Manufacturing Licenses for Class A &; B Medical Devices (Forms MD-3, MD-5)

MD-5 refers to the Manufacturing License granted by the State Licensing Authority (SLA) under the CDSCO (Central Drugs Standard Control Organisation) to manufacturers for producing and selling Class A or Class B medical devices (including In Vitro Diagnostic Devices – IVDs) within India.

Who Needs MD -5

Companies established in India who intend to manufacture and sell Class A or Class B medical devices require this license. Here’s a breakdown of the device classifications:

·         Class A Devices: These are considered low-risk medical devices, such as:

o   Bandages

o   Tongue depressors

o   Surgical drapes

·         Class B Devices: These are categorized as low-to-moderate risk devices, including:

o   Stethoscopes

o   Syringes

o   Surgical instruments

Benefits of Obtaining MD-5:

• Market Access: It allows you to participate in the growing Indian medical device market.
• Legal Authorization: MD-5 grants legal permission to manufacture and sell Class A or Class B medical devices in India.
• Credibility: Having a CDSCO-approved manufacturing license enhances your company’s reputation in the Indian market.

Process to Obtain MD-5 License:

The process for acquiring an MD-5 Manufacturing License involves following stages:

1. Application:

·         The manufacturer submits an online application on the CDSCO portal using Form MD-3. This form captures details about:

§  The company

§  Manufacturing facility

§  Proposed medical devices (Class A or Class B)

§  Responsible personnel within the company

2. Documentation:

·         Along with Form MD-3, the manufacturer needs to submit various documents proving compliance with the Medical Device Rules, 2017. These may include:

§  Company registration documents

§  Manufacturing facility layout plans

§  Quality Management System (QMS) documentation (demonstrating adherence to ISO 13485 is highly recommended)

§  Technical specifications and design dossiers for the medical devices

§  Labelling information

3. Inspection:

·         The CDSCO may conduct an inspection of the manufacturing facility to verify compliance with the regulations.

4. Approval:

·         Upon successful review of the application, documentation, and potential inspection, the SLA grants the manufacturer a license to manufacture and sell Class A or Class B medical devices. This license is issued in the form of MD-5.

5. Validity:

·         The MD-5 Manufacturing License is generally considered valid permanently. However, the manufacturer needs to pay a license retention fee periodically (every five years) to maintain its validity.

The Role of MDR Consultants:

§  Expertise in CDSCO Regulations: MDR consultants possess in-depth knowledge of the Medical Device Rules, 2017, and can guide you through the entire licensing process.

§  Documentation Preparation: They can assist you in preparing the necessary documentation according to CDSCO requirements, saving you time and effort.

§  Communication with Authorities: MDR consultants can effectively communicate with the CDSCO and State Licensing Authority on your behalf, addressing any queries or concerns they may have.

§  Risk Management and Quality Management Systems: They can help you develop and implement robust Risk Management and Quality Management Systems (QMS) that comply with regulatory standards.

Obtaining an MD-5 license can be a complex process with intricate regulations. MDR (Medical Device Regulation) consultants can play a vital role in ensuring a smooth and successful application process. Here’s how they can help:

§  Increased Success Rate: By leveraging their expertise, you can significantly increase your chances of obtaining the MD-5 license efficiently.