InVitro Diagnostic Device manufacturing license
In India, in-vitro diagnostic kits, reagents, and devices are regulated by the Drug and Cosmetic Act 1940 and Rules of 1945. In 2017, the Indian government introduced regulations for their registration.
In vitro diagnostic devices, including kits, reagents, instruments, and systems, diagnose diseases and assess overall health. They aid in disease prevention, treatment, and monitoring by processing and analyzing biological specimens.
Who oversees the Licensing Process for IVT Manufacturing?
- (SLA) State Licensing Authority
- (CDSCO) Central Drugs Standard Control Organization.
- Manufacturing licenses for Class A and Class B in-vitro diagnostic devices (IVDs) in India are issued by State Licensing Authorities. Applicants must submit technical and administrative documents to the State Drugs Control Authority.
- The central authority or national licensing authority for Class C and D OF IVD devices/kits in India is CDSCO, which is a division of the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
Products Covered Under InVitro Diagnostic Device Manufacturing License
Consumer Products
Industrial Products
Specialized Products
Documents Needed to Complete the License Application.
- A letter of cover.
- Application Form.
- Necessary documents for the firm's constitution, such as
- Required Documentation of Site Ownership or Tenancy Agreement.
- More documents that must be supplied for the master file
- The Manufacturing Chemist's Declaration.
- The Analytical Chemist Declaration
- Required Documentation of Experience, Education, and Approval certifications from the proposed analytical and manufacturing chemists; letters of appointment; and evidence of identity.
- Parntership deed in case of Partnership firm.
- Articles of Association and Memorandum for a Company Filed under the Companies Act of 2013.
- Total number of proprietors, partners, directors, and managing directors declared.
- Documents proving the age and mailing/residential address of each director and partner.
How to get a license to manufacture in vitro diagnostic devices.
- Application for IVD Manufacturing License Grant.
- Application scrutiny
- Notified body audits the applicant's premises
- Reviewing the audit report
- Scrutiny of Product
- License Grant
- The applicant must submit an application in the required form, together with the required fees and the designated challan, to the CDSCO.
- The Authority raises the matter and notifies the applicant if any flaws or inconsistencies are found. Following examination, the application is processed for audit by the notified body in accordance with the Medical Device Rule if it is in order.
- If there is any non-compliance, it must be fixed by the applicant. The applicant is subsequently provided with the audit report and the NC closure report by the notified entity.
- After the examination, if the audit report is deemed satisfactory, it moves on to the next phase.
- The products' details are examined in the following phase, and if they meet all standards and laws, the application is taken into consideration for a license.
- The application company receives the In Vitro Diagnostic Device Manufacturing License if all the regulations and requirements are met.
