Overview of InVitro Diagnostic Device Manufacturing License

The Drug and Cosmetic Act 1940 & Rules of 1945 regulate the manufacturing provision of In-vitro diagnostic devices/kits/reagents (IVD). Earlier, there were no provisions for the registration of IVD in India. However, in the year 2017 Government of India published an official notification for the registration of medical devices and IVD. There are, in total, 462 Products classified as medical devices and 250 products as IVD under the New Rules of the Government of India.

In vitro diagnostic devices are those kits, reagents, instruments, and systems intended to diagnose a disease or other health conditions, including determining the state of health to cure, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body.

Classification of IVD

Medical Device Rules of 2017 classify In-Vitro Diagnostic Devices as follows - 

Classification based on Risk

In vitro diagnostic medical devices are classified based on risk parameters as specified in Part II of the First Schedule as under:

• Low Risk – Class A;
• Low moderate-risk- Class B;
• Moderate high Risk- Class C;
• High Risk- Class D

Classification based on Indented use of Respective IVD

Under chapter II, Rule 4, Sub Rule (2) of medical device Rules 2017 and based on Parameter Notified in Part II of the First Schedule of Medical Device Rule 2017, the IVD are classified as under

• In-Vitro Device for HIV
• In-Vitro Device for HBV
• In- Vitro Device for HCV
• In-Vitro blood grouping sera

Who regulates the Licensing Procedure for Manufacturing of IVD?

SLA (State Licensing Authority)

SLA is empowered to grant a license for Manufacturing of Class A and Class B IVD in all states and UT of India. The manufacturing company must submit their application to the State Drugs Control Authority having the jurisdiction over the manufacturing premises. The applicant must submit all relevant technical and administrative documents to the State Licensing Authority requesting licenses to manufacture IVDs.

CDSCO (Central Drugs Standard Control Organization)

CDSCO, under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, is the central authority or National Licensing authority for Class C & D OF IVD devices/kits in India.

Overview of Forms for application 

Documents Required for Filing Application for Licensing

1. Covering Letter
2. Application Form.
3. Receipt of fees challan
4. Documents of Constitution of the firm including

• Partnership deed in case of partnership firm
• Memorandum & Articles of Association for company registered under the Companies Act, 2013
• Declaration of total number of Proprietor/ Partners/ Director(s)/ Managing Director
• Documents of age and postal/residential address of all partners and directors

5. Documents of Site ownership or Rent agreement
6. Additional documents to be submitted for the master file

• Declaration of Manufacturing Chemist.
• Declaration of Analytical Chemist.
• Documents of educational qualification, experience and approval certificates of proposed Manufacturing Chemist & Analytical Chemist; Appointment Letters; Id proof.
• Registration from District Industries Centre.
• Consent to establish & consent to operate from Rajasthan State Pollution Control Board.

7. Performance Evaluation Report (if applicable)
8. Copy of Test License (if applicable).
9. Undertaking that the manufacturing site complies with the provisions of the Fifth Schedule. Following additional documents are required if applied for a loan license on Form MD-4:
10. Consent letter from principal manufacturing unit in case of loan license.
11. Wholesale licenses of the applicant loan licensee.
12. Valid manufacturing licenses and copies of product permission of the product in question of the principal manufacturer.

Steps for obtaining In Vitro Diagnostic Device Manufacturing License

STEP 1 Application for grant of IVD Manufacturing License

The applicant must file an application with the CDSCO in the requisite form, along with necessary fees and challan specified.

Step 2 Scrutiny of application

If any shortcomings/discrepancies are noted, the Authority raises the query and informs the applicant regarding the same. After scrutiny, if the application is in proper order, it is processed for audit by the notified body as per the Medical Device Rule.

Step 3 Audit of applicant premises by notified body

If there is any Non-Compliance, the applicant must rectify it. The notified body then shares the audit report and the NC closure report with the applicant.

Step 4 Examination of Audit report

If the Audit report is found to be satisfactory after the examination, it is forwarded to the next step.

Step 5 Products Scrutiny.

The next step is scrutiny of details of products applied; if the products comply with all norms and regulations, the application is considered for grant of License.

Step 6 Grant of License

 If all the required norms and conditions are fulfilled, the In Vitro Diagnostic Device Manufacturing License is granted to the applicant company.

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