Permission to Manufacture Class A & B In Vitro Diagnostics in India – MD-3 & MD-5


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    The seasoned and updated professionals at CliniExperts will assist you in every step of the application process in filing the FORM MD-3 and obtaining the Grant of License to manufacture Class A & B IVDs in FORM MD-5.

    Permission to Manufacture Class A & B In Vitro Diagnostics– Overview


    The purpose of this service is to obtain license to manufacture Class A and B IVD's in India. The State Licensing Authorit 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 Rule 2017.

    Any person or manufacturing company wanting to manufacture a Class A or Class B IVDs must follow a certain procedure. The applicant must make an application to the State Licensing Authority (SLA) through the identified online portal of the Ministry of Health and Family Welfare in the Central Government in FORM MD-3.

    What is MD-3 and MD-5

    Form Names

    MD-3

    FORM MD 3- is the application form required to be submitted by the manufacturer for the Grant of License for sale or distribution for Class A or Class B Medical Devices (IVD's).

    MD-5

    FORM MD5- is the Grant of License issued by the CDSCO to manufacturers for the sale or distribution of Class A or Class B Medical Devices (IVD's).

    Who Can Apply?


    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.


    How To Apply?

    The manufacturer must apply for the Grant of License to manufacture for sale and distribution of Class A or Class B Medical Devices in FORM MD-3 to the SLA. The following documents need to be submitted along with the application:
    Step 1: A cover letter
    Step 2: Constitution detail of the firm, the Establishment/Site ownership/Tenancy Agreement
    Step 3: A copy of duly notarised valid copies of the Quality Certificate concerning the manufacturing site,
    Step 4: Plant Master file, Device Master file, Performance Evaluation Report (IVDs only)
    Step 5: Test License obtained for testing and generation of quality control data
    Step 6: Undertaking signed mentioning the manufacturing site complies with the provision of the Fifth schedule. The State Licensing Authority reviews the application and appoints a Notified body to conduct an audit of the manufacturing site for Class B Medical Devices. Upon successful audit, the SLA issues the manufacturing license in FORM MD-5.

    Fee Involved

    The Government charges specific fees for the manufacturing Grant of License-

    • For the one site manufacturing Class A or Class B Medical Devices, the charges include 5000 INR.
    • For each distinct medical device of Class A or Class B, the charges are 500 INR.

    Validity

    The license validity lasts forever, subject to the completion of payment before five years from the date of its issue unless it is suspended or cancelled by SLA.

    Important Documents

    The major documents involved are: Device Master File Site Master File QMS Documents

    Timeline to get Form MD-5 from Central Drugs Standard Control Organisation

    The timeline to receive the manufacturing license is 4-5 months

    Essential Tips

    The following tips will be beneficial during the application process:

    1. The manufacturing site of the applicant Class A and B Medical Device should comply with the requirements of the Quality Management System as specified under the Fifth Schedule of MDR 2017


    2. The Device Master files and Site Master files need to be prepared per the format of Medical Device Rules, 2017.


    Problems might be faced by manufacturers if the technical documents of the products are not in line with Medical Device Rules, 2017. So, placing all documents as per the MDR 2017 checklist is necessary.

    Expert Advise

    CliniExperts provides the following advice to their clients-

    The Quality Control Data must be generated based on the valid Test License during the application submission process.

    Related Services

    Frequently Asked Questions

    Will the manufacturer have an option to choose Notified body?

    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 MDR2017concerning medical devices (IVDs) as and when the SLA advises.

    If a manufacturing firm is complying with ISO/IEC standards, would it still need to follow BIS standards?

    • Yes. The manufacturing firm needs to follow BIS standards. The medical device manufacturing firm should adhere to the standards put forth by the BIS established under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.
    • Where no relevant standard of any medical device has been laid down under sub-rule (1), such device should comply with the standard made by the International Organization for Standardization (ISO) or the International Electro-Technical Commission (IEC) or by any other pharmacopoeia standards.
    • In case the standards are not specified under sub-rule (1) and sub-rule (2), the device should follow the validated manufacturer’s standard.

    Does the fourth schedule's requirement imply that manufacturers shall submit an undertaking to follow the provisions of the fifth schedule while applying for a license to manufacture?

    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.

    If devices that are currently on the market but haven't been notified are added to the list of notified devices, would business continuity be considered?

    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.

    For devices already in the market and notified later, would the local clinical investigation/evaluation requirement be waived off?

    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.

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