• 2020-05-05 05:53:22

8 medical devices have been newly notified as “drugs” by government of India. These devices will henceforth be closely regulated and monitored for safety and performance.

• 2020-02-12 15:09:17

Nearly eight months after the implementation of the Medical Device Rules 2017, the Indian Pharmacopoeia Commission (IPC) has brought out the first reference document for medical devices manufactured and sold in the country.

• 2020-02-13 06:24:58

According to rule 19 of the Medical Device Rules 2017, the central government may establish “Central Medical Devices Testing Laboratories” for the purpose of

• 2020-02-14 07:32:02

The new medical device rule “MDR 2017, India” has come into effect from January 2018. In line with that, the CDSCO (Central Drug Standard Control Organization) has recently been releasing guidance documents,

• 2020-02-14 07:40:37

In light of the new Medical Device Rules 2017, CDSCO/CLA/SLA shall have updated information of laboratories involved in testing of medical device & in vitro diagnostics with respect to their laboratory reports and decision on performance evaluation of products made by stakeholder/regulator.

• 2020-02-14 07:39:04

The Government of India, Ministry of Health and Family Welfare has released guidelines with respect to Grouping of Medical Devices for applicants who intend to apply for a license to import or manufacture medical devices for sale and distribution in India.

• 2020-02-14 15:20:15

India's central medical device regulator, the Central Drugs Standards Control Organization (CDSCO) published, on November 1, 2017, a revised risk classification of medical devices and IVDs on the basis of their intended use. This is an extremely important development for the medical device and IVD industry because from January 1, 2018 onwards,

• 2020-02-15 06:32:51

The Government of India notified in February 2017 the new Medical Device Rules 2017, which will come into force starting January 1, 2018. The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices.