The MD-5 License is a mandatory certification for the manufacturing of Class A and Class B medical devices in India, regulated under the Medical Devices Rules, 2017 and governed by the Central Drugs Standard Control Organization (CDSCO). It is issued by the State Licensing Authority (SLA) and is essential for ensuring compliance with safety and quality standards. To obtain the MD-5 License, manufacturers must submit an application through the SUGAM portal, along with necessary documents such as ISO 13485 certification, a plant master file, a device master file, and details of key personnel. An inspection is conducted to verify compliance with Good Manufacturing Practices (GMP) before approval. Once granted, this license authorizes the manufacturer to legally produce and market Class A (low-risk) and Class B (low to moderate-risk) medical devices within India.

•Purpose: The MD 5 License is required for companies that wish to manufacture (and in some cases, distribute) medical devices classified as Class A or Class B in India. These classes cover low-risk (Class A) and low-to-moderate-risk (Class B) devices. For example, Class A devices include items such as surgical gloves and thermometers, while Class B devices might include hypodermic needles or infusion sets.

•Regulatory Authority: This license is issued by the State Licensing Authority under the oversight of the Central Drugs Standard Control Organization (CDSCO).

1. Initial Application (Form MD 3):

Manufacturers begin by submitting an application on Form MD 3 via the appropriate online portal (often through the SUGAM portal). This form collects detailed information about the manufacturing premises, company constitution, and the range of devices to be produced.

2. Documentation Requirements:

Along with Form MD 3, applicants need to submit several supporting documents, such as:

• Site Master File: Details of the manufacturing facility.
• Device Master File: Technical and quality-related documentation for each device.
• Quality Management System (QMS) Compliance: Certification like ISO 13485 is generally required, as it ensures that the manufacturing processes meet international quality standards.

• Additional documents may include a test license (if applicable), fee receipt, and an undertaking stating that the facility complies with the regulatory requirements.

3. Inspection and Audit:

The State Licensing Authority or an approved Notified Body (especially for Class B devices) inspects the facility to confirm that it meets the required quality and safety standards.

4. Issuance of MD 5 License:

Once the application, documentation, and facility inspection meet all regulatory criteria, the authority issues the manufacturing license on Form MD 5.

5. Timeline and Fees:

After the evaluation, the TEC either approves the proposal or makes recommendations for modifications, improvements, or additional work. They may also set conditions for approval.
• Timeline: The entire process typically takes around 4 to 6 months.
• Fess: For example, fees might be around ₹5,000 per manufacturing site inspection and an additional ₹500 for each distinct medical device registered.

6. License Validity and Renewal:

The MD 5 License remains valid indefinitely provided that the manufacturer pays the license retention fee every five years.

• Regulatory Compliance: It ensures that the manufacturing processes are safe, effective, and in compliance with the Indian Medical Device Rules.
• Market Access: Only manufacturers holding this license are legally allowed to produce and distribute Class A and Class B medical devices in India.
• Quality Assurance: By enforcing standards such as ISO 13485 within the QMS, the MD 5 process helps maintain high levels of product quality and patient safety.

• Classifications: Medical devices in India are classified based on risk:

• Class A: Low-risk devices.
• Class B: Low-to-moderate-risk devices
• Higher-risk devices (Classes C and D) follow a different licensing process

• Notified Body Audit: For Class B devices, an on-site audit by a registered Notified Body is a critical part of the process to verify that the facility meets all quality and safety standards.

• Ongoing Compliance: After obtaining the license, manufacturers must continually adhere to the regulatory requirements, including periodic audits and timely renewal of their license every five years.

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