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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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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Uniform Code for Pharmaceuticals Marketing Practices, 2024
On December 12, 2014, the central government released the Uniform Code for Pharmaceuticals Marketing Practices to be voluntarily complied by pharma industries with respect to marketing practices. It was mentioned in the code that if the code is not implemented […]
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Good Manufacturing Practices (GMP) – Pharmaceutical Sector
Good Manufacturing Practices (GMP) in Pharmaceutical Sector: On December 28, 2023, the Ministry of Health and Family Welfare, Government of India, revised the Drugs Rules, 1945, under Gazette Notification Number G.S.R. 922(E), introducing updated Good Manufacturing Practices (GMP) and requirements […]
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India’s Medical Device Grouping Structure
This article gives a brief on India’s Medical Device Grouping Structure – The regulatory landscape for medical device importation and registration in India has undergone significant changes, particularly since an important update in 2020 by the Central Drugs Standard Control […]
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Medical Device Industry in India: Growth Strategies
Introduction on India’s Medical Device Industry: The Ministry Of Chemicals And Fertilizers (Department Of Pharmaceuticals) For The Promotion Of Medical Device Industry Published Its 50th Report in February 2024. This blog covers some of the key highlights from the report […]
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Recall System for Drugs, India Guidelines
This article referring to CDSCO/RRAS Ver.:00 dated 23/11/2012, talks about the essential components of an effective recall system with the procedure to be followed in India and how Morulaa can help manufacturers and importers manage these challenges in case of […]
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