MoHFW issues Medical Devices (Amendment) Rules, 2020 effective 1st April, 2020; registration of medical devices to be voluntary till 1.10.2021, post which mandatory registration will be required
The Ministry of Health and Family Welfare (“Ministry”) has, in a Notification dated 11th February, 2020, issued the Medical Devices (Amendment) Rules, 2020 (“Amendment Rules”), to...
Continue ReadingTelangana Drugs Control Administration Department introduces online process for filling Applications regarding Medical Devices, IVDs of Risk Class A and B through the CDSCO portal
The Telangana Drugs Control Administration Department (“Department”) has by two Notifications on their website informed that: Applications regarding Medical Devices, IVDs of Risk Class A and...
Continue ReadingIRDAI issues Guidelines on Migration and Portability under the IRDAI (Health Insurance) Regulations 2016
In a Notification dated 1st January, 2020 the Insurance Regulatory and Development Authority of India (“IRDAI”) has issued the Guidelines on Migration and Portability (“Guidelines”)...
Continue ReadingIRDAI issues Guidelines on Standard Individual Health Insurance Product to ensure a common policy unit across entire industry
On 1st January, 2020 the Insurance Regulatory and Development Authority of India (“IRDAI”) has issued the Guidelines on Standard Individual Health Insurance Product (“Guidelines”) under the...
Continue ReadingMOHFW extends timeline within which all implantable medical devices / CT scan / MRI equipment’s / X-ray machines / Dialysis machines, etc. will be considered as ‘Drugs’ till 01.04.2021
The Ministry of Health and Family Welfare (“Ministry”) has extended the timeline within which the list of devices will be considered to be ‘drugs’ as...
Continue ReadingDepartment of Health Services, Madhya Pradesh issues Madhya Pradesh Clinical Establishments (Registration & Regulation) Bill, 2019, proposes to repeal the Act of 1973
The Department of Health services, Government of Madhya Pradesh has issued the Madhya Pradesh Clinical Establishments (Registration & Regulation) Bill, 2019 (“Bill”). The Bill seeks...
Continue ReadingNow, non-bedded clinical establishments in Haryana too will have to obtain registration under the Haryana Clinical Establishments (R & R) Rules, 2018, effective 10.12.2019
The Health Department, Government of Haryana, issued the Haryana Clinical Establishments (Registration and Regulation) Amendment Rules, 2019 (“Amendment Rules”), which is amending the Haryana Clinical...
Continue ReadingAll healthcare professionals and clinicians must inform Authorities about the Materiovigilance Programme of India to ensure proper monitoring of medical devices; says CDSCO
In a Notification dated 26th November 2019 the Central Drugs Standard Control Organisation (“CDSCO”) has stated that all healthcare professionals and clinicians must inform and duly...
Continue ReadingAERB shuts down the operation of 11 medical diagnostic X-Ray machines in North Eastern States owing to radiation safety non-compliances; issues warning on 99 x-ray machines to meet regulatory and safety requirements
In a recent update dated 11th October, 2019, the Atomic Energy Regulatory Board (“AERB”), has informed about the shut-down of operations of some medical diagnostic X-Ray machines in North...
Continue ReadingDirectorate of Health Services, Delhi issues corrigendum on the classification of laboratories and qualification for signing of laboratory reports in Delhi NCT
Directorate of Health Services, Government of Delhi NCT (Directorate) has issued a corrigendum on the classification of laboratories and qualification for signing of laboratory reports....
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