World Trade Organization (WTO) have been notified by Ministry of Food and Drug Safety (MFDS) that it intends to change the cosmetic regulation for imports. One of the changes would be conditions of use of sterilising preservative ingredients in cosmetics. READ ALSO: Regulatory Process of South East Asian markets, Indian Registration Process.

The other changes that regulatory consultants have to observe are, wet tissue added under the scope of the cosmetics, Fluorescence brightening agent and xylene are to be added in the negative list. The notice were issued in March. READ ALSO:  More about Ministry of Food and Drug Safety (MFDS).

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  • CDSCO medical device license retention

CDSCO Issues Guidelines on Medical Device License Retention

New Delhi, May 15, 2024 — The Central Drugs Standard Control Organization (CDSCO) has released a circular (F. No. MED-15/35/2024-eOffice) on the retention of medical device licenses and certificates under the Medical Devices Rules, 2017. […]

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  • Medical Devices

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 […]

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Imports 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 […]

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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, […]

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  • ErlySign's Oral Cancer Detection

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 […]

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Additional 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 […]

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Accreditation 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 […]

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BSI 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 […]

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