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The NMPA is responsible for registration of medical devices for the Chinese market. All medical devices have to be classified by the CFDA according to its risk in three classes. Depending on the risk classification, different aspects are required: For medical devices of class I: product tests are sometimes required; For medical devices of class ...
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
In 1999, the Medicines Control Agency (MCA) took over control of the General Practice Research Database (GPRD) from the Office for National Statistics. The Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was rebranded as the Clinical Practice Research Datalink (CPRD).
The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section 226) of 2007 .
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
First Databank (FDB) is a major provider of drug and medical device databases that help inform healthcare professionals to make decisions. [1] FDB partners with information system developers to deliver useful medication- and medical device-related information to clinicians, business associates, and patients.
However, the findings are “not surprising,” according to Jasmin Dao, M.D., Ph.D., neurologist at Miller Children’s & Women’s Hospital Long Beach and MemorialCare Long Beach Medical Center.
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.