Mon Dec 11 2017 ,13:28:16
Medical Device

About Us

A medical device is any instrument, apparatus, appliance, software, material, or other article-whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application-intended by the manufacturer.Medical devices vary according to their intended use and indications. Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as computers which assist in the conduct of medical testing, implants, and prostheses. The design of medical devices constitutes a major segment of the field of mechanical engineering.

List of medical devices and in vitro diagnostic medical devices placed at Annexure-I IS subjected to the followings:

  • General intended use given against each of the devices is for guidance to the applicants intends to furnish application of import or manufacture of medical devices under the provisions of Medical Devices Rules, 2017. However, a device may have specific intended use as specified by its manufacturer.
  • The component and accessories to a medical device or companion in vitro diagnostic medical devices has been classified separately.
  • It is also recognised that some of the medical devices or in vitro diagnostic medical devices may have dual use and they may be classified accordingly.
  • This list is dynamic and is subject to revision from time to time under the provisions of the Medical Devices Rules, 2017.

Features

pill Consumer Forms For Medical Devices pill Click here to Apply/Check status of the Applications

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Contact Us

Phone

91-11-23216367(CDSCO)/ 23236975

Fax

91-11-23236973

Address

Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health and Family Welfare,Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002