The registration process in India is about to take a positive change, with the proposal to regulate medical devices and drugs separately. According to AdvaMed, the Indian medical device industry is predicted to be be a US $30 billion in the next 10 years with adequate guidance policy and support. Sanjay Banerji of AdvaMed India said, “The healthcare industry will grow to US $30 billion with proper policies and appropriate regulatory guidance in India. The new draft of the Drugs and Cosmetics Bill, 2015 will provide answers to several challenges the healthcare industry face. Presently, medical devices in India is regulated the same as drugs under the Drugs and Cosmetics Act (Notified Medical Devices in India).”
As one of the Emerging markets, the Indian healthcare industry is likely to grow fast as the statistics show overseas manufacturer interest in the market. Banerji further said: “It may be complicated as they were totally different and should be regulated differently. The new amendment bill will allow classifying medical devices based on risks, separate regulation for medical devices, clinical trials which would make registration of medical devices in India stringent and straight forward (Documents required for Medical Device Registration in India). AdvaMed also recommended reducing the duty for life saving medical devices.
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
