The British Chamber has partnered with LexisNexis to bring you key policy updates from the Chinese government each week, in the sectors that matter to British businesses in China. From awareness of regulations and policies that affect foreign ...
The British Chamber has partnered with LexisNexis to bring you key policy updates from the Chinese government each week, in the sectors that matter to British businesses in China. From awareness of regulations and policies that...
BSI Medical Devices provides quality management reviews and CE certifications for medical device manufacturers around the world, and we can do it for you too.
BSI understands its obligations for impartiality, including defining its impartiality policy and is committed to mitigating any risk to impartiality for the services it provides. This also includes a review of its impartiality risk analysis at least once a year. BSI has formal rules and/or contractu...
Risk management file: Should include Provides secure and centralized repository for all documents in risk documentation of policy for determining acceptable management file, making search and retrieval easy. Through the risks, risk management plan, results of risk analysis, Organizer tool, documents can...
policy framework for health technology . medical device regulations . health technology assessment . health technology management . needs assessment of medical devices . medical device procurement . medical equipment donations . medical equipment inventory management . medical equipment maintOrganization, World...
qualitypolicyandquality objectivesofthemanufacturingenterprises; (two)organizing,planninganddefiningtheproduct realizationprocesstoensurethatcustomerrequirementsare met; (three)ensurethehumanresources,infrastructureandworking environmentneededfortheeffectiveoperationofthequality managementsystem; (four)organizemanagementreview...
This chapter examines the robust growth in medical device regulation in China, which has accompanied the growth of the industry and the increasing level of medical technology approved for use in health care in China. It discusses the general procedures and requirements for pre-market approval and ...
In practice, one side might control the board of directors, but not be able to effectively enact meaningful decisions over the venture because they neglected key management positions. 13 Chinese Medical Device Industry | China for China strategy Figure 6 below shows the trend in domestic and ...
Only the justification requirement for the use of an in-house produced device still needs to become applicable on 26 May 2028. While the MDCG has issued guidance (MDCG 2023-1) on the subject, this guidance is really broad in some areas and shows divergence in policy (or absence thereof)...