India has been rapidly racing towards becoming one of the biggest hubs for pharmaceutical supplies and other medical facilities. As the scope of the sector is widening, the government keeps it at the top of their priority list to maintain a robust regulatory mechanism to track each step from production to trade. The manufacturing, import, …
How to Register and Get CDSCO Licensing During the Pandemic?Read More »
The manufacturinggeriatric of medical devices in India depends on various factors such as, increase in the population, scientific advancements, the support of government for programs of healthcare, increase in life expectancy. In addition, the rise in technology, including internet speed, artificial intelligence, and machine learning, enables development in medical device manufacturing in India. However, due to …
India: The Fastest Emerging Destination For Medical Device ManufacturingRead More »
美国食品和药物管理局(FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) have jointly identified 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). These guiding principles will help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine …
Good Machine Learning Practice for Medical Device DevelopmentRead More »
Introduction MDCG has combined the Q&A on addressing the most pertinent questions relating to custom-made devices falling under Regulation (EU MDR). Specifically, the MDR regulatory status of adaptable medical devices and patient-matched medical devices is clarified in this Q&A. We have provided below some questions and answers from the same document. You can find …
Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices …
Clarity on Classification of Neurological Medical DevicesRead More »
Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices …
Clarity on Classification of Radiotherapy Medical DevicesRead More »
Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices …
Clarity on Classification of Cardiovascular Medical DevicesRead More »
Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices …
Clarity on Classification of Physical Support Medical DevicesRead More »
Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices …
Clarity on Classification of Radiology Medical DevicesRead More »
Safety, quality and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and rules made thereunder. For the regulation of medical devices with respect to the import, manufacture, clinical investigation, sale and distribution, the Central Government, after consultation with the Drugs Technical Advisory Board, has notified Medical Devices …