Description of my question: I want to start a business in selling surgical instruments, and laboratory chemical kits from which institution I will get trade licence.
I am ready to become a distributor of surgical instruments, chemical kits, and other medical devices in India.
Answer: Medical devices are classified in 4 category based on risk on human, animal, and environment. This is the guideline given by US food and drug administration to all over the world. Class 1 to class 4. According to the risk factor every country have different rules and regulation to get license for manufacturing, and trading. In our India DGCI and CDSCO mainly work for grant of license.
1. If we talk about class 1 medical devices trading business – license is not required in some states.
2. if we talk about class 2 medical devices – earlier it was not compulsory having license but according to MDR-2017 it is compulsory to have license to sale or stock.
3. Class 3 and class 4 devices sale, stock and exhibition – must have drug license.
Documents required: - 1. Rent agreement /Rent receipt/ electricity bill/proof of ownership of property
2. Proof of constitution of firm 3. Key plan and site plan 4. Address proof of all directors life Adhar card/pan card
5. Board resolution 6. Refrigerator bill and computer bill 7. Storage facility at premises 8. Premises area not less than 10 sq. Metre. 9. Height not less than 2.75 mitre. 10. Appointment letter of pharmacist or competent person. 11. Experience certificate of competent person 12. Educational qualification certificate of competent person. 13. Registration certificate with state pharmacy council of pharmacist 14. 2 passport size photograph of directors/owner/pharmacist/competent person.
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