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Import License From CDSCO
(Central drugs Standard Control organization)

The Indian medical device market is thriving and currently has a total worth of about $3 billion (US), with growth anticipated at 12% to 16% over the next five years India is an important destination for foreign medical devices: imported products represent more than 70% of the market. As a huge growth opportunity, regulatory professionals need to closely follow the evolving Indian medical device regulations. Any devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.



In India import, manufacturing, sale and distribution of Medical devices is regulated under Drugs and Cosmetics Act and Rules. At present, following notified Medical Devices are regulated under the said Act. License is valid for a period of three years from the date of its issue

Name of Device
• Disposable Hypodermic Syringes
• Disposable Hypodermic Needles
• Disposable Perfusion Sets
• Cardiac Stents.
• Drug Eluting Stents.
• Catheters.
• Intra Ocular Lenses.
• I.V. Cannulae.
• Bone Cements.
• Heart Valves.
• Scalp Vein Set.
• Orthopedic Implants.
• Internal Prosthetic Replacements.
• In-vitro Diagnostic Devices for HIV, HbsAg and HCV

Registration is not required for import of non-notified medical devices in India. However, the following devices are regulated as “Drugs” under Drugs and Cosmetics Act and Rules, hence registration and import license is required for import in to India.

• Blood Grouping Sera
• Ligatures, Sutures, Staples
• Intra Uterine Devices (Cu-T)
• Condoms
• Tubal Rings
• Surgical Dressing
• Umbilical Tapes
• Blood / Blood Component Bags

This document may also be applicable for submission of application for grant of import license for above products

Requirements for Import Licence of Medical Devices in India

Covering Letter-Purpose should be clearly mentioned with page number and Index.
An Authorization letter in original issued by the Director/Company Secretary/Partner of the Indian Agent firm revealing the name & designation of the person authorized to sign.
Form-8 duly Signed & Stamped by Indian Agent along with name & designation of the Authorized Signatory
Form-9 duly Signed & Stamped by Indian Agent along with name & designation of the Authorized Signatory or duly Notarized, if signed & stamped by the Manufacturer.
TR6 Challan in triplicate.
Notarized & valid copy of Wholesale Licence or Manufacturing Licence of the Indian Agent.
Copy of Registration Certificate
Copy of Import License
A fee of one thousand and five hundred US dollars [or its equivalent in Indian rupees] shall be paid along with the application in Form 40 as registration fee for the manufacturing premises meant for manufacturing of medical device intended for import into and use in India.
A fee of one thousand US dollars [or its equivalent in Indian rupees] shall be paid along with the application in Form 40 for the registration of a single medical device meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional medical device:
Valid Copy of Registration Certificate in form-41
Documents as stated in Registration Certificate issued on condition
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