Regulatory Approvals And Pathway For The Manufacture Of Ventilators Amid COVID-19
India is presently grappling with an acute shortage of ventilators in its fight against coronavirus. Ventilators do not fall under any regulated medical device category at present in India. Ventilators may also be coming under the regulated category soon. Once this happens the present regulatory pathways followed for ventilators will change and manufacturers or importers need to apply for manufacturing license or import license.
Read MoreRegulations for Hand sanitizers and home drug deliveries by CDSCO in India
Regulations regarding hand sanitisers and home deliveries of the drugs, along with the list of approved formulations for hand sanitisers
Read MoreNew Notification on Regulating All Devices – Deciphering the Key Concepts
The Medical Devices Rules (MDR), 2017 came into effect from 1st January, 2018. On February 11, 2020, two major notifications related to the Medical Devices Rules, 2017 were published by the Government of India. The notifications included: A new definition of medical devices. The Medical Devices (Amendment) Rules, 2020 As […]
Read MoreDeciphering The Medical Devices Amendment Rules 2020
Infograph of the timelines for obtaining the registration for medical devices and IVD in India. The registration shall be on voluntary basis for a period of eighteen months (1st April 2020 to 30 Sep 2021), from the commencement of this rule, after which (from 01 October 2021), it shall be […]
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The Indian Ministry of Consumer Affairs Relaxes Import Norms of Infrared Thermometers
With the spurt in demand for infrared thermometers in India due to Coronavirus pandemic, the Government of India has eased down procedures at the custom level for easier import of the non-contact infrared thermometers by issuing no-objection certificate (NOC) for release of these medical devices.
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CDSCO prioritizes Regulatory Approval of In-vitro Diagnostic Kit for COVID-19
World Health Organization (WHO) has declared Corona virus Disease (COVID -19) as a global pandemic. A recent coronavirus outbreak is a public health emergency of international concern due to its rapid transmission and spread. So far, till March 1, 2020 there have been 191,127 confirmed cases, and among them, 7807 […]
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Usage of Personal Protective Equipment Rationally During COVID-19 Pandemic
The frontline healthcare workers are facing a shortage of Personal Protective Equipment (PPE), viz. face masks and shields, gloves and gowns. The Ministry of Health and Family Welfare (MOHFW) released guidelines on the rational use of PPEs for health care professionals to be followed all over the country. This is applicable for points of entries (POEs), quarantine centres, healthcare facilities like hospitals, laboratories, and primary health care / community settings.
Regulation/Guidelines
Release of Consignments of Vaccines and In-vitro Diagnostics in COVID-19 Pandemic
CDSCO released the notification for release of vaccines, IVDs and blood products (sampled 100% testing) from the ports after reviewing the documents, protocol, and certificate of release batch by the manufacturer and past satisfactory history of the product.
Regulation/Guidelines
CDSCO Announced Clinical Trials Conduct Rules During COVID-19 Outbreak
This guidance document covers the actions that sponsors of ongoing clinical trials affected by the present pandemic should take to ensure the integrity of the research studies and interpretation of study results while safeguarding the safety of clinical trial participants as a priority