To manufacture an In Vitro Diagnostic Device, the intended manufacturer needs to get a Manufacturing License for IVD from SLA (State Licensing Authority) and CDSCO(Central Rugs Standard Control Organization).  Classification of whether SLA or CDSCO gets the license is done depends on risk parameters. Medical device Rules regulate the Procedure to obtain a Manufacturing License for IVD. To obtain the manufacturing license for IVD, we need to follow the procedure given below:-

Step 1: Apply to obtain a Manufacturing License for IVD

The applicant should submit an application with the CDSCO in the requisite form, with essential fees and a specified challan.

Step 2: Scrutiny of Application

If any shortcomings or discrepancies are noted, the department raises the question and informs the applicant about them. After scrutiny, if the application is the actual order, the notified body prepares it for an audit according to the medical device rule.

Step 3: Audit of applicant premises by a notified body

If any Non-Compliance is there, the applicant is required to improve it. Then, the notified body shares the audit and NC closure reports with the applicant.

Step 4: Inspection Of Audit Report

After the examination, if the audit report is adequate, it is forwarded to the next step.

Step 5: Product Scrutiny

The next step is scrutinizing the products’ details; if the products comply with all regulations and norms, the application is considered for getting a license.

Step 6: Grant Of License

All required conditions and norms are fulfilled, and the In Vitro Diagnostic Device Manufacturing License is issued to the applicant company.

Overview to obtain Manufacturing License for IVD

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

In vitro diagnostic devices are kits, reagents, instruments, and systems used to diagnose a disease or other health conditions, including identifying the state of health to treat, cure, or prevent disease or its sequelae. These products are intended for collecting, preparing, and examining samples taken from the human body.

Classification of IVD

According to the Medical Device Rules of 2017, In-Vitro Diagnostic Devices are classified  as follows –

Classification based on Risk

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

• Low Risk-Class A,
• Low moderate-risk-Class B,
• Moderate high Risk-Class C.

Classification based on Indented use of IVD

Based on the Parameter Notified in Part II of the First Schedule of Medical Device Rule 2017 and under Chapter II, Rule 4, Sub Rule (2) of Medical Device Rules 2017, the IVD are categorized 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 Procedure to obtain a Manufacturing License for IVD?

SLA (State Licensing Authority)

For Manufacturing Class A and Class B, IVD, SLA is empowered to grant a license in all states and UT of India. The manufacturing company should submit its application to the State Drugs Control Authority, which has 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)

The CDSCO, under the Directorate General of Health Services, Ministry of Health and Family

Welfare, Government of India, is the National Licensing authority or central authority for India’s Class C & D OF IVD devices/kits.

Documents Required to Obtain Manufacturing License for IVD

1. Covering Letter

2. Application Form.

3. Receipt of fees challan

4. Documents of the Constitution of the firm, including the following

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

5. Documents of  Rent agreement or Site Ownership

6. For the master file, additional Documents to be submitted that include the following

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

7. Performance Evaluation Report (if applicable)

8. Copy of Test License (if applicable).

9. Undertaking that the company’s manufacturing site complies with the provisions of the Fifth Schedule. To apply for a loan license on Form MD-4, the following additional Documents are required:

10. In case of loan license consent letter from the principal manufacturing unit.

11. Wholesale licenses of applicant loan licensee.

12. Valid manufacturing licenses and copies of product permission of the product in query of the principal manufacturer.

Forms for application to obtain Manufacturing License for IVD

Form MD 3: It is an Application for grant of license to manufacture for sale and distribution of Class A and Class B medical devices

Form MD 5: It is a License to manufacture devices for sale and distribution of Class A and Class B devices

Form MD 4: It is an Application for a grant of loan License to manufacture devices for the sale and distribution of Class A and Class B medical devices

Form MD 6: It is a Loan License to manufacture devices for sale and distribution of Class A and Class B medical devices

Form MD 7: It is an Application for grant of license to manufacture for sale and distribution of Class C and Class D medical devices

Form MD 9: It is a License to manufacture devices for sale and distribution of Class C and Class D medical devices

Form MD 8: It is an Application for the grant of a loan License to manufacture devices  for the sale and distribution of Class C and Class D medical devices

Form MD 9: It is a Loan License to manufacture devices for sale and distribution of Class C and Class D medical devices