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CDSCO Import License for Medical Devices In India

Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.

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CDSCO Import License for Medical Devices In India

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  1. CDSCO Import License for Medical Devices In India CDSCO Import License in India | Operon Strategist

  2. How Operon Strategist Will Help You in CDSCO Import License? Operon strategist is the leading medical device regulatory consulting company. We help our guests in making specialized dossier for the licensing process, we also solve the queries raised by the regulators, and we're delivering turnkey services, system implementation, training, licensing, regulatory approvals and certificates. CDSCO issues Medical devices importing license under the Directorate General of Health Services in the Ministry of Health & Family Welfare. Speed up your import licensing process with us; Operon Strategist will assist you at every step of medical device importing license.

  3. GUIDELINES FOR IMPORT AND MANUFACTURE OF MEDICAL DEVICES The Ministry of Health andF.W. under Gazette notificationS.O. 1468( E) dated6/10/2005 declared the following sterile devices to be considered as drugs under Section 3( b)( iv) of the Act. • Cardiac Stents. • Drug Eluting Stents. • Catheters. • Intra Ocular Lenses. • Cannulae. • Bone Cements. • Heart Valves. • Scalp Vein Set. • Orthopedic Implants. • Internal Prosthetic replacements. It was also notified vide GSR 627( E) dated7/10/2005 that control over manufacture of these devices would be exercised by CLAA i.e. DCG( I) under the said Rules.

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