Novice medical device registration practitioners are often at their wits end in front of specific challenges. These challenges include searching for regulatory and technical evaluation criteria, executing specific processes, classifying and searching for devices, determining whether clinical evaluations or trials are necessary, and understanding the available paths for evaluation and consultation.

The Equipment Review Center provides publicly available information on these basic regulations, technical documents, and processes. By using the correct methods, practitioners can address their questions clearly and efficiently, thereby avoiding unnecessary detours and enhancing work efficiency.

This manual compiles relevant information from the Equipment Review Center, lists common problems, and provides query methods for reference by industry practitioners.

Determining the Classification of NO. 2 New Products

To determine the classification of medical devices, refer to the following documents and announcements:

Classification Rules for Medical Devices (Order No. 15 of the State Food and Drug Administration)

Classification Catalogue of Medical Devices (2017 No. 104)

Subsequent Classification-Related Normative Documents, such as:

Announcement on Adjusting Part of the "Classification Catalogue of Medical Devices" (2022 No. 25)

Announcement on the Management Categories of Medical Sodium Hyaluronate Products (2022 No. 103)

Announcement on the Publication of the Catalogue of First Class Medical Devices (2021 No. 158)

For in vitro diagnostic reagents, the classification is based on the Announcement on the Release of the "Classification Rules for In Vitro Diagnostic Reagents" (No. 129 of 2021), and other relevant catalogs such as:

"6840 In Vitro Diagnostic Reagent Classification Subcategory (2013 Edition)"

Adjustments to this subcategory (e.g., Announcement No. 112 of 2020)

Specific product classification adjustments (e.g., No. 226 of 2017)

For new products not included in the classification directory, you can search the "Classification Definition File Query" section on the Medical Device Standard Management Center's website for current effective classification definitions. If similar products have been classified, refer to those results. If no similar products exist, apply for classification and definition as per the Notice on Standardizing the Classification of Medical Device Products (Food and Drug Administration [2017] No. 127). If preliminarily classified as Class III, you may directly apply for Class III registration.

Registration and Application Process for NO. 3

For the registration and application process, consult the "Guidelines for Handling Matters" section on the Equipment Review Center's website. The "Registration and Application Process Diagram" provides a visual overview of the steps involved, available in both Chinese and English. Additional resources include: 

"Class I Filing Process Diagram" under the "Service Hall" for imported Class I products

"Declaration Process" under the "Enterprise Service" column of the "China Electronics Audit" official account

Required Documents for Registration Application of NO. 4

The registration declaration includes:

 Registration Declaration

Change Registration Declaration

Continuation Registration Declaration

Refer to:

Announcement No. 121 and 122 of 2021 for the required formats and approval documents.

Applicable guiding principles and evaluation points for technical requirements.

The Notice on Publishing the Folder Structure of the Electronic Application Catalog for Medical Device Registration (No. 15, 2021) for organizing application materials.

Comprehensive Technical Guidance for NO. 5

For specific product development and registration guidance:

Guiding Principles, Evaluation Points, and Standards:

Available on the Center for Market Regulation website under "Evaluation Science" and "Guiding Principles."

Example: Information for microwave surgical equipment.

Frequently Asked Questions:

Updated daily under the "Common Problems" and "Answering Questions and Resolving Questions" columns on the Center's website and official account.

Research Progress and Reflections:

Regular updates under "Review Forum" and "Information Disclosure" columns.

Publicity of Evaluation Reports:

First products of innovation and priority are open for public review under "Information disclosure - review report."

Consultation: 

Specific paths detailed in the relevant sections of the Center’s website and official account.

Guiding Principles for Preclinical Application Materials of NO. 6

General guiding principles include:

 Guiding Principles for Analytical Performance Evaluation (Qualitative and Quantitative Testing)

Guiding Principles for Reference Range Determination

Guiding Principles for Writing Instructions and Technical Requirements for In Vitro Diagnostic Reagents

Clinical Evaluation Pathway for NO. 7

To determine the clinical evaluation path:

 Refer to the "Clinical Evaluation Path Recommendation" section on the Medical Device Review Center's website.

Review the specific notices (No. 30, 24, and 20 of 2022) for detailed pathways.

For in vitro diagnostic reagents, refer to the Catalogue of In Vitro Diagnostic Reagents Exempted from Clinical Trials and follow the same variety comparison method or conduct clinical trials as required.

Conducting Clinical Trials for NO. 8

Medical Device Products:

Adhere to regulations like "Quality Management Standards for Clinical Trials of Medical Devices" and various technical guidelines.

In Vitro Diagnostic Products:

Follow guidelines such as the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents" and related documents.

Writing a Clinical Evaluation Report for NO. 9

Refer to the "Guiding Principles" under "Evaluation Science" on the Equipment Review Center's website, specifically:

Guiding Principles for Clinical Evaluation of Medical Devices

Guiding Principles for Decision Making on Clinical Trials

Technical Guidelines for Accepting Overseas Clinical Trial Data

Review Progress Follow-up for NO. 10

Use the "Progress Query" feature under "Enterprise Service" on the "China Certification Audit" official account or the website's "Service Hall."

"Product Tracking" feature on the "China Machine Review" official account to receive status updates via WeChat.

Note that the time limits specified are in working days unless otherwise stated.

The Equipment Review Center continues to deepen the reform of the evaluation system, continuously strengthen the construction of evaluation capabilities, and strive to shorten the time required for evaluation work. According to the statistical data of the center, the overall evaluation work of the Equipment Review Center in 2022 took an average of 72 working days for registration and evaluation of Class II products and 99 working days for registration and evaluation of Class III products, based on management categories; According to the application items, the overall average time for the initial registration review of the product is 95 working days, the change registration takes 64 working days, and the renewal registration takes 39 working days. The above time is the current statistical average time, for your reference.

It should be noted that the following time periods are not included in the relevant work deadlines mentioned above:

（1） The time taken by the applicant to supplement information, verify and rectify after verification;

（2） Delay in verification due to the applicant's reasons;

（3） The time required for external expert consultation, expert consultation meetings, and joint evaluation with drug review agencies for pharmaceutical device combination products;

（4） If the review and approval process is suspended according to regulations, the time occupied during the suspension of the review and approval process;

（5） The time occupied by quality management system verification.