If you manufacture medical devices in India, you must obtain a manufacturing license from the regulatory authority of India. Manufacturing license for medical devices of class A and B is issued under Form MD-5 as per Medical Device Rules, 2017. This license is issued by the Central Drug Standard Control Organization (CDSCO) after inspecting the manufacturing premise, ensuring the manufacturing site follows regulatory compliance as per regulatory standards. A manufacturing license grant under Form MD 5 is filled under Form MD 3 application to grant a legal permit for manufacturing class A or B medical devices. We have prepared a detailed process for obtaining MD 5 license for manufacturing license for Class A and B medical devices in India.

Overview Of MD 3 and MD 5 License For Medical Device In India?

Form MD 3 – Form MD-3 is an application form filled and submitted by the manufacturer or business owner to obtain a manufacturing license from the State Licensing Authority for the manufacturing of class A and B medical devices in India. MD-3 is the important step in ensuring that the manufacturing process adheres to the regulatory standard as per the Medical Device Rules, 2017.

Form MD 5 – Form MD-5 involves the manufacturing license certificate issued by the State Licensing Authority in India, for manufacturing the medical device of class A and B. After reviewing the complete application Form MD-3 and successful inspection of the manufacturing site, the regulatory authority issues a manufacturing license under MD-5, ensuring manufacturing process compliance meets the quality and safety standards.

About Class A & Class B Medical Devices

Medical Devices in India are classified into four categories from class A to D based on the risk they cause to users as per “Indian Medical Device Rules 2017″:

• Class A Medical Devices: These are Low-risk Medical Devices. They cause very minimum risk to patients and are used for non-invasive and simple processes (e.g., surgical gloves, thermometers, tongue depressors and bandages).
• Class B Medical Devices: These are  Low to Moderate-risk devices and they cause more risk than class A medical devices. they are used for common medical purposes (e.g., hypodermic needles, infusion sets)

Importance of Categorizing Medical Devices On The Risk Level

The various importance of Categorizing Medical Devices based on their Risk Level:

• Ensure patient safety
• Maintain Regulatory Compliance of devices
• Help in focusing on Targeted regulations of high-risk devices class C and D

Regulatory Framework Governing the MD 5 License 

The Medical Devices Rules, 2017, introduced under the Drugs and Cosmetics Act, of 1940, establish a robust regulatory framework for the licensing, registration, and oversight of medical devices in India. These rules align India’s regulations with international standards, ensuring the safety, quality, and effectiveness of medical devices within the healthcare system. Additionally, they define the classification of medical devices based on risk levels, facilitating appropriate regulatory controls.

Role of the Central Drugs Standard Control Organization (CDSCO):

• The Central Drug Standard Control Organisation(CDSCO) is the governing regulatory of India which looks after medical device regulation in India
• It is the Central Licensing Authority (CLA) that grants licenses to Class C and Class D medical devices  which is of high risk and very high risk
• It oversees the import of medical devices to ensure that the product complies with Indian regulations.

Role of State Licensing Authorities (SLAs) 

• SLAs are responsible for regulating Class A and B medical devices
• They issue licenses for the manufacturing and sale of these lower-risk devices and conduct inspections to ensure compliance with regulatory standards.

Significance of Notified Bodies

Notified Bodies are third-party organizations authorized to assess whether medical devices comply with regulatory standards. The various significance of notified bodies are:

• For Class A and B medical devices, Notified Bodies assess the quality management systems, manufacturing processes, and safety documentation to ensure compliance with the Medical Devices Rules, 2017.
• Their involvement reduces the regulatory burden on the CDSCO and SLAs, allowing for a faster approval process while maintaining safety and performance standards.

Who Can Apply For MD 5 License In India? 

Manufacturer, who wants to manufacture and sell the medical devices of class A and B categories can apply for an MD 5 license.

Companies who want to manufacture class A and B medical devices on their manufacturing premise can apply for an MD 5 license.

Why do You Need an MD 5 license For Class A & B Devices? 

To manufacture the medical devices of class A legally and B category or in-vitro diagnostic medical devices in India, the manufacturing license is mandatory to obtain under Form MD-5.

List Of Documents Required For MD 5 License For Manufacturing Of Class A and B Medical Devices

Following are the key documents an applicant must submit to obtain the manufacturing license under MD-5, by the CDSCO, Medical Device Rules, 2017:

• Form MD-3
• Device Master File
• Site Master File
• ISO 13485 Certificate
• Fee Receipt
• Company Details
• Memorandum of Association
• Performance Evaluation Report
• Test License

Prerequisites To Obtain MD 5 License For Manufacturing Of Class A and B Medical Devices

The following are the Pre-requisites an applicant shall meet to obtain an MD 5 license:

1. Quality Management System (QMS) compliance as per ISO 13485:2016.
2. Adequate infrastructure and qualified staff.
3. Necessary documents, including site master file, device master file, and essential safety and performance data.

Procedure For The Grant Of MD 5 License For Manufacturing Of Class A and B Medical Devices

Below are the steps that an applicant shall follow for a seamless grant of a manufacturing license:

• Step 1: Visit the SUGAM portal and register yourself.
• Step 2: Fill out the application form MD-3 and submit it through the SUGAM portal.
• Step 3: Upload and submit the required documents including the site master file, test license, device master file, etc.
• Step 4: Pay the applicable fees.
• Step 5: The application will be reviewed by the State Licensing Authority and if the application is found as per the standard requirement, it will proceed further for quality management system (QMS) compliance.
• Step 6: Inspection by the notified body officer. If the manufacturing premise is found in compliance with the regulatory requirements, the application will proceed further otherwise if non-compliance, then you need to submit a non-compliance closure report to the regulatory authority.
• Step 7: Once all the requirements are found in compliance with the regulatory requirements, the State Licensing Authority will issue the manufacturing license under Form MD-5.

What Are The Required Fees For an MD 5 License? 

Fees for an MD 5 license as per the Second Schedule of Medical Device Rules, 2017, for the manufacturing of class A and B medical devices is ₹ 5000/ per manufacturing site inspection and ₹500/ for each medical device.

What Is The Validity Of MD 5 License? 

The manufacturing license issue under Form MD-5 remains valid for a long time unless the applicant pays the retention fees every five years.

What Is The Timeline For Obtaining MD 5 License? 

It generally takes 4 to 6 months for the grant of a manufacturing license from the State Licensing Authority under Form MD-5.

How We ELT Corporate Can Assist You With MD 5 License? 

We, ELT corporate with deep industry knowledge and expertise can help you in granting of manufacturing license under Form MD-5 for the manufacturing of class A and B medical devices. Let’s collaborate for a smooth and seamless process of obtaining a manufacturing license and to drive your success and meet regulatory compliance. Our offering includes:

• MD-3 Submission
• ISO 13485: QMS Certificate
• Audit Preparation
• CDSCO, SUGAM Portal Queries Response
• GMP Certificate

Frequently Asked Questions (FAQs)