FAQ

A: According to Article 16 of Regulations on the Administration of Instruction and Label of Medical Devices, when an approved medical device is changed, the applicant should amend the instruction and label on his own according to the approved change document. If the changed contents of instruction is not specified in the registration certificate and its attachments, which is not within the scope of change registration, it should be notified in writing to the approval department for medical device registration, and submit relevant documents including comparison statement on the change of the instruction.

A: For most medical devices (non-in vitro diagnostic reagents), the stability and validity period of various properties of the product usually depend on the raw materials used in the product and the aging mechanism of the materials, such as thermal aging, photo aging, etc. As long as the raw material properties, production process and packaging materials of the product remain stable, in principle, the differences between batches should not affect the performance stability and validity period of the product. Therefore, in general, batches do not need to be considered when conducting performance studies. If the product has special characteristics, such as containing biologically active substances, the impact of batch-to-batch variation on product performance can be considered.

A: It should be analyzed whether the changes of the product technical specifications and other contents described in the Registration Certificate are involved. If so, a change of registration should be applied. If not, a change of registration should not be required and only relevant work should be done according to the requirements of the enterprise’s quality management system (OMS).

A: If the medical device registration certificate needs to be renewed after the expiration of the validity period, the registrant should apply for the renewal of registration 6 months before the expiration of the medical device registration certificate, and follow the submit application materials as required. If the application materials are incomplete or do not conform to the statutory form and need to be supplemented and corrected, our center will indicate the time of the registrant’s first application for renewal of registration in the notification of acceptance of corrections. When the registrant applies for renewal of registration again after making corrections, he should submit the notice of acceptance of supplements and corrections. The Center For medical Device Evaluation. NMPA will determine whether the application for renewal of registration is within 6 months after the expiration of the validity period of the medical device registration certificate according to the time of the registrant’s first application for renewal of registration indicated in the notice of acceptance of supplements and corrections, and review the application materials in accordance with the provisions of the Administrative Measures for Registration and Filing of Medical Devices.

A: In this case, the original registered product can be selected as the predicate device for clinical evaluation. Attention should be mainly paid to whether there is any difference between the proposed product and the original registered product in comparison with the predicate device. If there is no difference between the two products, the clinical data to be provided may include the pre-marketing and post-marketing clinical data of the product, and the clinical experience data including post-marketing adverse events.

A: According to the requirements of Article 14 of the Administrative Measures for Registration and Filing of Medical Devices and Article 15 of the Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents, overseas administrative counterparts and filing parties should designate a legal person in China as an agent, handle the registration and filing of related medical devices/in vitro diagnostic reagents. The agent should assist the administrative counterparts and the filing parties in fulfilling the obligations stipulated in the first paragraph of Article 20 of the Regulations on the Supervision and Administration of Medical Devices, and assist the overseas administrative counterparts and filing people to implement the corresponding legal responsibilities. According to the above representative requirements, the resident representative office or office of the foreign administrative counterpart in China cannot act as an agent.

A: According to the Notice by CMDE on the implementation of Provisions for Medical Device Registration and Filing, Provisions for In-vitro Diagnostic Reagent Registration and Filing, the medical devices produced in China by overseas enterprises should be registered or filed as domestic medical devices, with domestic manufacturers as applicants. For imported medical devices that obtained the registration certificate, please refer to the Announcement (No. 104 of 2020) by NMPA to submit application materials.

A: If the registration applicant does not have the ability to inspect all or part of the items in the product technical requirements applicants can entrust the relevant items to one or more qualified medical device inspection institutions for inspection. The registration applicant should ensure the consistency of the inspection samples that are entrusted. (For product technical requirements that fully adopt national standards or industry standards, the inspection agency must obtain the qualification certification of the national standard or industry standard, and the cover of the report should be stamped with the qualification certification mark CMA seal, and the national standards or industry standards should be indicated in the report remarks. If the inspection does not involve or partially involves national standards or industry standards, the inspection capability should be self-declared in the remarks of the inspection report, and the corresponding legal responsibility should be assumed.) When submitting a registration application, the registration applicant should form a self-inspection report according to the results of the entrusted inspection, and all the entrusted inspection reports should be submitted as attachments to the self-inspection report.

A: The administrative counterparts should complete the remark column in the application form of the special review for innovative medical device as per below requirements: the administrative counterpart should truthfully fill in the information of experts/units that related to the relevant interests, including but not limited to physical and chemical index testing, biological performance testing, animal testing, clinical trials, the cooperative researchers, the intellectual property buyers and sellers, etc., and specify the experts that applying for avoidance and state the reasons for their avoidance. If there are experts related to the interests, the name of the specific enterprise and the specific R&D project in which the experts are involved should be specified. The remark column should not be blank, “None” can be filled if there is no relevant content.

A: First of all, the initial consideration of the relevant provision in this standard is to solve the problem whether a device can work normally while meeting the voltage fluctuations that may occur when used in China. Second, the nominal voltage range of the device is only the rated voltage that it claims to be able to support, which is not the same point as the previous one, so there are no contradictions between the two parameters. Therefore, for the situation described in the question, the submission of registration should be accordance with the actual design of the product, which means the nominal voltage range in the “Product Technical Requirements” should be based on the actual design parameter as 100-240V, and the electrical safety and electromagnetic compatibility testing should also be carried out in accordance with the nominal voltage range at 100240V. While for the testing of the specific provision in industry standard, it should meet the power supply range of 220V±22V.

A: If a certain part of the product composition of a medical device is necessary to achieve its intended use and basic function.it cannot be considered as an “optional accessory”. If the surgical device is expected to be optional and users could choose different models to achieve different functions, it can be submitted registration in the form of “optional accessories”. Purchasing one or part of the surgical instruments separately or not does not affect the safety and efficacy of the overall use of the product. Whether the surgical instrument is declared in the form of optional accessories or not, the technical review requirements are the same, and all the instruments need to be declared in the product structure and composition.

A: Catalogue of Medical Devices Exempted from Clinical Evaluation stipulates that exemptions do not include new materials, new mechanisms of action or new functions including conditions that have not been used in the same type of infusion devices on the market in China. (1) New materials, such as TOTM plasticizer for PVC raw material of infusion set pipeline, have been used in similar products on the market. Infusion sets made of TOTM plasticizer PVC raw materials do not belong to the category of new materials and can be exempted from clinical evaluation of the product. (2) New mechanism of action, such as infusion device using floating or membrane type liquid stop components, and the same components have been used in similar products on the market. When applying for registration, the mechanism of action does not belong to the category of new mechanism of action, which can be exempted from clinical evaluation of the product. (3) In terms of new functions, for example, infusion needle has the function of preventing puncture, and the same function has been used in similar products on the market, which does not belong to the category of new functions when applying for registration, and can be exempted from clinical evaluation of this product.

A: Theoretically, the temperature of the real-time stability study of the product is generally the same as the storage temperature. If some products have special regulations, the relevant regulations will be implemented first. For example, GB/T 11417.8 Ophthalmic optics—Contact lenses—Part 8: Determination of shelf-life, the standard clearly stipulates that the temperature used in the stability study of contact lens products is 25. However, for general medical devices stored at room temperature, if there are no special regulations, in principle, the real-time stability verification temperature is not mandatory to be performed at 25°C +2°C, and corresponding research data can be provided according to product characteristics. For medical devices with special requirements for storage temperature, verification research should be carried out according to the specified temperature.