The purpose of this service is to obtain license to manufacture Class A and B IVD's in India. The State Licensing Authority is the regulatory body associated with this service. It grants the license to manufacture IVDs for sale or distribution in FORM MD-5 as per Medical Device Rules, 2017.
Any person or manufacturing company wanting to manufacture a Class A or Class B IVDs must follow a certain procedure. The applicant must submit an application to the SLA through the Ministry of Health and Family Welfare's online portal in FORM MD-3.
A manufacturer can apply for permission to manufacture Class A & B IVD's in FORM MD-3 to obtain a Grant of License in FORM MD-5.
The Applicant must follow the following process:
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Step 1: Collect a list of essential documents like cover letter, location ownership/ agreement/ tenancy, etc. |
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Step 2: Apply and submit through Form MD-3 to the SLA for manufacturing, sales, or distribution of Medical Devices. |
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Step 3: Wait for the review process of the submitted documents and Forms. |
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Step 4: Allow an inspection of the manufacturing site conducted for Class B Medical Devices. |
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Step 5: After the review, the SLA will grant the manufacturer permission and the manufacturing license in Form MD-5. |
The license validity lasts forever, subject to the completion of payment before five years from the date of its issue unless it is suspended by SLA.
The major documents involved are:
MD-5from Central Drugs Standard Control Organisation
4 to 5
MONTHSThe Quality Control Data must be generated based on the valid Test License during the application submission process.
No. The manufacturer does not have an option to choose the Notified Body. The Notified Body is appointed under sub-rule (1) of Rule 13 of Medical Device Rules, 2017. This body is competent in auditing the manufacturing sites of Class A and Class B Medical Devices. It verifies their compliance with the Quality Management System and other applicable standards as stated under MDR 2017concerning medical devices (IVDs) as and when the SLA advises.
Yes. The manufacturer must sign an undertaking stating that the manufacturing site complies with the provisions of the Fifth Schedule of Medical Device Rules, 2017. It must be submitted in case of manufacturing Class B, C and D Medical Devices.
Yes. Business continuity will be considered once devices are classified under notified categories. The manufacturer should adhere with the Medical Device Rules, 2017 for the business continuum.
No, the local clinical investigation/evaluation requirement for already marketed and notified medical devices cannot be waived off. These marketed devices will be evaluated based on their intended use to confirm their safety and effectiveness. In case the matter may be placed before the SEC.