• 2020-05-06 07:48:03

The Indian Central Drugs Standard Control Organization (CDSCO) has set risk classifications for 12 products scheduled for notification and regulation as medical devices starting April 1, 2020.

• 2020-05-06 02:39:19

Pharmaceutical drugs in India will from now on abide by the newly notified “New Drugs and Clinical Trials Rules, 2019”. These Rules have been issued in hopes that the rules will increase and improve clinical research in India, which hosts only 1.2% of the world’s clinical trials despite having a high burden of disease.

• 2020-05-06 01:48:16

Pharmaceutical drugs in India will now on abide by the newly notified “New Drugs and Clinical Trials Rules, 2019”. These Rules have been issued in hopes that the rules will increase and improve clinical research in India, which hosts only 1.2% of the world’s clinical trials despite having a high burden of disease.

• 2020-05-05 09:53:48

The Indian government has issued draft Quality Control Orders (QCOs) for medical electrical equipment, sphygmomanometers, clinical electrical thermometers, blood glucose monitoring system, gloves and surgical blades, to better ensure their safety and effectiveness.

• 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 04:13:25

The regulatory standards for the approval of IVD devices keep on changing time to time because of the continuous improvements and modifications made related to their better performance level. There was a revision for “glucometer test strips” in 2013 as mentioned in IS/ISO 15197: 2013.

• 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.