MD-42 Registration Certificate in India – Complete Guide for Selling & Importing Medical Devices (2026)

In this guide, we explain:

1. What is Form MD-42?
2. Who needs MD-42 registration?
3. How to apply using Form MD-41
4. Documents required
5. Fees, validity & renewal
6. Compliance requirements
7. Penalties for non-compliance

What is Form MD-42 Registration Certificate?

Form MD-42 is a Registration Certificate issued by the State Licensing Authority (SLA) under the Medical Device Rules, 2017.

It is required for businesses that:

1. Sell medical devices
2. Stock medical devices
3. Exhibit medical devices
4. Distribute medical devices
5. Import medical devices for sale

MD-42 replaced the earlier drug license requirement (Form 20B/21B) for notified medical devices.

Who Needs MD-42 Registration in India?

You must obtain MD-42 if you are:

1. Medical device retailer
2. Medical device wholesaler
3. Distributor or stockist
4. Importer selling directly in India
5. Online seller / e-commerce operator
6. Hospital pharmacy selling medical devices
7. Trading company dealing in notified medical devices

If you deal in Class A, B, C, or D medical devices, MD-42 registration is applicable.

How to Apply for MD-42 Registration Certificate

The application for MD-42 is made online through the CDSCO Portal or offline through submitting the documents to the State FDA Department depending on the location of the premises using Form MD-41.

Step-by-Step MD-42 Application Process (Online):

1. Create login on CDSCO portal
2. Select Form MD-41 (Application for Registration Certificate)
3. Upload required documents
4. Pay prescribed government fee
5. Submit application to State Licensing Authority
6. Inspection (if required)
7. Approval and issuance of Form MD-42

Processing time generally ranges between 15–45 working days, depending on the state.

Documents Required for MD-42 Registration

Here is the complete MD-42 document checklist:

1. Covering letter
2. Constitution documents (GST / PAN / Incorporation Certificate)
3. Premises proof (Ownership / Rent agreement)
4. Layout plan of premises
5. Refrigerator details (if applicable)
6. Appointment letter of competent technical staff
7. Qualification & experience certificates
8. Undertaking & declarations
9. Fee payment challan

Proper documentation ensures faster approval. Any other document required by the department will be intimidated.

Government Fees for MD-42 Registration

Note: Fees may vary if amended by authority.

Validity of MD-42 Certificate

1. MD-42 registration remains valid indefinitely
2. Retention fee must be paid every 5 years
3. Failure to pay retention fee may lead to cancellation

Compliance Conditions for MD-42 Holders

After receiving the MD-42 Registration Certificate, the holder must:

1. Maintain proper purchase and sale records
2. Purchase medical devices only from licensed manufacturers/importers
3. Maintain storage conditions as per manufacturer guidelines
4. Allow inspection by Drug Inspector
5. Inform authority about change in premises or constitution

Non-compliance may lead to suspension or cancellation.

MD-42 vs Drug License (20B/21B)

Many businesses ask:

No.

Earlier, medical devices were regulated under drug licenses (Form 20B/21B). Now, notified medical devices require separate registration under Form MD-42.

Frequently Asked Questions (FAQs)

Yes. E-commerce sellers dealing in medical devices must obtain MD-42.

Yes, if they stock or sell medical devices in India.

Inspection depends on State Licensing Authority discretion.

Generally 3–6 weeks depending on documentation and state.