Summary of Recent Q&A: on the Division of Registration Units, the List of Exemptions from Clinical Evaluation
Source: CMDE
Q. What is the requirement for the inspection report of medical device submitted for the registration application or filing？
A. According to the Requirement of Administration Measures for Registration and Filing of Medical Device and Administration Measures for Registration or Filing of IVD Regents，the inspection report of medical device submitted for the purpose of registration or filing can be the self-inspection report of the applicant and filer or the inspection report，or can be the inspection report issued by a entrusted qualified inspection institute.
Among them，for the tings like completed self-inspection and partial self-inspection+ partial entrusted inspection ,it should be carried out in accordance with the Requirement of the Regulation on the management of Self-inspection of Medical Device Registration. Report on the application for registration or filing shall be submitted according to the “Article IV. Requirement for Material application” in the Provision on the self-inspectio registration of medical device.
i.Inspection report issued by qualified inspection institution of medical device.
ii. If an overseas registration applicant entrusts an agent within China to conduct the entrusted inspection, it shall state in the power of attorney of the designated agent in China that the entrusted agent “shall, in accordance with the product technical requirements of the product to be registered, entrust a qualified medical device inspection institution within the territory of China to inspect the product to be declared and registered”, and the corresponding contents shall be specified in the agent’s letter of commitment.
iii. the aboved materials shall be signed or sealed by the registration applicant or agent, and the document format shall comply with the annex 4 of the Announcement on publishing the requirement of registration and declaration material of medical device and the approval certificate (No.121,2021)
Q. How to divide registration unit of dentisty handphone？
A. According to the requirement for division of registration unit， if product has big difference in
Technical principal，structure composition，performance index and range of application shall be divided into different registration unit.
Referred to above principal：
i． High-speed gas turbine handpiece, dental curved handpiece/dental straight handpiece shall be divided into different registration unit.
ii．Dental handpiece/ handpiece， holding a root canal file for enlarging the root canal of a tooth in a dental straight handpiece，handpiece used for the treatment of oral implantology，Handpieces for teeth drilling and grinding shall be divided into different registration unit.
iii．Cell phones with illuminated device type versus those without lighting should be divided into different registration units; Light guiding versus light free handpieces belong to same registration unit.
Q. What’s the precautions for Bland-Altman analysis of quantitative determinationresult in IVD regent ？
A. Bland-Altman analysis is generally used to evaluate the uniformity paired quantitative testresult。In Bland-Altman analysis of the quantitative determinationresult in IVD regent， the uniformity limit is not only calculated in line with the deviation value of the test result，but also set appropriate acceptable standard in line with clinical requirement，and evaluate wether uniformity limit is within the acceptable range. The setting of clinical acceptable standard should have a reasonable basis .
Q. How to understand the non-exemption of infusion products in the exemption from clinical evaluation catalogue?
A. The catalog stipulates that exemption does not include the product with new material ，mechanism of action and new function. New materials, new mechanism of action, new function only refers to materials, mechanism of action, and function that have not been used in the domestic similar infusion appliances.
In the aspect of new material，such as for infusion line PVC raw materials, it is already in use in a similar class of marketed products. The infusion appliances made of totm plasticizer PVC raw materials，doesn‘t belong to the aspect of new material，and can be free of clinical evaluation of product。
In the aspect of mechanism of action，if the infusion set adopts floating body type or membrane type liquid stop component，this same component has already been used in similar marketed products. When applying for registration, the mechanism of action does not belong to the category of new mechanism of action, and the clinical evaluation of the product can be exempted.
In the aspect of new function，such as the transfusion needle with anti-needle stick function，It does not belong to the category of new functions when applying for registration, and the clinical evaluation of the product can be exempted.
Q.What needs to be stated in the in vitro diagnostic reagent specification [product performance specification]?
A. The full analytical performance evaluation and clinical trial results of the product need to be stated in the in vitro diagnostic reagent specification [product performance measures]. For in vitro diagnostic reagents exempt from clinical testing, the results of their clinical evaluation are stated.
BradyKnows has seasoned staff in registration and can help manufacturers on legal compliance. If you have any questions, please feel free to contact us info@bradyknowsmedical.com for more information.
