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
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.
- (CDSCO) Central Drugs Standard Control Organization.
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
Documents Needed to Complete the License Application.
- A letter of cover.
- Application Form.
- Necessary documents for the firm's constitution, such as
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.
- 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.
How to get a license to manufacture in vitro diagnostic devices.
- Application for IVD Manufacturing License Grant.
The applicant must submit an application in the required form, together with the required fees and the designated challan, to the CDSCO.
- Application scrutiny
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.
- Notified body audits the applicant's premises
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.
- Reviewing the audit report
After the examination, if the audit report is deemed satisfactory, it moves on to the next phase.
- Scrutiny of Product
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.
- License Grant
The application company receives the In Vitro Diagnostic Device Manufacturing License if all the regulations and requirements are met.
Why go with Ornate?
One of the most reliable platforms in India for a variety of services, such as government registration and licensing services, is Ornate.Despite the drawn-out compliance process, our team of knowledgeable and experienced professionals makes sure that our clients receive top-notch services. We supply official licenses and registrations on schedule. Provide thorough assistance during the Registration procedure to facilitate the acquisition of an In Vitro Diagnostic Device Manufacturing License in India with ease.
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