In Vitro Diagnostic Device Manufacturing License Service In Chennai

The production of in-vitro diagnostic tools, kits, and reagents is governed by the Drug and Cosmetic Act of 1940 and Rules of 1945. (IVD). Before, India lacked any provisions for the registration of IVD. However, in 2017 the Indian government released an official announcement for the registration of IVD and medical devices. Under the New Rules of the Government of India, there are a total of 462 Products classed as medical devices and 250 Products as IVD.

A disease or other health condition can be diagnosed using in vitro diagnostic technologies, which include kits, reagents, tools, and systems. This includes determining one's overall health in order to treat, cure, or prevent disease or its complications. These goods are designed to be used in the collecting, preparation, and analysis of human body specimens.

Classification of IVD

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

Risk-based classification

Medical devices used for in vitro diagnosis are categorised as follows based on risk parameters listed in Part II of the first schedule :

• High Safety Class A
• Class B, low to moderate risk
• Class C: Moderately High Risk
• Risk Class D High

       

Who regulates the Licensing Procedure for Manufacturing of IVD?

SLA (State Licensing Authority)

SLA is authorised to issue a licence for Class A and Class B IVD Manufacturing in all Indian states and the Union Territory. The State Drugs Control Authority with authority over the manufacturing facility must receive the manufacturing company's application. The State Licensing Authority must receive all necessary technical and administrative paperwork from the applicant before issuing any permits to produce IVDs.

CDSCO (Central Drugs Standard Control Organization)

The national licencing authority for Class C & D OF IVD devices/kits in India is CDSCO, which falls under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.

Overview of Forms for application

 

Type of License	Risk /class	Application Form	Approval Form
Manufacturing license	A&B	MD 3 Application for grant of license manufacture for sale and distribution of Class A & B medical devices	MD 5 License to manufacture for sale and distribution of Class A & B medical devices
Loan license	A&B	MD 4 Application for grant of loan License to manufacture for sale and distribution of Class A & B medical devices	MD 6 Loan License to manufacture for sale and distribution of Class A & B medical devices
Manufacturing License	C&D	MD7 Application for grant of license manufacture for sale and distribution of Class C & D medical devices	MD 9 License to manufacture for sale and distribution of Class C & D medical devices
Loan license	C&D	MD8 Application for grant of loan License to manufacture for sale and distribution of Class C & D medical devices	MD 9 Loan License to manufacture for sale and distribution of Class C & D medical devices

 

Documents Required for Filing Application for Licensing

01. Covering Letter

02. Application Form.

03. Fees Challan Receipt

04. Firm's governing documents, including

• In the case of a partnership firm, a partnership deed
• Articles of Association and Memorandum for a Company Registered Under the 2013 Companies Act
• Total number of proprietors, partners, directors, and managing directors declared
• Age and postal/residential address verification forms for all partners and directors

 

05. Documents proving site ownership or a lease

06. Added paperwork should be supplied for the main file

• Chemist's Declaration for Manufacturing.
• Statement from an analytical chemist.
• Documents proving the prospective Manufacturing and Analytical Chemists' educational background, professional experience, and permission; appointment letters; and identification evidence.
• District Industries Center registration.
• The Rajasthan State Pollution Control Board gave its approval for the establishment and operation.

 

07. Report on Performance Evaluation (if applicable)

08. Test License Copies (if applicable).

09. Assuring that the manufacturing location abides by the Fifth Schedule's rules. If a loan licence application is made on Form MD-4, the following additional documents are necessary

10. Letter of consent from the main production unit in the event of a borrowing licence.

11. The application loan licensee's wholesale licences.

12. Copies of the product's product permission from the major manufacturer as well as legitimate manufacturing licences.

Steps for obtaining In Vitro Diagnostic Device Manufacturing License

Step 1 Application for IVD Manufacturing License
A completed application in the required form, along with the prescribed fees and challan, must be sent to the CDSCO by the applicant

Step 2 Scrutiny Of Application
If any errors or discrepancies are discovered, the Authority questions them and informs the applicant. If the application passes inspection and is in order, it is processed for audit by the notified authority in accordance with the Medical Device Rule.

Step 3 Audits of Applicant Premises By Notified Body
Any non-compliance must be fixed by the applicant. The applicant is then given access to the audit report and the NC closure report by the body that was notified.

Step 4 Reviewing the Audit Report
The Audit report is moved on to the following stage if the examination deems it to be satisfactory.

Step 5 Examining the products.
The specifics of the products submitted are examined in the following phase; if the products meet all standards and rules, the application is taken into consideration for the granting of a licence.

Step 6 License Grant
The application company is given an in vitro diagnostic device manufacturing licence if all the requirements and conditions are met

FAQ

 

Where can we find the 2017 medical device regulations?

The CDSCO website has the full text of the 2017 Medical Devise Rules.

Is there a specific rule that applies to in-vitro diagnostic kits in India?

Yes, the Medical Device Rule of 2017 governs all in-vitro kits and reagents in India.

Who assigns IVDs a Class A, B, C, or D classification?

Reference Rule 4 (3) of this regulation states that the Central Licensing Authority must categorise

Who in CDSCO is in charge of inspecting IVD kits and/or reagents?

FDA Bhavan, ITO, Kotla Road, New Delhi -110002: Medical Devices & Diagnostics Division, Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India

An in-vivo diagnosis is what?

It describes the tests, methods, and experiments that scientists do out in or on a complete live organism, such as a human, a lab animal, or a plant.

What exactly is a test licence?

Small Quantities of IVD must be manufactured or imported with a licence for purposes of clinical research or evaluation.