Introduction of Medical Devices

The production of medical devices necessitates strict adherence to regulations specified by the Central Drug Standard Control Organisation (CDSCO). Furthermore, individuals looking to produce Class A or Class B medical devices must complete a process by requesting a permit to market or distribute medical devices. The CDSCO guarantees the quality and safety of medical devices being sold in the market in this way.

Applicants must seek approval from the Ministry of Health and Family Welfare through the State Licensing Authority's online portal, based on their location. To obtain a license as FORM MD-5, a completed application in FORM MD-3 and the required documents must be submitted.

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Role of CDSCO in Medical Devices

The CDSCO is the licensing authority in India responsible for standard control. Summarizing the licensing process: Complete the thorough Form MD-3 application and submit it on the SUGAM portal. State licensing authorities approve to produce of Class A and B devices on Form MD-5 following a rigorous assessment.

In India, the regulation of all medical devices and in-vitro diagnostic devices falls under the Medical Device Rule, 2017. Medical devices and in-vitro diagnostic devices are categorized into four groups known as A, B, C, and D, based on the degree of risk linked to the devices. Companies wishing to produce medical devices in India are required to possess a medical device license issued by the appropriate licensing authority.

The regulatory body in charge of issuing manufacturing licenses for Class A and B devices is the State Licensing Authority. CDSCO is the authority in charge of granting manufacturing licenses for Class C & D. To manufacture Class A and Class B devices, you need to obtain the Medical Device Manufacturing License on Form MD 5 from the State Licensing Authority.

The MD 5 License for manufacturing Class A or B Medical Devices and IVDs must be applied for using Form MD 3 and will be issued on MD 5. Before seeking an MD 5 License, the applicant must meet the Medical Device Rule, 2017's criteria.

What is Form MD-3 and Form MD-5?

The MD-3 form is a necessary document in India according to the Medical Devices Rules, 2017, overseen by the CDSCO. This form is designed specifically for bringing in medical devices categorized as Class C and Class D, including high-risk devices. The MD-3 form plays a crucial role in the regulations for importing high-risk medical devices into India. By making sure that these devices adhere to strict safety and quality requirements, the form safeguards public health and upholds the integrity of the medical device market in the nation.

MD-5 form is the official license granted for production. After carefully examining FORM MD-3, CDSCO issues a license for producing, selling, or distributing Class A or Class B medical devices.

The necessary document to acquire permission for producing Class A & B Medical Devices includes the following forms: 

• MD 3 Form:- The manufacturer must submit this application for a license grant to sell and distribute Class A & B medical devices.
• MD 5 Form:- It is the ultimate license granted by CDSCO for the distribution or sale of Class A and Class B medical devices after thorough document review and approval.

Applications for Manufacturing of Medical devices License In India

Companies producing Class A or Class B medical devices must follow a process of applying for a license to market or distribute their products. The manufacturers need to request approval from the Ministry of Health and Family Welfare through the online portal of the State Licensing Authority, based on where the applicant is located. In India, permission to manufacture Class A-B medical devices requires the completion of Form MD-3 and Form MD-5. Aside from these forms vary depending on the intended application purpose. Form MD-26 is the registration document for new or innovative medical devices being licensed for the first time in India. CDSCO, the regulatory body of India, is responsible for approving the production/import of new medical devices within the country.

Read Our Blog: Application Procedure for Class A and B Medical Devices

How to Apply for MD-3 and MD-5 License?

The State Licensing Authority must be contacted via FORM MD-3 for approval to manufacture, and sell. Or distribute medical devices. A set of papers must be provided with FORM MD-3 such as: 

• Step 1: involves registering as a user on CDSCO’s SUGAM Portal. Register your organization on the portal
• Step 2: Complete the Application Form MD-3 by filling in the form and then submit it via CDSCO's online SUGAM portal
• Step 3: Involves uploading the needed documents, such as the site master file and device master file, and making the necessary payment
• Step 4: Involve the State Licensing Authority in Scrutinizing your application. If the requirements are satisfied, a compliance audit for the quality management system will be conducted.
• Step 5: Involves an audit of your facilities by a notified body that has been authorized by the CDSCO. In case a Non-Conformance (NC) is found, you must provide a report for closing the NC
• Step 6: Involves the approval of the MD-5 license, which will be granted by the state licensing authority once all requirements have been fulfilled

Validity for Form MD-5

A license that has been approved as FORM MD-5 shall be valid for five years from the date on which it is issued by the State Licensing Authority by the 2nd Schedule, subject to payment of the license renewal fee promptly. However, a License can be suspended or canceled by the State Licensing Authority based on competent reasons at any point in time.

Timeline for Form MD-3

The process of applying for the Grant of License to manufacture, sell, or distribute Class A and Class B medical devices requires a long list of procedures, paperwork, and forms. Initially, the SLA carefully reviews the application (Form MD-3). Next, a Notified Body is designated to perform an inspection of the production facility. The Manufacturing license is only issued by the SLA after a successful audit. So, it typically takes around 4-5 months to obtain the manufacturing license.

Conclusion

Forms MD-3 and MD-5 are required to acquire a manufacturing license for the planned In-Vitro product. The authorization to manufacture may be applied for by any authorized manufacturer of medical devices with a valid wholesale production licence Class A.