✅ What is an MD-42 License?

An MD-42 License is an official authorization issued to medical device distributors or sellers in India. It permits the sale, stocking, exhibition, and distribution of notified medical devices classified under various categories as per Indian regulations.

Without this license, dealing in such medical devices is illegal and can attract penalties or prosecution.

✅ Who Needs an MD-42 License?

You need this license if you:

✔ Sell or distribute Class A and B medical devices
✔ Stock medical devices for sale or distribution
✔ Operate as an importer or wholesaler of medical devices

Examples include:

1. Surgical equipment distributors

2. Medical device wholesalers

3. Diagnostic kit suppliers

✅ Key Requirements and Eligibility

To apply for an MD-42 License, you must:

✅ Have a qualified competent technical staff (minimum qualification: Diploma or Degree in Pharmacy or Science)
✅ Maintain suitable storage facilities with adequate space, lighting, and equipment
✅ Comply with the Medical Devices Rules, 2017 provisions

✅ Documents Required for MD-42 License

Here is a list of the main documents needed:

1. Duly filled Form MD-42 application

2. Declaration of compliance with regulatory requirements

3. Site plan and layout of the premises

4. Proof of ownership/rental agreement of premises

5. Details and qualification certificates of technical staff

6. Affidavit for compliance and non-conviction

7. Undertaking of storage requirements compliance

8. PAN card and identity proof of the applicant

Additional documents may be requested during the review process.

✅ How to Apply for MD-42 License

Follow these steps to get your license:

1️⃣ Prepare and collect all required documents.
2️⃣ Register on the CDSCO SUGAM portal.
3️⃣ Submit your application in Form MD-42 along with the prescribed fees.
4️⃣ The regulatory authority will review your documents and inspect your premises.
5️⃣ If all conditions are met, the MD-42 License will be granted in Form MD-43.

✅ Why Is an MD-42 License Important?

Having an MD-42 License ensures:

✅ Full legal compliance under Indian medical device laws
✅ Smooth operation of your distribution business
✅ Enhanced credibility and trust among customers and stakeholders
✅ Avoidance of heavy penalties and business interruption

✅ How PSR Compliance Can Help

At PSR Compliance, we provide complete assistance in:

✔ Document preparation
✔ Online application filing on the CDSCO portal
✔ Liaison with authorities
✔ Resolving queries and ensuring smooth approval

For more details about the MD-42 License and professional help with your registration process, visit:
👉 https://www.psrcompliance.com/md-42-license