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operon strategist provide consultancy services for CDSCO license Registration

CDSCO (Central Drugs Standard Control Organization) Registration, CDSCO Import License For Medical Device and itu2019s Guidelines.<br><br>Contact details u2013 <br>Phone no - 9325283428<br>Mail - dm@operonstrategist.com<br>Visit us - https://www.operonstrategist.com/turnkey-project-consultants/<br>

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operon strategist provide consultancy services for CDSCO license Registration

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  1. MEDICAL DEVICE MEDICAL DEVICE REGISTRATION IN INDIA REGISTRATION IN INDIA CDSCO CDSCO https://www.operonstrategist.com/cdsco-license-wholesale-registration/

  2. The Medical device industry in India is regulated by the Central Drugs Standard Control Organization (CDSCO) under the regulatory provisions of the Drugs & Cosmetics Act 1940 & Rules 1945. The Central Drugs Standard Control Organization i.e. CDSCO is the national regulatory body for Indian medical devices and pharmaceuticals. It’s a licensing authority. It approves any new chemical entity (drug) which is to be imported to India.

  3. Roles of CDSCO Roles of CDSCO ■ Approval of new drugs and clinical trials. ■ Import CDSCO registration & licensing. ■ Licensing of blood banks, vaccines and some medical devices. ■ Amendment to Drugs & Cosmetics Act and rules. ■ Participation in WHO GMP certification schemes. ■ Grant to test license, personal license, NOC’s for export. ■ Testing of drugs by central labs

  4. •Registration certification for drugs and import license • Form 10 Phase I •Import and registration of medical devices and diagnostics kits. •Services requiring to fill form 41 for the registration Phase II •Application for the import and registration of Cosmetics. •Ethics committee registration. Phase III

  5. Step Wise Medical Step Wise Medical Device Registration Device Registration and CDSCO and CDSCO Guidelines for India Guidelines for India

  6. Step 1: •Check the Product with list of Notified Medical Devices and IVDs Step 2: •firstly appoint an India Authorized Agent to interact with the Central Drugs Standard Control Organization (CDSCO) •Step 3: •India Authorized Agent Power of Attorney to manage your registration in India

  7. Step 4: •Using Form 40 schedules D-1 and D-2 must be included, as well as verification of compliance with US, Canadian, European, Japanese or Australian medical device regulations Step 5: •Require a Form 45 (New Drug License) in support of the Form 40 application.

  8. Step 6: •Obtain Registration Certificate Form 41 from CDSCO Step 7: •Identify your distributor in India (holding forms 20B and 21B).

  9. Step 8: •Apply for Import License using Forms 8 and 9 available from CDSCO. Step 9: Step 9: •Obtain Import License (Form 10) from CDSCO Step10: •You are now authorized to market your device in India.

  10. Thank You. For More Information Contact Us www.operonstrategist.com info@operonstrategist.com +91-9325283428

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