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 India’s unique market demands and […]
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 equipment.The key highlights are that […]
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, and structured procedures to enhance […]
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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 investigation and successful validation of […]
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SEC – Special Expert Committee, Medical Devices
SEC – Special Expert Committee, India Update In the journey of obtaining CDSCO regulatory approval for medical devices in India, comprehending the function of Subject Expert Committees (SECs) is crucial. This article provides an overview of the CDSCO’s comprehensive evaluation […]
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High-Value Medical Equipment: Customs Exemptions
High-Value Medical Equipment: Customs Exemptions In June last year, the Union government issued a notification that allowed the import of refurbished medical devices, excluding critical care equipment, into India. This policy decision authorized the importation of 50 types of high-end […]
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MD-15 Import License, India
MD-15 Import License: In the constantly evolving regulatory landscape of India, obtaining an Import License for medical devices is an important step for manufacturers looking to enter the market. Since the implementation of the Medical Device Rules, 2017, all medical […]
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Cosmetic Import Compliance in India: CDSCO’s New Directive
Cosmetic Import Compliance: Under the 2020 Cosmetics Rules, for importing and selling cosmetics from overseas, an application must be filed via the Central Government’s online portal in Form COS-4, along with an undertaking. Upon satisfaction with the application, the Central […]
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Pricing Framework Reforms: Drugs and Medical Devices, India
Pricing Framework Reforms: Currently, the NPPA follows the regulations which are outlined in the Drugs (Prices Control) Order, 2013 (DPCO-2013) for the prices of medical equipment and medications which are categorized as drugs. In 2012, the National Pharmaceutical Pricing Authority […]
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PSUR India, CDSCO’s Online Submission Requirement
PSUR – Periodic Safety Update Reports The Central Drugs Standard Control Organization (CDSCO) issued a new circular, File No.: PSUR-13011(15)/1/2024-eoffice, on March 9, 2024, which specifies that submissions of PSUR’s (Periodic Safety Update Reports) must now be made through the […]
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