The Indian government’s intention for many years to oversee registration of medical devices in India with a developed regulatory structure which is still not materialized but there were a number of steps taken to move the medical device registration to a substantial one. To look after the growing medical device market and its regulations, the government of India has proposed for the National Medical Devices Authority (NMDA). READ ALSO: Important Licenses and Forms to Keep in Mind: CDSCO
The responsibility of the NMDA would be to ensure safety and effectiveness of the medical devices in the country. It would also look after the selling price levels of medical devices and manufacturing domestically in India. READ ALSO: Documents Required for Manufacturing License in India. Only 22 notified medical devices are currently regulated with the requirement of regulatory approval one of the GHTF countries (United States, Canada, Europe, Japan, or Australia) under the Ministry of Health and Family Welfare and the Central Drugs Standard Control Organization (CDSCO). This measure to a stringent regulatory system would increase the transparency and also the manufacturers interest to enter Indian market.
Other News
India Medical Device Pricing Strategy: Ensuring Growth & Affordability
India’s National Pharmaceutical Pricing Authority (NPPA) is developing a specialized India medical device pricing strategy for medical devices, transitioning away from the conventional drug-centric framework. This innovative strategy will incorporate international pricing tactics tailored to […]
Read MoreImports of High-Value Medical Equipment
High-Value Medical Equipment The Central Drugs Standard Control Organization (CDSCO) and the Central Board of Indirect Taxes & Customs have released a new circular, “F.No.401/40/2021-Cus.III,” detailing updated policies on the import of used high-end medical […]
Read MoreSEC 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, […]
Read More
ErlySign Oral Cancer Detection Technology Gets CDSCO Nod
ErlySign, a Nagpur-based biotech startup, has received approval from the Central Drugs Standard Control Organization (CDSCO) to conduct large-scale clinical trials for its novel oral cancer detection technology. The approval for ErlySign follows a rigorous […]
Read MoreAdditional Steps Announced by FDA to Modernize Clinical Trials
The U.S. Food and Drug Administration has made draft guidance available with updated recommendations for good clinical practices (GCPs), which are intended to modernize the clinical trial design and conduct while maintaining data integrity and […]
Read MoreAccreditation and Registration Numbers for Foreign Manufacturers Publication by PMDA
This article deals In accordance with the Pharmaceuticals and Medical Devices Act (PMD Act) of Japan, foreign businesses that wish to produce pharmaceuticals, quackery products, active pharmaceutical ingredients (APIs), or medical devices abroad and import […]
Read MoreBSI New Certification to Mitigate Antimicrobial Resistance Risk in Antibiotic Manufacturing
BSI, the business improvement and standards company, has developed a new certification to mitigate the risk of antimicrobial resistance (AMR) in antibiotic manufacturing. The certification, called the Minimized Risk of Antimicrobial Resistance (AMR) certification, will […]
Read 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 […]
Read More
