On May 11, the State Food and Drug Administration issued the “Announcement on Standardizing the Classification and Definition of Medical Device Products” (hereinafter referred to as the “Announcement”) to further standardize the classification and definition of medical device products and optimize working procedures. The “Announcement” will be implemented from September 1, 2024.
The “Announcement” clarifies the positioning of classification definition work, the purpose and basis for carrying out classification work, the responsibilities of all parties involved in classification work, and other relevant content. The “Announcement” stipulates that the drug regulatory department shall provide medical device classification and definition services to medical device registration applicants and filers, and clearly define classification as a service matter.
The “Announcement” sets out the classification application definition path for newly developed medical devices and medical devices with doubtful management categories, and optimizes the work process and time limit requirements. For newly developed medical devices that have not yet been included in the “Classification Catalog” or medical devices whose management categories are questionable, if the drug regulatory department needs to clarify the classification definition opinions to apply for registration or filing, the applicant shall submit a classification definition application through the classification definition information system. The applicant should have completed preliminary research on the product, have a basic finalized product, and ensure that the classification definition application materials are legal, authentic, accurate, complete and traceable.
The “Announcement” points out that newly developed medical devices that have not yet been included in the “Classified Catalog” refer to medical devices that are brand new and have not yet been marketed in China, compared with the products in the “Classified Catalog” (comprehensive judgment based on product description, intended use and product name examples) and already marketed products, the main raw materials, production process, working principle, structural composition, usage method, contact parts and contact time, intended purpose, etc. Medical devices with doubtful management categories refer to medical devices where similar products have been marketed in my country or have been included in the “Classification Catalog”, but compared with similar products in the “Classification Catalog” or similar products that have been marketed, the main raw materials, production processes, working principles, structural composition, usage methods, contact parts and contact times, intended purposes, etc. of the product have changed, introducing new risks or increasing product risks, which may lead to changes in product classification.
The “Announcement” also stipulates the principle requirements for classification definition work in other situations such as product filing, product registration application acceptance, technical review, regulatory inspection, emergency public health emergencies, drug-device combination products, innovative medical devices and other situations.
The following is the original text of the announcement:
1. Regarding classification and definition work
(1) The drug regulatory department shall provide medical device classification and definition services to medical device registration applicants and filers. The classification and definition of medical devices is based on the information provided by the applicant and is determined by the drug regulatory authorities in accordance with the Regulations, Measures, Classification Rules for Medical Devices, Classification Rules for In Vitro Diagnostic Reagents (hereinafter collectively referred to as the Classification Rules), relevant classification definition guidelines, and the Medical Device Classification Catalog, Class I Medical Device Product Catalog, and In Vitro Diagnostic Reagents. “Diagnostic Reagents Classification Catalog” (hereinafter collectively referred to as the “Classification Catalog”), etc., based on the current scientific understanding and consensus, and with reference to international and domestic medical device classification practices, comprehensively considering the intended purpose, structural composition, usage, working principle and other factors of the medical device, evaluate the risk level of the medical device and determine the management category of the medical device.
(2) Applicants should determine product management attributes and categories based on the Regulations, Measures, Classification Rules, relevant classification definition guiding principles, and Classification Catalog. For newly developed medical devices that have not yet been included in the “Classification Catalog”, applicants can directly apply for product registration of Class III medical devices, or they can apply for product registration or product filing after judging the product category according to the “Classification Rules” and applying for classification definition.
For newly developed medical devices that have not yet been included in the “Classification Catalog” or medical devices whose management categories are questionable, if the drug regulatory department needs to clarify the classification definition opinions to apply for registration or filing, the applicant should submit a classification definition application through the classification definition information system. The applicant should have completed the preliminary research on the product, have a basic finalized product, and ensure that the classification definition application materials are legal, authentic, accurate, complete and traceable.
Newly developed medical devices that have not yet been included in the “Classified Catalog” refer to medical devices that are brand new and have not yet been marketed in China, compared with the products in the “Classified Catalog” (comprehensive judgment based on product description, intended use and product name examples) and already marketed products, the main raw materials, production process, working principle, structural composition, usage method, contact parts and contact time, intended purpose, etc.
Medical devices with questionable management categories refer to medical devices where similar products have been launched in my country or have been included in the “Classification Catalog”, but compared with similar products in the “Classification Catalog” or similar products that have been launched, the main raw materials, production processes, working principles, structural composition, usage methods, contact parts and contact times, intended purposes, etc. of the product have changed, introducing new risks or increasing product risks, which may lead to changes in product classification.
(3) For applications for classification definition of newly developed medical devices that have not yet been included in the “Classification Catalog”, the applicant shall submit the application to the Medical Device Standard Management Center of the State Food and Drug Administration (hereinafter referred to as the Device Standard Management Center) in the classification definition information system.
The Device Standardization Center is responsible for organizing research to clarify classification and definition opinions, informing applicants of the classification and definition results through the classification and definition information system, and adjusting the “Medical Device Classification Catalog” in a timely manner in accordance with procedures.
