Medical Devices Covered Under MD-42 License in Bihar

If you manufacture medical devices in Bihar, you may need an MD-42 license. This license is issued by the drug authority under CDSCO rules and is required for certain medical devices notified by the government.

MD-42 is mainly for manufacturers who make medical devices for sale or distribution in India. It confirms that the device meets safety, quality, and regulatory standards.

What Is an MD-42 License?

The MD-42 license is issued to Indian manufacturers of medical devices.
It allows a company to legally manufacture notified medical devices at a specific factory location.

In simple words:

• MD-42 = Manufacturing license for medical devices
• Issued after inspection, document verification, and compliance checks

Medical Devices Covered Under MD-42 License

Not all medical devices need an MD-42 license. Only devices that are notified by the government and fall under regulated categories require it.

Below are common types of medical devices covered:

1. Diagnostic Medical Devices

These devices are used to identify diseases or health conditions.

Examples include:

• Blood glucose monitoring systems
• Rapid diagnostic test kits
• Diagnostic reagents
• Pathology and laboratory testing devices

These devices must meet strict quality and safety standards because they directly affect diagnosis.

2. Medical Equipment Used in Hospitals

Many machines used in hospitals and clinics fall under MD-42.

Examples:

• Infusion pumps
• Nebulizers
• Patient monitors
• Oxygen concentrators

Since these devices are used on patients, proper licensing is mandatory.

3. Surgical and Invasive Devices

Devices that enter the human body during treatment need strong regulatory control.

Examples:

• Surgical instruments
• Catheters
• Stents
• Needles and syringes

These products are sensitive and require approval before manufacturing.

4. Implantable Medical Devices

Implants stay inside the body for a long time, so they are closely regulated.

Examples:

• Orthopedic implants
• Dental implants
• Cardiac implants

Manufacturers must follow detailed safety and testing rules for these devices.

5. Medical Consumables

Disposable medical products are also covered under MD-42 if notified.

Examples:

• Examination gloves
• Face masks used in medical settings
• IV sets
• Surgical dressings

Even though these are single-use items, quality control is very important.

Who Needs an MD-42 License in Bihar?

You need an MD-42 license if:

➜ You are manufacturing medical devices in Bihar

➜ Your device is listed under regulated medical devices

➜ You plan to sell or distribute the device in India

Each manufacturing unit must apply separately, even if the same company has multiple factories.

Basic Requirements for MD-42 License

To apply for an MD-42 license, manufacturers must ensure:

➤ Proper manufacturing facility

➤ Qualified technical staff

➤ Quality management system in place

➤ Required documents and device details

➤ Inspection readiness

Approval is given only after authorities are satisfied with compliance.

Why MD-42 License Is Important

An MD-42 license is not just a legal requirement—it also builds trust.

Benefits include:

→ Legal approval to manufacture medical devices

→ Better credibility with hospitals and distributors

→ Improved product safety and quality

→ Reduced risk of penalties or shutdowns

Final Note

Medical device rules in India are becoming stricter to protect patient safety. If your product is covered under regulated devices, applying for an MD-42 license in Bihar is essential.

Understanding whether your device needs licensing is the first step. Proper compliance helps your business grow smoothly and legally.

Need help with MD-42 licensing in Bihar?
PSR Compliance guides you through CDSCO requirements, documentation, and approvals.
📞 Call +91-7065883416 to get clear, practical support for your medical device registration.

MD-42 License FAQs for Medical Device Sellers in Bihar

1. Is an MD-42 license mandatory for all medical device sellers?
Yes. Since October 1, 2022, anyone involved in selling, stocking, or distributing notified medical devices (Class A, B, C, and D) — including retailers, wholesalers, and distributors — must have an MD-42 registration.

2. What is the validity of the MD-42 license, and does it need renewal?
The MD-42 license is valid for a lifetime. However, you must pay a retention fee of ₹3,000 every five years to keep it active.

3. What is the difference between Form MD-41 and MD-42?

MD-41: The application form submitted to the State Licensing Authority (Bihar).

MD-42: The final Registration Certificate or license issued by the authority after approval.

4. What are the required documents for the MD-42 license in Bihar?
To apply, you need:

• Completed Form MD-41
• Premises ownership or rent agreement
• PAN and Aadhaar of the applicant
• Site plan or layout of the premises
• Self-certification of compliance with Good Distribution Practices (GDP)
• Technical staff qualifications (Pharmacy/Science graduate or 1+ year of relevant experience)

5. Do I need separate MD-42 licenses for multiple branches?
Yes. The MD-42 license is premise-specific, so each retail outlet or warehouse requires a separate license.

6. What is the fee for the MD-42 license?
The government application fee is ₹3,000.

7. Can I sell medical devices online with this license?
Yes. An MD-42 license is required to sell medical devices on e-commerce platforms such as Amazon, Flipkart, or PharmEasy.

8. What happens if I operate without an MD-42 license?
Operating without a valid license can result in:

• Seizure of stock
• Fines ranging from ₹5–10 lakhs
• Possible imprisonment

9. How do I apply for an MD-42 license?
Applications are submitted online through the CDSCO SUGAM portal.

10. What are the storage requirements for medical devices?
License holders must maintain proper storage conditions, including temperature control, as per the manufacturer’s guidelines, and comply with Good Distribution Practices (GDP).