Know more about CDSCO Import License in India

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.