regulation reformsMedical deviceAccording to "Medical Device Rules-2017" (MDR-2017), "Medical Devices (MDs) are the substances which are used for in-vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood, and blood component collection bag ...
Under the Drugs and Cosmetics Act, the regulation of the manufacturing, sale, and distribution of drugs and devices is primarily the concern of state authorities. Central authorities are responsible for approving new drugs, controlling the quality of imported drugs, coordinating the activities of state...
Medical Devices Device Regulations and Medical Device - CCTSI医疗器械,装置的规定,医疗设备cctsi 热度: Medical Device Registration in India印度医疗器械注册 热度: Medical Device Act in Thailand(泰国医疗器械法规) 热度: -1- MEDICALDEVICERULES,2013 ...
increasing India's share in the global medical device industry from $11 billion to $50 billion in the next 10 years. However, there is still a lack of clarity on the Medical Device Reporting (MDR), which is a post-market tool for monitoring device performance. Similarly, it does not add...
The purpose of this review article is to present an overview of the regulatory registration requirement of MD in India according to the new MDR-2017. 展开 关键词: surgical dressings diagnosis national regulatory authority registration requirement regulation reforms Medical device DOI: 10.2174/...
Currently, sixteen medical devices are regulated under MDR, 8 others are regulated as drugs and 13 additional devices are to be included in the MDR over 2021. The slow pace of medical device regulation has been a concern for the industry for some time now. Therefore, while the move to regu...
Recently, the Indian Government has also released notifications significantly increasing the number of medical devices governed by the medical device regulation. Currently, only 16 medical devices are regulated in India, with 13 other medical devices to come under regulation 1. http://www.makeinindia...
The Medical Device Regulation: What Impact Will the New Regulation Have On the Medical Device Industry and How Will Companies Use Standards to Meet the New Requirements. 2021. Reivich K, Gillham JE, Chaplin TM, Seligman ME. From helplessness to optimism: The role of resilience in treating ...
The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI regulation across industries. With its broad territorial scope and applicability, this comprehensive legislation establishes stringent requirements for AI systems. In this article, we analyze the AI Act’s impact...
Singapore’s Medical Device Regulations For medical device registrations, the Registrant is required to obtain a dealer’s license from the HSA, as only licensed medical device dealers are allowed to manufacture, import, or sell medical devices in Singapore. Applicants can apply for product registrati...