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Medical Devices
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Guideline on Market Access for Medical Device in China is a report drafted by CIRS Group- Medical Device BU to help companies and individuals who would like to sell their medical devices to the People’s Republic of China and get their medical device products registered with NMPA. The guide describes key definitions, main regulations, authorities of the medical devices in China, and also the requirements of the whole life-cycle of medical devices including pre-registration preparatioin, registration process, testing/inspection, clinical evaluation, QMS and post-market management.
On April 16, 2021, the National Medical Products Administration released the "Guiding Principles for the Classification and Definition of Radio Frequency Beauty Products" for comments on the solicitation of "Guidelines for the Classification of Radio Frequency Beauty Products". According to the definition of the properties of the draft, it claims that radio frequency beauty can reduce spots and wrinkle. Such equipment is classified as medical device management. Medical devic
Adverse events (AE) refer to unfavorable medical events that occur during clinical trials, regardless of whether they are related to experimental medical devices. A serious adverse event (SAE) refers to a death or serious deterioration in health that occurs during a clinical trial, including fatal diseases or injuries, permanent defects in body structure or body function, requiring hospitalization or prolonged hospitalization, and the need to undergo Medical or surgical inte
Q: How to determine the servicelife of active medical devices? what factors should be considered? A: The manufacturer should dynamically evaluate the service life of the product through risk analysis in the whole life cycle of the product. When there is no unacceptable risk within the service life of the product after listing, the expected service life determined before listing can be maintained; or the expected service life determined before listing can be extended after re
Q: What are the requirements for adding models or accessories in the Change of Permission Items? A: The contents contained in one registration certificate shall comply with the requirements of "Guidance of registrtaion units division for medical device". Whether it is able to add models or accessories into the registration certificate of registered products depends on the difference between the new model and the original model, as well as the relevance between the new access
In 2020, the National Bureau conducted unannounced inspections on 89 medical device manufacturers, including 44 IVD companies, 16 sterile product companies, 11 active device companies, 9 implant product companies, 3 denture companies, and 3 independent software company and 3 other companies. The reasons for unannounced inspections are compliance inspections, special inspections, unqualified random inspections, complaints and reports, and occurrence of adverse events. The res
1. Q: Imported active medical device includes a variety of configurations when marketed in original country, but only part of the configurations was seleted when submitting in China. will it be accepted? A: When imported medical devices is submitted registration in China, the scope of application of the medical device shall not exceed the scope when approved in the orginal country. If only part of the configuration is submitted, and the submitted part can be applied independ
1. Product Overview of Disposable Ligation Clip Disposable ligation clips are also called closed clips. They are often injection molded from polymer materials (such as POM). They are placed on a base with a cover, wrapped in a PET blister box and dialysis paper, and then sterilized by ethylene oxide. Whether the material is degradable is divided into non-absorbable and absorbable ligature clips, which are used for one time. It is mainly used to clamp blood vessels to stop bl
The "Regulations on the Supervision and Administration of Medical Devices" were formulated in 2000, and were fully revised and partially revised in 2014 and 2017. It has played an important role in ensuring the quality and safety of medical devices and promoting the healthy development of the industry. On 17th of March , the newly revised "Regulations on the Supervision and Administration of Medical Devices" was officially released and will be implemented on 1st of June, 2021
According to the medical device review requirements, various researches are required during the registration and application of medical device products, such as material chemical characterization, stability, process research, etc. When conducting medical device product research, some items, especially the chemical characterization of materials, are closely related to raw materials, and it is often necessary to obtain information on the composition and process of raw materials during research. Due to the need for technical confidentiality, it is difficult for medical device raw material suppliers to provide this information to medical device manufacturers in detail, which creates certain difficulties for the research on the final product of medical devices. At the same time, for medical devices that use the same raw materials, some research projects are the same. Research by the medical device manufacturer on its own also causes a waste of resources and the problem of repeated submissio