Latest! MDE Issues 13 Medical Device Q&A

Q1. If a new mandatory standard is issued in the product technical requirements, is it necessary to implement the mandatory standard before the product can be tested?

A: Since the new version of mandatory standards is released, enterprises can test according to the new version.

Q2. What are the requirements for the number of in vitro diagnostic reagents clinical trial institutions?

A: For products that need to undergo clinical trials, no less than 2 (including 2) clinical trial institutions should be selected for the Class II of in vitro diagnostic reagents, and no less than 3 should be selected for the class III or newly developed in vitro diagnostic reagents (including 3) clinical trial institutions that meet the requirements to conduct clinical trials.

Q3. How is mobile medical device defined?

A: Mobile medical devices refer to equipment and/or software that use non-invasive “mobile computing terminals” to achieve one or more medical purposes. Among them, “mobile computing terminal” refers to the mobile computing technology product terminal for personal use, including general (commercial ready-made) terminal and special (self-made medical) terminal. The use form can be divided into handheld (such as tablet computer, portable computer, smart phone, etc.)， wearable (such as smart glasses, smart watches, etc.) and hybrid (combination of handheld and wearable).

Q4. How to submit materials in foreign languages when submitting materials?

A: In accordance with the requirements for the format of medical device registration application materials and approval supporting documents (in vitro diagnostic reagents), all documents shall be provided in Chinese except the related documents. If the supporting documents are in a foreign language, the Chinese translation shall also be provided and signed and sealed by the agent. For the application materials translated according to the materials in foreign languages, the original text shall be provided at the same time.

Q5. Can the software components contained in the product be updated when continuing the registration?

A: According to The Guiding Principles for Technical Review of Medical Device Software Registration, if it is a slightly enhanced software update, a separate software update description document shall be submitted when continuing the registration; In case of corrective software update, the application materials for corrective software update shall be submitted when continuing the registration; If it is a major enhanced software update, the license shall be changed.

Q6. How to determine the applicable scope of ultrasonic soft tissue cutting hemostasis system?

A: The Guidelines for Registration Technology Review of Ultrasonic Soft Tissue Cutting Hemostasis System regulates the application scope of ultrasonic soft tissue cutting hemostasis system products, and stipulates that the scope of application is: ultrasonic soft tissue cutting hemostasis system products with functions of soft tissue cutting and blood vessel closure. Special requirements for cutting and closing blood vessels over 3mm are not included.

Q7.If the inner packaging form of colloidal gold products needs to be changed, wether the registration must apply for registration changes?

A. According to the requirements of Article 78 of Chapter V of The Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents (Order No. 48 ,NMPA), if the packaging specifications, product technical requirements and product instructions specified in the registration certificate have changed substantially, which belongs to the matters requiring change registration, the registrant shall apply to the original registration department for change registration procedures; if the inner packaging form of the product is not specified in the registration certificate and its attachments, it shall be filed with the original registration department within 30 days from the date of change.

That is, if the inner packaging form of the product is specified in the registration certificate and its attachments, when the registrant changes the inner packaging form of the product, he needs to apply to the original registration department for changing the registration procedures; If the inner packaging form of the product is not specified in the registration certificate and its attachments, it shall be filed with the original registration department within 30 days from the date of change.

Q8、When there are applicable national standards for in vitro diagnostic reagents, what issues should be concerned in product declaration?

A. When the in vitro diagnostic reagents have applicable national standards, the national standards should be used to test the reagents. If there is a new applicable national standard products released and implemented, the continuation of the registered products should also meet the requirements of the national standard products to be renewed.

Q9. GB 9706.1-2020 have been released, can enterprises choose to implement the new version of GB 9706.1 before the official implementation date?

A. According to Article 39 of The Measures for the administration of Mandatory National Standards, enterprises may choose to implement the original mandatory national standards or the new mandatory national standards after the issuance of mandatory national standards and before their implementation. After the implementation of the new mandatory national standards, the original mandatory national standards shall be abolished at the same time. Enterprises can choose to implement the new version of GB 9706.1 standard.

Q10. The company has passed ISO13485 certification and annual evaluation. Why does NMPC need to conduct on-site verification of production quality specifications when handling the production license of medical devices?

A. According to The Regulations on the Supervision and Administration of Medical Devices, the new start-up, change and continuation of the production of class II and class III medical devices are administrative licensing matters, and the production license shall be applied to the drug regulatory department of the people’s Government of the province, autonomous region and municipality directly under the central government. The Quality Management Practice for Medical Device Production and its appendices are the regulatory requirements that must be implemented by medical device manufacturers and are the basic conditions for obtaining production licenses.

ISO13485 standard is equivalent to YY / T0287 in China. It is a recommended industry standard for the quality management system of medical devices. The third-party certification institution implementing ISO13485 certification does not have the qualification of administrative license, and passing the third-party certification cannot be regarded as a necessary condition for listing license.

Q11.How should the independent exercise of authority by the quality department be reflected in the organizational structure? What are the requirements?

A.According to The Requirements of the Medical Device Production Quality Management Specification, the medical device manufacturer shall establish a quality management department, exercise its functions independently, and have the right to make decisions on matters related to product quality. The enterprise shall establish a special and independent quality management department under the direct jurisdiction of the top management or its authorized representative. The quality management department shall include the functions of QA and QC, and the specific functions shall be clearly specified in its responsibility documents according to the actual situation of the enterprise, such as quality management, quality control, quality inspection, product release, concession acceptance, quality audit, statistical analysis of quality data, nonconforming product control, internal audit, management review, etc. The quality authorized person shall be responsible for the release of products on the market, and the quality department shall have absolute and independent decision-making power on the product quality to ensure that each batch of raw materials, intermediate products and final products meet the quality requirements.

Q12. Products in the same registration unit contain reagents R1, R2, quality control products and calibrators, but their service life is different. How does the label mark the expiration date of the product?

A. If there are multiple components in the same registration unit, the shortest validity / expiration date of the components shall be the validity / expiration date of the registration unit, which shall be marked on the label.

Q13. If class II medical device innovation channel is intened to be applied for, how to know whether the current state of the product can apply for class II innovation?

A. According to the special examination procedure for class II innovative medical devices in Shanghai, class II innovative medical devices that meet the following conditions can be applied for:

（1）.The main working principle or action mechanism of the product is the first in China. The performance or safety of the product is fundamentally improved compared with similar products. It is at the domestic leading level in technology and has significant clinical application value.

（2）The applicant has completed the preliminary research of the product and has basical approveded product. The research process is true and controlled, and the research data is complete and traceable.

（3）Through its leading technological innovation activities, the applicant owns the invention patent right of product core technology in China according to law,or obtains the invention patent right or its use right in China through assignment according to law. The application time of special innovation examination shall not exceed 5 years from the date of patent authorization announcement; or the application for a patent for invention of core technology is made public by the Patent Administration Department of the State Council, and the patent search and consulting center of the State Intellectual Property Office issues search report, which indicates that the product’s core technology scheme has novelty and creativity; or the product technology is leading in China, which can fill the gap of this kind of medical devices.

If you need help on medical device registration in China, please feel free to contact us (info@inspirativemed.com) for any questions.

[Source:Tianjin MDE,Shanghai MDE]