Domestic Medical Device Registration Documentation: Authoritative Template (Active Devices)

2. Use Stability: Where applicable, submit documentation on use stability/reliability to demonstrate that, within the manufacturer-specified service life or number of uses, and under normal use, maintenance, and calibration (if applicable), the device’s performance and functionality meet intended requirements. No. 3.7.2: Packaging Validation Submit documentation on transportation stability and packaging validation to demonstrate that, under the manufacturer-specified transportation conditions, environmental factors encountered during transit—such as vibration, shock, and fluctuations in temperature and humidity—do not adversely affect the medical device’s characteristics and performance, including its integrity and cleanliness. No. 3.8: Other Documentation 1. Other Documentation: Additional research data substantiating the device’s safety and effectiveness. 2. For Class II medical devices exempt from clinical evaluation, if any of the changes described earlier occur—and such changes could potentially impact the device’s safety or effectiveness, or undermine the equivalence argument between the submitted device and those listed in the 'Catalogue of Medical Devices Exempt from Clinical Evaluation'—the applicant shall, per the 'Technical Guidance Principles for Comparative Statements for Devices Listed in the Catalogue of Medical Devices Exempt from Clinical Evaluation', demonstrate the device’s safety and effectiveness by comparing fundamental principles, structural composition, performance, safety, and intended use. For single-use devices, supporting documentation proving their non-reusability must also be provided. No. 4.1: Table of Contents The submission must include a table of contents listing all chapter titles and subheadings herein, specifying item numbers, titles, applicability status (indicating whether each CR section applies), uploaded file names, and corresponding page numbers; page numbers for all content sections within the table of contents must be clearly indicated. No. 4.2: Summary of Clinical Supporting Documents No. 4.2.1: Clinical Evaluation Documentation For devices requiring clinical evaluation, submit clinical evaluation documentation per applicable requirements. 1. Product Description and Development Background: Includes basic product information, intended use, current diagnostic or therapeutic methods and the clinical application of related medical devices, the relationship between the submitted product and existing diagnostic or therapeutic methods, and the anticipated clinical outcomes. 2. Clearly define the scope covered by the clinical evaluation. If any component of the submitted product is exempt from clinical evaluation, describe its structural composition and justify the exemption. 3. Clinical Evaluation Pathway: Select an appropriate clinical evaluation pathway—either a predicate-device comparison pathway and/or a clinical trial pathway—based on the product’s intended use, technical characteristics, and availability of existing clinical data. 4. If using the predicate-device comparison pathway, submit comparative data between the submitted device and the predicate device regarding intended use, technical features, and biological characteristics. Collect, assess, and analyze clinical data pertaining to the predicate device to generate clinical evidence. Where applicable, describe differences between the submitted device and the predicate device and provide sufficient scientific evidence demonstrating equivalent safety and effectiveness. No. 4.2.2: Clinical Trial Documentation If using the clinical trial pathway, submit the clinical trial protocol, clinical trial report, and a sample informed consent form, along with the clinical trial database (including the raw database, analysis database, descriptive documentation, and program code).

According to Article 165 of the Civil Code of the People’s Republic of China (2020), a power of attorney executed in writing must specify the following: Where agency authorization is made in writing, the power of attorney shall state the name (or title) of the agent, the matters entrusted, the scope of authority, and the duration of the agency, and shall be signed or sealed by the principal. 1. Name (or title) of the agent 2. Matters entrusted 3. Scope of authority 4. Duration of the agency 5. Signature or seal of the principal Pursuant to Article 62 of the Civil Procedure Law of the People’s Republic of China (2021): To entrust another person to represent one in litigation, a power of attorney signed or sealed by the entrusting party must be submitted to the people’s court. A power of attorney must clearly specify the entrusted matters and scope of authority. Special authorization from the entrusting party is required for a litigation agent to acknowledge, waive, or modify litigation claims; to reach a settlement; to file a counterclaim; or to appeal. A power of attorney sent or delivered from abroad by a Chinese citizen residing overseas must be certified by the People’s Republic of China’s embassy or consulate in that country. In countries where no such Chinese diplomatic mission exists, certification shall first be provided by the embassy or consulate of a third country maintaining diplomatic relations with the People’s Republic of China, and then authenticated by the People’s Republic of China’s embassy or consulate in that third country—or alternatively, certified by a local patriotic overseas Chinese association.

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