🏥MD-42 Registration Certificate for Medical Devices in India

What is MD-42?

The MD-42 Registration Certificate is a mandatory authorization issued by the State Licensing Authority (SLA) under the Medical Device Rules, 2017. It permits entities to sell, stock, exhibit, or distribute medical devices, including in-vitro diagnostic devices, within India.

This certificate ensures that businesses comply with regulatory standards, thereby safeguarding public health and maintaining the integrity of the medical device supply chain.

 Who Requires MD-42?

The MD-42 certificate is essential for:

  • Retailers of medical devices

  • Wholesalers and distributors

  • Stockists and exhibitors

  • Importers intending to sell medical devices in India

Note: Manufacturers of Class A and B medical devices also require MD-42 to legally market their products in the country.

MD-42 Documentation

🛠️ Application Process

  1. Form Submission: Complete and submit Form MD-41 to the respective State Licensing Authority via the CDSCO SUGAM portal.

  2. Document Upload: Provide all necessary documentation (see below).

  3. Fee Payment: Pay the prescribed fee of ₹3,000.

  4. Review & Inspection: The SLA reviews the application and may conduct a site inspection.

  5. Certificate Issuance: Upon approval, the MD-42 certificate is granted.

📄 Required Documents

  • Business Registration Proof: Company incorporation certificate or partnership deed.

  • Premises Proof: Rent agreement or property ownership documents.

  • Identity Proof: PAN card or Aadhaar card of the applicant.

  • GST Registration Certificate.

  • Competent Technical Staff (CTS):

    • Qualification certificates (degree/diploma).

    • Experience letter (minimum one year in medical device sales).

  • Self-Declaration: Compliance with Good Distribution Practices.

  • Site Plan: Layout of the storage premises.

  • Undertaking: Assurance of proper storage conditions.

📆 Validity & Renewal

  • Validity: The MD-42 certificate remains valid in perpetuity, subject to payment of a retention fee every five years.

  • Renewal: Ensure timely payment of the retention fee to avoid suspension or cancellation.

⚠️ Compliance Obligations

Holders of the MD-42 certificate must:

  • Display the certificate prominently at their premises.

  • Maintain adequate storage conditions, including temperature and lighting.

  • Source medical devices only from licensed manufacturers or importers.

  • Keep Records: Detailed logs of purchases and sales, including batch numbers and expiry dates.

  • Facilitate Inspections: Allow authorized officers to inspect premises and records.

  • Maintain an Inspection Book: As per Form MD-43 for recording observations.

🛒 E-Commerce & MD-42

Major e-commerce platforms like Amazon and Flipkart mandate sellers of medical devices to possess a valid MD-42 certificate. This ensures that only compliant and safe devices are available to consumers.

🤝 How Zensen Ventures Can Assist

At Zensen Ventures, we offer end-to-end support for obtaining your MD-42 certificate:

  • Eligibility Assessment: Determine if your business requires MD-42.

  • Documentation Assistance: Help in gathering and preparing necessary documents.

  • Application Filing: Submit Form MD-41 on your behalf.

  • Liaison with Authorities: Coordinate with the SLA throughout the process.

  • Post-Certification Support: Guidance on compliance and renewals.

Contact us today to ensure your business remains compliant and operational.

📞 Phone: +91 9600 521 721
🌐 Website: www.zensenventures.in
💬 WhatsApp: +91 9600 521 721

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