Ministry of Consumer Affairs issues Direction for implementation of exemptions under the Legal Metrology (Packaged Commodities) Rules, 2011 on Medical Device
The Ministry of Consumer Affairs (“Ministry”) has issued an order reiterating the following provisions of the Legal Metrology (Packaged Commodities) Rules, 2011 […]
Medical Devices Rules amended to provide for setting up of State Medical Devices Testing Laboratories
The Department of Health and Family Welfare, vide the Medical Devices (Amendment) Rules, 2023, has introduced the provision for State Medical Devices […]
Andhra Pradesh Health Department advises manufacturers, dealers, wholesalers etc. against sale of Ultrasound Machines without ensuring valid registration certificate and NOC under PC & PNDT Act
The Office of the Commissioner of Health and Family Welfare in Andhra Pradesh has advised manufacturers, dealers, wholesalers, retailers and persons dealing […]
Health Ministry proposes to simplify registration procedure for Class A (Non-Sterile and/or non-measuring) Medical Devices under Medical Device Rules, 2017; invites comments / suggestions by 27th September, 2022
The Ministry of Health and Family Welfare (“Ministry”) has published draft amendments to propose further changes to the Medical Device Rules, 2017 […]
CDSCO rolls out updated list of medical devices pertaining to rehabilitation under the Medical Devices Rules, 2017
In continuation to what we reported earlier (please refer to the e-mails in trail), Central Drugs Standard Control Organization (“CDSCO”) has updated […]
Manufacturers of medical devices directed to apply for manufacturing license for devices through online portal ; Quality certificates from other entities not replacement for license : CDSCO
The Central Drugs Standard Control Organization (“CDSCO”) has notified that quality certificates issued to the manufacturers under the Medical Devices Rules, 2017 […]
Ministry of Health publishes the draft of New Drugs, Medical Devices and Cosmetics Bill 2022; invites suggestions / comments / objections till 22.08.2022
With a view to keep pace with changing needs, times, and technology, the Ministry of Health and Family Welfare (“Ministry”) has proposed […]
Ministry of Health amends the Medical Devices Rules, 2017; prescribes suspension and cancellation of licence for manufacturer or licensee for failure to comply with conditions of an import license; effective immediately
Ministry of Health and Family Welfare has notified the Medical Devices (Third Amendment) Rules, 2022 in order to amend the Medical Devices […]
Public comments invited on draft amendments to Medical Device Rules, 2017; proposes requirement of registration to sell/ distribute, stock, exhibit medical devices; last date for submission of comments: 26th March, 2022
The Ministry of Health and Family Welfare (“Ministry”) has proposed the draft Medical Devices (Amendment) Rules, 2022 (“Draft Amendment”) to introduce further […]