News
SEC Committee: Pioneering Medical Approvals
New important article released by Central Drugs Standard Control Organization (CDSCO) titled “SEC – Special Expert Committee, Medical Devices”. Key highlights include the streamlined processes for CDSCO application evaluations, preparation and significance of briefing materials, and structured procedures to enhance the efficiency of SEC meetings. Click here to know more.
TUV SUD Inspects IVD Medical Devices’ Cyber Security
The growing digital connectivity of medical infrastructure is resulting in complicated systems with a plethora of diverse interfaces that are potentially vulnerable to assault. The IVD requires producers to provide proof of cyber security before releasing their products to the public. Transitional periods for currently certified IVD medical devices will
Regulation of all Licensed Class A and B Medical Devices by October 2022
This article released on 30th September 2022 talks about the importation of Class A and B Medical Devices according to a notification issued by the Ministry of Health & Family Welfare (MoHFW) on February 11, 2020. It has been released that if an existing importer or manufacturer who is already
Medical Device Makers are Told to get license by Oct 1, 2022 for Hassle Free Import
This article deals with the new rules of the Tamil Nadu Government that Medical Device Makers should get the import license on or before October 1 or else action will be taken. The Tamilnadu State Drug Control Director, Vijayalakshmi said that they have created awareness among the small and medium
India – one of the top markets for GE Healthcare Intercontinental
The CEO of GE Healthcare has recently released a statement wherein he says that “India is among the top four out of the 60 countries and when it comes to technology, India is number one. GE recently launched a manufacturing site in India which is the base for healthcare in
Increasing Importation of Medical Devices affecting SME’s
This news article deals with the increasing demand for Imported Medical Devices and Products into India. In India, the Medical Device Industry Importation has surged by 41% this year leading to the shut down of several local indian companies. The local manufacturers cannot compete with the rate of imported products
New Draft Regulations for IVD’s in India
This news article deals with the updates in the IVD regulations in India. They have come up with three drafts as follows – Draft Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD) – The CDSCO has issued an article on PMS (Post Market Surveillance) of IVDs in India.
CDSCO (G.S.R 877(E) – Drugs & Cosmetics Act (Amendment) Rules, 2021
This news deals with the latest Amendment which has been published by the CDSCO. The CDSCO has released a new Amendment in the Drugs and Cosmetics Act, 1945 with Notification number S.O.877(E) published on 23rd December,2021.The Draft rules for amendment are as follows – Note: The Medical Devices Rules, 2017
Covishield Booster Dose
The CDSCO and The Subject Expert committee has informed that COVID -19 booster dose cannot be recommended or used without clinical trials. The Serum Institute had given an application for Booster Dose of Covid-19 on December 9th, 2021 to the SII Committee. The SEC Committee has reviewed the application from
Extension in Shelf Life for Import of Medical Devices, India
The CDSCO has published a special condition under which the permission for Import of drugs with residual shelf life less than 60% is extended until next year. Due to the COVID-19 situation, the effective date of the circular dated on 17th April 2020, 10th July 2020 and 13th April 2021