All medical devices have to be classified by the CFDA according to its risk in three classes. The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA). Address: No. NMPA has formulated,in conjunction with the National Health and Health Commission (NHC), the Regulations for the Administration of Drug Clinical Trial Institutions, which has been released on November 29, 2019, and shall take effect as from December 1, 2019. https://en.wikipedia.org/wiki/National_Medical_Products_Administration
When it was given jurisdiction over food in 2003, it was renamed the State Food and Drug Administration and reported to the State … CDISC standards are now the preferred standards for electronic data submission in China. China will give priority to the prevention of COVID-19 while deepening healthcare reform in the second half of this year, according to a document issued on July 23.Dalian, Liaoning province, will carry out nucleic acid testing for 190,000 people in areas related to confirmed cases and will expand to cover more where mobile transmission is possible, a senior government official said on July 23.Urumqi, capital of the Xinjiang Uygur autonomous region, has completed nucleic acid tests for more than 1 million people as of Tuesday since it began a free mass test campaign across the city on July 18, city officials said during a virus control and prevention conference on July 22.Copyright © Formulate the regulations on food administrative licensing and supervise their implementation; establish food safety risk management mechanism, formulate annual plans for nationwide inspection for food safety and programs for major control actions, and organize their implementation; establish the unified food safety information release system and release information on important food safety issues; participate in formulating food safety risk monitoring plans and food safety standards, and undertake food safety risk monitoring thereon; NMPA and NHC Issued Regulations for Administration of Medical Device Extended Clinical Trials (Interim) NMPA Issued the Announcement on Issues Pertaining to the Implementation of the Newly Revised Provisions for the Supervision and Administration of Drug Production; Regulatory Information. Establish food and drug emergency response system, organize and guide the emergency response and investigation on food and drug safety incident, and supervise the implementation of investigation and punishment; Austin, TX – 17 Dec 2019 – The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has released the requirements of clinical trial data submission in the electronic common technical document (eCTD) for public review in October. Announcement of NMPA on Revising the Package Inserts of hydrocortisone injection and … WikiProject China (Rated Start-class, High-importance) This article is within the scope of WikiProject China, a collaborative effort to improve the coverage of China related articles on Wikipedia. Organize the formulation and publication of the national pharmacopeia, other drug and medical device standards and classification system, and supervise their implementation; develop good practices on research, production, distribution and use of drugs and medical devices, and supervise their implementation; undertake drug and medical device registration, supervision and inspection; establish monitoring system for adverse drug reactions, adverse events of medical devices, and undertake monitoring and response activities; draw up and improve regulations and qualifications for licensed pharmacists, guide and supervise the registration work; participate in formulating national essential medicine list and assist its implementation; formulate administrative provisions for cosmetics administration and supervise their implementation;
Depending on the risk classification, different aspects are required: The In its first incarnation as the CFDA, the NMPA replaced a large group of overlapping regulators with an entity similar to the On 10 July 2007, Draft laws, regulations and rules and policy plans on the administration and supervision of food (including food additives and health food, the same below) safety, drugs (including traditional Chinese medicines and ethno-medicines, the same below), medical devices and cosmetics; formulate normative documents, and facilitate the establishment and implementation of the food safety responsibility mechanism, under which food companies shall bear the main responsibility and local people's governments shall take integrated responsibility; establish the direct reporting system for critical food and drug information and supervise its implementation; take measures to reduce risks on regional and systemic food and drug safety; Formulate the investigation and enforcement system for food, drugs, medical devices and cosmetics, and organize their implementation; organize the investigation and punishment on major violations; establish recall and disposal system for defect products, and supervise the implementation;