What is the MD-41/42 Wholesale License in India?

The MD-41/42 license is an official authorization issued under the Medical Device Rules, 2017 (MDR 2017) by the Central Drugs Standard Control Organisation (CDSCO) through the State Licensing Authority (SLA).

• MD-41 → Application for the Wholesale license (distribution to stockists, distributors, or exhibitors).
• MD-42 → Wholesale license (distribution to stockists, distributors, or exhibitors).

This license ensures that businesses selling or distributing medical devices comply with CDSCO’s regulatory standards.

Who Needs to Apply for an MD-41/42 License?

The license is mandatory for:

• Stockists managing bulk inventories of medcial devices and In-Vitro Diagnostics.
• Wholesalers purchasing medcial devices and In-Vitro Diagnostics from manufacturers and supplying to retailers or hospitals.
• Exhibitors showcasing devices at trade fairs or exhibitions.
• Importers and foreign companies selling medcial devices and In-Vitro Diagnostics in India (through local representatives).

Without MD-41/42, it is illegal to operate in India’s medcial devices and In-Vitro Diagnostics distribution market.

What Documents Are Required for MD-41/42 License Application?

Applicants need to prepare the following documents:

• Applicant / Firm details with constitution & ID proof (Aadhar/PAN)
• Proof of premises ownership/lease/rental
• Competent technical staff qualifications & experience
• Description of other business activities at premises
• Self-certificate for Good Distribution Compliance (GDC)
• Undertaking on storage requirements compliance
• Additional docs (GST, Trade License, Premises Plan, etc.)
• Prescribed Fees (as per Second Schedule)
• Legal Form of business entity
• Device classification details (Class A, B, C, D).

What is the Process of Obtaining the MD-41/42 License?

The application is filed online via the CDSCO portal. Steps include:

1. Register on the portal.
2. Fill out the wholesale license application form.
3. Upload required documents.
4. Pay the government fee of Rupees 3000.
5. Wait for CDSCO/SLA review and inspection.
6. Receive approval and license (Form MD-42).

How Long Does It Take to Get an MD-41/42 License?

The timeline is usually 10 days, depending on:

• Accuracy of submitted documents.
• Response time during clarifications.
• Completion of inspections by the SLA.

How Long is the MD-41/42 License Valid?

The license is issued in Form MD-42 and remains valid for five years. Businesses must apply for renewal before expiry to avoid penalties.

How Can I Renew My MD-41/42 License?

The renewal process includes:

1. Visit the CDSCO portal.
2. Submit the renewal application online.
3. Pay the required renewal fee.
4. Wait for CDSCO review.
5. Receive updated license approval.

Why is the MD-41/42 License Important for Businesses?

The license ensures:

• Legal authorization for selling and distributing Medcial Devices and In-Vitro Diagnostics.
• Higher credibility with hospitals and dealers.
• Compliance with CDSCO regulations.
• Access to government tenders and institutional sales.

Without it, businesses face heavy penalties and loss of market trust.

What Are the Penalties for Operating Without an MD-41/42 License?

Businesses found operating without a valid license may face:

• Large monetary fines.
• Suspension of operations.
• Cancellation of business activities.
• Criminal proceedings under MDR, 2017.

How Can I Check the Status of My MD-41/42 Application?

To track your application:

1. Visit the CDSCO official website.
2. Go to the "Application Status" section.
3. Enter your application/file number.
4. Authenticate via OTP (email or phone).
5. View current application progress.

What If I Need to Modify My MD-41/42 License?

If changes are required (like address, business details, or personnel):

• Submit a modification request online to CDSCO.
• Provide necessary supporting documents.
• Wait for CDSCO approval before the change becomes valid.

Can Foreign Companies Apply for an MD-41/42 License?

Yes. Foreign manufacturers can apply if they:

• Appoint a local authorized representative/distributor.
• Submit documents as per CDSCO requirements.
• Follow MDR, 2017 guidelines for wholesale distribution.

How Can Businesses Stay Compliant After Receiving the License?

To remain compliant, businesses should:

• Maintain proper sales and inventory records.
• Conduct regular internal audits.
• Keep staff trained on regulatory guidelines.
• Renew licenses on time.

What is the Final Take on MD-41/42 License?

The MD-41/42 license is a vital compliance requirement for anyone involved in India’s medical device wholesale sector. It not only ensures legal operation but also builds credibility, safety, and long-term growth opportunities.

Partnering with an experienced regulatory consultancy makes the process faster, smoother, and risk-free.

How Can Satori One Click Solution Help You With MD-41/42?

At Satori One Click Solution LLP, we specialize in regulatory compliance, licensing, and approvals for pharmaceuticals and medical devices. Our experts simplify the MD-41/42 application process by:

• Reviewing documentation.
• Filing applications online.
• Handling compliance checks.
• Ensuring faster approvals.

With offices in India, USA, and Canada, and global alliances, we help businesses expand confidently in regulated markets.

Contact us today: satoriocs@gmail.com