facebook tracking

Endorsement of Predicate In Vitro Diagnostics in Manufacturing License in India - MD 7 & MD 9


ENQUIRE NOW


    CliniExpert-usp test license

    CliniExperts is a company that provides the Medical Device manufacturers with 360-degree regulatory solutions. Backed by over a decade’s experience in the field of Medical Device compliances, manufacturing licenses and regulatory approvals, our team is fully prepared to obtain licenses and approvals for producing your Medical Devices.

    Endorsement of Predicate In Vitro Diagnostics in Manufacturing License – Overview

    The (CDSCO) has notified all medical device manufacturers according to the Medical Device Rules, 2017. It states that the manufacturers must get form MD-9 (endorsement manufacturing license). It is necessary Before producing any new products besides those that have already received approval. To get a license in Form MD-9, the manufacturer must apply in Form MD-7. It can be applied to the Central Licensing Authority via a designated online portal of the Central Government. This is done to get a license to manufacture and distribute Class C and Class D-notified Medical Devices. Usually, it takes 4-6 months for the license to be issued after the application is submitted.
    form md 7 md 9

    Who Can Apply?

    The application is open to any manufacturer of Medical Devices in India.

    Endorsement of License for Predicate In Vitro Diagnostics Manufacturing License in India - MD 7 & MD 9

    How To Apply?

    The Applicant must follow the following process:

    To obtain an endorsement license to manufacture for sale and distribution of a Class A or Class B medical device, the manufacturer must submit Form MD-3 along with the required documents to the State Licensing Authority. The application must include the following documents:
    • icon

      Prepare Application Form: Begin by filling out Form MD-7, which is required to apply for a Grant of License to Manufacture for Sale and Distribution of Class C or Class D medical devices.
    • icon

      Assemble Required Documents: Cover Letter, Include Constitution details of the firm ,provide proof of Establishment/Site ownership or a Tenancy Agreement, attach a notarized copy of the Quality Certificate concerning the manufacturing site, Plant Master File, Device Master File etc.
    • icon

      Include Additional Documentation: Prepare and attach the Plant Master File. Include the Device Master File detailing the medical device specifics. Attach documentation of the Quality Management System as specified in the Fifth Schedule of the Medical Device Rules.
    • icon

      Special Documentation for IVDs: If applicable (for In Vitro Diagnostic devices only), include a Performance Evaluation Report.
    • icon

      Compliance Undertaking: Include an Undertaking signed by an authorized representative, stating that the manufacturing site complies with the provisions of the Fifth Schedule.
    • icon

      Submission of Application: Submit the completed Form MD-7 along with all the attachments to the Central Licensing Authority.
    • icon

      Inspection and Review: Following your submission, the Central Licensing Authority will conduct a review of the application. This includes an inspection of the manufacturing site for Class C and D medical devices, which may be carried out by Medical Device Officers, with or without an expert or a Notified Body.
    • icon

      Receipt of License: Upon successful review and inspection, an Endorsement Manufacturing License in Form MD-9 will be issued by the Central Licensing Authority.
    icon

    Validity

    A Form MD-9 license stays valid forever if the retention fee is paid every five years. This rule applies unless the license is suspended or canceled by the Central Licensing Authority.
    icon

    Fee Involved

    There is a government fee of Rs. 1000 for the loan license application process for each distinct medical device of class C or class D.

    Important Documents

    Important Documents
    During the documentation process, the following documents should be present:
    • QMS documents
    • Device Master File

    Timeline to get MD 9from Central Drugs Standard Control Organisation

    4-6

    Months

    Essential Tips

    The primary considerations that need to be made while preparing and submitting this license application are:
    • The applicant's manufacturing facility must comply with the Fifth Schedule's Quality Management System (QMS) criteria.
    • Device master files and site master files must be ready in accordance with MDR 2017 format.
    The obstacle or issue that is most likely to arise when filling out or applying for the manufacturing license is that the product's technical documentation does not comply with MDR 2017.
    Expert Advise

    According to the experts, the manufacturers should produce the quality control data using a valid test license at the time of application submission.

    Related Services

    navigate

    Test license to import In Vitro Diagnostics (Form MD 16, 17)

    Importers | Regulatory Body: CDSCO

    Do you need permission to import in-vitro diagnostic kits to India to demonstrate its performance? CliniExperts’ professionals have the expertise and assist you in securing in-vitro diagnostic kits test license for importer.

    Permission to conduct Clinical Performance Evaluation (Form MD 24, 25)

    Manufacturer / Importer | Regulatory Body: CDSCO

    CliniExperts is backed by a well-informed and experienced team who guides through all the documentation and paperwork required for the regulatory processes.

    Permission to Manufacture Class C & D In- Vitro Diagnostics (Form MD 7, 9)

    Manufacturer | Regulatory Body: CDSCO

    At CliniExperts, our team of experts is thoroughly updated with the latest requirements of the various authorities, enabling complete and meticulous documentation, timely application and quick approvals/licenses.

    Permission to Manufacture Class A & B In Vitro Diagnostics (Form MD 3, 5)

    Manufacturer | Regulatory Body: CDSCO

    The application for manufacturing, sale or distribution of any medical device includes a tedious list of processes and forms CliniExperts team consists of experts working in the same domain with practical experience and knowledge of the governing rules.

    navigate

    Frequently Asked Questions

    When can one expect an inspection by CDSCO for the manufacturing site of class C and D Medical Devices?

    The applicants can expect the inspection by CDSCO within sixty days from the date of submission of the application.

    How many members of the audit team are prescribed in MDR 2017?

    A minimum of two Medical Device officers, which may also include an officer senior to the Medical Device officer, with or without an expert or a notified body, make up the inspection team.

    What is the timeline for inspecting classes C and D and granting of license?

    Class C and D licenses will be inspected by the Central Licensing Authority within 60 days of the application date. If the Central Licensing Authority is satisfied that the requirements of these rules have been met, it may grant a license 45 days after receiving the inspection report.

    Does an application for a license to manufacture have to include the requirement in the fourth schedule, which states that producers have to give a promise that they would abide by the terms of the fifth schedule?

    If Class B, C, and D Medical Devices are to be manufactured, a signed undertaking attesting to the production site's compliance with the fifth schedule of Medical Device rules, 2017 must be presented.

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

    1. The medical equipment must meet the criteria set forth by the Bureau of Indian Criteria, which was founded under section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985), or as may regularly be notified by the Central Government's Ministry of Health and Family Welfare.
    2. If sub-rule (1) does not specify a relevant standard for any Medical Device, the device shall comply with the standard established by the International Electro-Technical Commission (IEC), the International Organization for Standardization (ISO), or any other pharmacopoeia standard.
    3. If sub-rule (1) and sub-rule (2) do not specify a standard, the device shall comply with the validated manufacturer's standard.