How to Get an MD 42 License in India?

Introduction of MD 42 Registration

The MD-42 license is an important requirement for businesses that stock, show, or distribute medical devices in India. The Drugs and Cosmetics Act of 1940 and the Medical Devices Rules of 2017 govern this license. It makes sure that medical device distributors follow the quality and safety rules. The Central Drugs Standard Control Organization (CDSCO) sets these rules.

With India’s rapidly growing medical device industry, obtaining an MD-42 registration certificate has become essential for manufacturers, wholesalers, and distributors. This blog gives a clear, step-by-step guide on how to get the license. It covers eligibility, required documents, fees, and the approval process.

What is an MD 42 License?

The MD-42 license is a legal permit given by the State Licensing Authority (SLA). This authority is part of the Ministry of Health and Family Welfare (MoHFW). It permits businesses to engage in the following activities related to medical devices:

• Stocking – Storing medical devices in compliance with prescribed storage conditions.
• Exhibiting for Sale – Displaying medical devices for commercial purposes.
• Distributing – Supplying medical devices to retailers, hospitals, and other healthcare providers. This license is mandatory under Form MD-42 for dealers, wholesalers, and distributors of notified medical devices in India. Non-compliance can lead to heavy penalties, seizure of products, or even legal action.

Eligibility Criteria for MD-42 License

To apply for an MD-42 registration certificate, the applicant must meet the following requirements:

• Business Registration – The applicant must be a legally registered entity (Proprietorship, Partnership, LLP, Private Limited Company, etc.) with valid GST and PAN.
• Premises Compliance – The business location must have proper storage facilities as per CDSCO guidelines, including temperature control (if required).
• Qualified Personnel – The firm should employ personnel with relevant qualifications (e.g., a pharmacist or technical expert) to ensure compliance.
• Manufacturer Authorization (if applicable) – Distributors must submit an authorization letter from the medical device manufacturer.

Documents Required for MD-42 License Application

The following documents must be submitted along with Form MD-41 for a successful application:

• Business Proof – Certificate of Incorporation, Partnership Deed, or GST Registration.
• Address Proof – Rental agreement or property papers of the business premises.
• Medical Device Registration Certificate – Required if dealing with notified medical devices (Class A, B, C, or D).
• Manufacturer Authorization Letter – Needed for distributors to prove legitimacy of supplied products.
• Affidavit of Compliance – A self-declaration stating adherence to Medical Devices Rules, 2017.
• Key Personnel Details – Educational and experience certificates of responsible personnel.
• Site Master File – A document outlining storage and handling procedures.

Step-by-Step Process to Obtain MD-42 License

Step 1: Submission of Application (Form MD-41)

• The applicant must fill out Form MD-41, available on the CDSCO portal or respective State Drug Control Department website.
• You must attach all required documents in the prescribed format.

Step 2: Payment of Application Fees

• The MD-42 license fee varies depending on the state and business type (wholesale, retail, or distribution).
• You can make payment online via the CDSCO portal or through designated banks.

Step 3: Inspection by State Licensing Authority (SLA)

• After submission, the SLA conducts a physical inspection of the business premises.
• Authorities verify storage conditions, record-keeping systems, and compliance with quality standards.

Step 4: Approval & Issuance of MD 42 License

• If the inspection succeeds, the authorities issue the MD 42 registration certificate within 30-45 days.
• The authorities grant the license for 5 years, and you must renew it before it expires.

Key Regulations Under Medical Device Rules, 2017

Businesses holding an MD-42 license must comply with the following regulations:

• Labeling Requirements – Medical devices must have proper labeling with manufacturer details, expiry date, and storage conditions.
• Record Maintenance – Distributors must maintain records of sales, purchases, and product recalls (if applicable).
• Quality Compliance – Products must meet ISO 13485 or other relevant quality certifications.
• Import Regulations – Imported medical devices require additional approvals from CDSCO.

Why is the MD-42 License Important?

• Legal Compliance – Ensures adherence to Drugs and Cosmetics Act, 1940, avoiding legal penalties.
• Business Credibility – Builds trust with manufacturers, hospitals, and regulatory bodies.
• Smooth Operations – Prevents disruptions because of regulatory non-compliance.
• Market Expansion – Allows businesses to legally distribute medical devices across India.

Conclusion

Obtaining an MD-42 license in India is a mandatory requirement for businesses involved in the medical device supply chain. The process involves documentation, inspection, and compliance with CDSCO regulations. To ensure a hassle-free and quick approval, PSR Compliance is the best consulting partner. With years of experience in medical device licensing, we offer complete support. This includes document preparation and working with SLAs. Contact PSR Compliance today and secure your MD-42 license without delays!