliance with regulatory requirements
  • Builds credibility with manufacturers, hospitals, and healthcare institutions
  • Avoids penalties, business shutdowns, or legal action
  • Required to participate in government and private tenders

How To Apply For an md-41-md-42-license wholesale?

  • Register on the CDSCO SUGAM portal
  • Submit Form MD 41 with required documents
  • Pay the applicable government fee
  • Site inspection by State Licensing Authority
  • MD 42 License issued upon successful verification

Benefits of the md-41-md-42-license wholesale

  • Legal authorization to distribute medical devices
  • Enhances your business profile in the healthcare supply chain
  • Access to high-value distributors, OEMs, and hospitals
  • Mandatory for operating as a compliant medical device wholesale business
  • Helps build long-term business trust and transparency

Documents Required for the md-41-md-42-license wholesale

  • Constitution of firm (Partnership/Private Ltd/LLP etc.)
  • GST certificate
  • Ownership/rental agreement of premises
  • Layout plan of storage facility
  • Technical staff qualification & experience proof
  • Storage & cold-chain arrangements (if applicable)
  • Undertaking of compliance with medical device rules
  • Authorized signatory ID & Address proof

Why Silvereye Certifications?

  • Expertise in medical device regulatory licensing
  • Complete document preparation & error-proof filing
  • Coordination with State Licensing Authority
  • Faster approval with guided support
  • Pan-India service for MD 41 & MD 42 licensing
  • Post-approval compliance and renewal assistance

Conclusion

Obtaining the MD 41 & MD 42 wholesale license is essential for running a legally compliant medical device distribution business in India. With Silvereye Certifications, the process becomes seamless, transparent, and fully supported at every step.

FAQs for M-D Wholesalers

Any business involved in stocking or wholesale distribution of notified medical devices.

No. MD 41 is the application form. MD 42 is the license issued after approval.

Valid for 5 years unless cancelled or suspended.

Yes, via the CDSCO SUGAM portal.

Yes, the State Licensing Authority inspects the storage premises before approval.

Yes, the md-41-md-42-license wholesale application can be submitted online via the CDSCO SUGAM portal by registering as a wholesale entity dealing in medical devices.

The approval timeline for the md-41-md-42-license wholesale can range from 30 to 60 days, depending on document readiness and inspection scheduling by the State Licensing Authority.

Yes, an appropriate storage facility with proper environmental and safety conditions is required to qualify for the md-41-md-42-license wholesale.

No, the md-41-md-42-license wholesale is state-specific and is only valid in the state where it was issued. A separate license is needed for each state

Without the md-41-md-42-license wholesale, businesses distributing medical devices could face legal penalties, product seizures, and shutdown of operations.