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Guidance Document - CDSCO

Guidance Document ON COMMON SUBMISSION FORMAT FOR MANUFACTURING OF NOTIFIED medical devices UNDER CLAA SCHEME Page | 1 Guidance Document ( medical devices division ) Title : Guidance Document on application for grant of Licence in Form-28 for manufacture of medical devices in India under CLAA Scheme Doc No : CDSCO /MD/GD/CLAA/01/00 Date : Effective Date : 01st January 2013 central DRUGS STANDARD CONTROL ORGANIZATION DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH & FAMILY WELFARE GOVT. OF INDIA Guidance Document ON COMMON SUBMISSION FORMAT FOR MANUFACTURING OF NOTIFIED medical devices UNDER CLAA SCHEME Page | 2 Table of Contents Content Page No.

(Medical Devices Division) Title : Guidance document on ... Date : 31.10.2012 Effective Date: 01st January 2013 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH & FAMILY WELFARE ... In India import, manufacture, sale and distribution of Medical devices is regulated under Drugs and …

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Transcription of Guidance Document - CDSCO

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STEPS TO BE FOLLOWED BY THE MANUFACTURERS/ …

www.cdsco.gov.in

Guidance Document for Manufacturers / Importers for voluntary/ mandatory registration of Medical Devices Documents required for Registration of medical devices by the Manufactures: - 1. Name & address of the company or firm or any other entity manufacturing the medical device along with name and address of

  Guidance, Manufacturers, For manufacturers

Central Drugs Standard Control Organization

www.cdsco.gov.in

registration of the manufacturing premises) and Schedule D(II) (for registration of the drugs): - Applicant shall make a payment of 1500 USD (or its equivalent to Indian Currency), as registration fee for the Manufacturing premises. - Applicant shall make an payment of 1000 USD (or its equivalent to

  Registration

THE DRUGS AND COSMETICS ACT, 1940 - CDSCO

www.cdsco.gov.in

The Act has been applied to all the partially excluded areas in the State of Orissa, see Orissa Government Notification No. 3358-LSG., dated the 25th August, 1941. 2. Ins. by Act 21 of 1962, s. 2 (w.e.f. 27-7-1964). 3. Subs. by the A.O. 1950, for certain words. 4. The words ―except the State of Jammu and Kashmir‖ omitted by Act 19 of 1972 ...

  Drug, Cosmetic, Orissa, 0914, The drugs and cosmetics act

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