Medical Device Manufacturing Loan License for Class A B, Form MD 4, MD 6

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What is FORM MD-4 and FORM MD-6?

CDSCO

FORM MD-4 and FORM MD-6

As per the Medical Devices Rules of 2017, any enterprise seeking a loan license to manufacture Class A or Class B medical devices must submit an application. In vitro diagnostic devices may also fall under the categories of Class A or Class B medical devices due to their low or low-to-moderate risk nature. The manufacturer is required to submit an online application through the Ministry of Health and Family Welfare's online portal via the State Licensing Authority, utilizing Form MD-4 and Form MD-6, to obtain a Loan License for the continued sale and distribution of Class A and Class B medical devices. Form MD-4 can be utilized to apply for a Loan License for Manufacturing for Sale or Distribution of a Class A or Class B medical device. This discussion will focus on Form MD-4 and Form MD-6.

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Regulatory Bodies

Regulatory responsibilities for medical devices are divided between the State and Central Governments, depending on the device category. The State Licensing Authority (SLA) is responsible for supervising the production of Class A and B medical devices using FORM MD-4 and FORM MD-6. Under its supervision, all four classes of devices will be sold and distributed.

Classification of Medical Devices in India

The Central Drugs Standard Control Organization (CDSCO) in India categorizes medical devices into four groups, depending on the degree of risk they present to patients and users. This classification system is determined by the device's intended use and the potential harm it may cause in case of malfunction. For further clarity on the classification of medical devices, please refer to the provided document titled "Clarity on Medical Device Classification."

Below are the four classifications of medical devices according to CDSCO:

Class A: Low-risk medical devices, like stethoscopes, bandages, and other essential medical instruments, pose minimal to no risk of harm to patients or users.
Class B: The licensee must allow the Medical Device Officer to access the premises, whether with prior notice or not, to verify that only authorized activities, such as clinical investigations, tests, evaluations, examinations, demonstrations, or training, are being carried out.
Class C: Medical devices categorized as moderate-to-high risk include artificial heart valves, orthopedic implants, and catheters, which have the potential to cause significant harm or injury to patients if they malfunction.
Class D: High-risk medical devices, such as pacemakers, heart-lung machines, and ventilators, are crucial for the health and survival of patients. If these devices malfunction, they could result in severe harm or even death.

Form MD-4 and Form MD-6: Meaning

Applications and permits for the sale and distribution of medical devices are submitted using FORM MD-4 and FORM MD-6, respectively. Form MD-6 issues a Loan License for manufacturing for the sale or distribution of Class A or Class B Medical Devices, while Form MD-4 serves as an application for the grant of a Loan License for manufacturing for the sale or distribution of Class A/Class B Medical Devices.

What is a Medical Device Manufacturing License?

The application process involves requesting a grant, loan, or license for the sale or distribution of products. As per the Medical Devices Rules, 2016, applications and licenses can be submitted online via Forms MD-4 and MD-6 at the Ministry of Health and Family Welfare. This category encompasses Class A and Class B medical devices.

Prerequisites for Issuing a Manufacturing or Loan License via Forms MD-4 and MD-6

Upon receiving a license or loan license through Forms MD-4 and MD-6, the licensee must comply with the following conditions:

When requested by the Medical Device Officer or any other senior official from the Central Licensing Authority or State Licensing Authority, the license must be presented.
The license holder is required to inform the State Licensing Authority or the Central Licensing Authority about any suspected unexpected serious adverse event and provide details of the actions taken within a period of 15 days.
Prior to implementing any substantial changes, the license holder must obtain permission. The Sixth Schedule outlines the process for making such requests. Subsequent to obtaining approval, the license holder is obligated to furnish the details to the State Licensing Authority or Central Licensing Authority within 45 days
As per Rule 83 and Sub-rule (3), the licensee is required to conduct laboratory tests before releasing the products. The Central Licensing Authority or the State Licensing Authority must receive all documentation related to these tests.
In compliance with Rule 83 and its Sub-rule (3), the licensee must conduct laboratory tests before product release. All test documentation should be provided to either the Central Licensing Authority or the State Licensing Authority.
Form MD-11 must contain documentation for every audit.
Following expiration, all test samples must be stored for 180 days.
The licence holder must keep track of sales and manufacturing, and must appear when the medical officer requests it.
Notification to the Central Licensing Authority or the State Licensing Authority is required if the medical device manufacturer ceases production of the devices for a period exceeding 30 days.

Procedure for Application of License Grants for Class A and Class B - Forms MD-4 and MD-6

The applicant is required to undergo registration with the Ministry of Health and Family Welfare.
To initiate a license application, the applicant must upload Form MD-3 with all necessary details.
For the submission of a loan license application, the applicant is required to upload Form MD-4 containing all requisite information. As delineated in the Second Schedule of Part II, the form must be uploaded concurrently with the fee.
As per the relevant sub-rule, all pertinent details must be uploaded accordingly.
Before submitting the undertaking as specified by the Quality Management System, the applicant must upload the required documentation.
The State Licensing Authority is responsible for conducting an investigation into the submitted application.
After conducting an investigation, the State Licensing Authority must issue the manufacturing license in Form MD-5.
The State Licensing Authority must provide the loan licence in the form MD-6.
The State Licensing Authority is required to issue a written notice to the applicant within 45 days in case of license rejection.

Validity of a License

If the license issued in Form MD-4 and Form MD-6 is not revoked or suspended by the State Licensing Authority, its validity will remain indefinite, provided that the license maintenance fee is paid as per the Second Schedule before the end of the five-year period starting from the date of issuance.

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