CDSCO has Classified Medical Devices Pertaining to Obstetrical and Gynecological
The list of devices classified into risk category A, B & C is enlisted in the notice and their intended use is provided.
CDSCO has Classified Medical Devices Pertaining to Dental
The list of devices classified into risk category A and B is enlisted in the notice and their intended use is provided.
CDSCO extends due date for submission of details of pre-1988 permitted fixed dose combinations
The Due date for submission of such information previously requested by CDSCO is extended from 25.08.2021 to 25.10.2021.
Ministry of Chemicals and Fertilizers issues operational Guidelines for the Production Linked Incentive scheme for Pharmaceuticals.
Through these revised guidelines the time period allowed for filing the application shall be from 2nd June 2021 to 31st August 2021.
The Drugs (Prices Control) Third Amendment Order, 2021.
he revision of ceiling prices on the basis of moving annual turnover value shall be carried out every five years from the date of fixing the ceiling price under this Order for formulations as specified under the SCHEDULE – I.”
NPPA caps trade margin of 42 anti-cancer medicines.
The National Pharmaceuticals Pricing Policy (NPPP), 2012 prescribes the guidelines for regulation of prices of drugs and the key principles of price regulation are (i) essentiality of drugs (ii) control of prices of formulations and (iii) Market Based Pricing.
CDSCO classifies medical devices pertaining to ENT.
The Drug Controller General has classified 67 medical devices related to ENT including Audiometer testing system, Behind-the-ear airconduction hearing aid, Electroglottograph, Endaural curette, ENT surgical microscope, Flexible fibreoptic nasopharyngo laryngoscope, Nasal septum straightening forceps etc.
CDSCO classifies medical devices pertaining to ophthalmology under the provisions of Medical Devices Rules, 2017.
Any person who intends to apply for grant of licence in respect of medical devices for import/manufacture for sale or for distribution/ sale, stock, exhibit or offer for sale, may group all or any medical device in accordance with the guidelines to be issued from time to time by the Ministry of Health and Family Welfare in the Central Government, by taking into consideration the technological changes or development in the field of medical devices and in vitro diagnostic medical devices.
CDSCO classifies medical devices pertaining to Radiotherapy under the provisions of Medical Devices Rules, 2017.
Based on the classification, class wise list of medical devices shall be published on the website of the Central Drugs Standard Control Organisation: Provided that the Central Licencing Authority may, from time to time, make additions or deletions in such list of medical devices or modify the class of any medical device.
NPPA directs orthopedic knee implant companies to furnish price data by 12th August for price monitoring.
The requisite data on Orthopaedic Knee Implants for Orthopaedic Knee Replacement System in the prescribed format shall be emailed to medicaldevices-nppa@gov.in within 12th August 2021.