(4) For domestic medical device classification and definition applications with doubtful management categories, the applicant shall submit the application to the local provincial drug regulatory department in the classification and definition information system. Provincial drug regulatory departments are responsible for reviewing applications for product classification definition submitted by applicants within the administrative region. If the product management category can be clearly determined based on the Regulations, Classification Rules, relevant classification definition guidelines, and the Classification Catalog, the applicant will be notified of the classification definition results through the classification definition information system; if it is difficult to clearly determine the product management category, a pre-classification definition opinion will be proposed and reported to the Device Standardization Center through the classification definition information system.
The Device Standardization Center has established a communication and coordination mechanism for medical device classification with the Medical Device Technical Review Center of the State Food and Drug Administration (hereinafter referred to as the Device Review Center of the State Food and Drug Administration) and provincial drug regulatory departments to coordinate and guide the provincial drug regulatory departments in the definition of medical device classification.
For applications for classification definition of imported and Hong Kong, Macao and Taiwan product medical devices with doubtful management categories, the applicant shall submit them to the Device Standardization Management Center in the classification definition information system.
The Device Standardization Control Center is responsible for organizing research on applications for classification definition of imported and Hong Kong, Macao and Taiwan products medical devices with doubtful management categories and applications for classification definition of medical devices with pre-classification definition opinions issued by provincial drug regulatory authorities, clarifying classification definition opinions, and notifying applicants of classification definition results through the classification definition information system.
(5) The Medical Device Classification Technical Committee carries out classification and related work of medical devices (including in vitro diagnostic reagents) in accordance with the relevant provisions of the “Working Rules of the Medical Device Classification Technical Committee of the State Food and Drug Administration” to provide technical support for medical device classification management.
(6) Applicants, provincial drug regulatory authorities, medical device technical review departments at all levels, etc. can log in to the classification and definition information system to query the classification and definition results. The product classification definition results notified by the classification definition information system are only used when applying for medical device registration or filing; if the relevant content in the registered or filed product information (such as main raw materials, production process, working principle, structural composition, usage, contact parts and contact time, intended purpose, etc.) is inconsistent with the classification definition application information or classification definition application notification, the classification definition results are not applicable.
If the applicant has objections or questions about the result of product classification definition, he or she can communicate with the department notifying the result of classification definition. If there are still objections, the applicant can further improve the information and resubmit the application for classification definition.
2. Other situations involving product classification
(7) During the product filing, product registration application acceptance and technical review work, it is found that the product is not included in the “Classification Catalog” and other documents, and one of the following situations exists: first, the classification definition information system has not informed the classification definition results; second, the classification definition information system notifies the classification definition results, but the registration application materials or filing materials are inconsistent with the classification definition application materials, which may affect the product classification; third, if the applicant directly applies for product registration in accordance with the provisions of Article 23 of the Regulations regarding the registration of Class III medical device products, the following procedures shall be followed:
The medical device filing department or the registration application acceptance department determines the product management category in accordance with the Regulations, Classification Rules, relevant classification definition guidelines and the Classification Catalog. For products whose management category cannot be determined and has not yet been filed/has not yet accepted a registration application, the filing person/registration applicant shall submit a classification definition application through the classification definition information system with reference to newly developed medical devices that have not been included in the “Classification Catalog” or medical devices with doubtful management categories.
For products with doubts about the management category during the post-acceptance technical review stage, through the medical device classification communication and coordination mechanism, the Device Standardization Control Center will work with the Device Review Center of the State Food and Drug Administration or relevant provincial drug regulatory departments to study and determine the management category of the product. The Device Standardization Center should prioritize the issue of classification and definition of this situation.
(8) For special circumstances such as daily supervision, inspections, complaints and reports, petitions, administrative law enforcement, criminal justice, court cases, etc. that require confirmation of product management attributes or management categories, the procedures shall be handled in accordance with the classification and definition procedures of special circumstances. Product management attributes are determined based on Article 103 of the Regulations and relevant classification definition guidelines.
(9) For products that are needed to respond to public health emergencies and are not included in the “Classified Catalog” and for which the applicant, the drug regulatory department, and the technical review department have not reached an agreement on the management category, the Device Review Center of the State Food and Drug Administration and the provincial drug regulatory department will feedback to the Device Standardization Center through the classification communication and coordination mechanism. The Device Standardization Center will quickly study and define the product management attributes and management categories, and promptly feedback to the Device Review Center of the State Food and Drug Administration and the relevant provincial drug regulatory departments through the classification communication and coordination mechanism.
(10) The attributes of drug-device combination products shall be defined in accordance with the relevant regulations on drug-device combination products.
(11) Applications for product classification of innovative medical devices shall be handled in accordance with the relevant provisions of the special review procedures for innovative medical devices.
3. Other matters
(12) The Device Standardization Center is responsible for the construction and maintenance of the medical device classification definition information system and the medical device classification database. The Device Standardization Center establishes a coordination mechanism for medical device classification data sharing and promotes the sharing of classified information resources.
(13) The Device Standardization Center strengthens guidance on the classification and definition work of the provincial drug regulatory departments. If necessary, it can organize spot checks on the classification and definition results responded by the provincial drug regulatory departments. If the responses are inaccurate, the relevant provincial drug regulatory departments will be urged to make corrections.
In the case where different provincial drug regulatory authorities have different opinions on the classification and definition of the same type of product, the Device Standardization Center should promptly organize research to determine the management category and make it public. The relevant provincial drug regulatory authorities should promptly revise the notification of classification definition and promptly clean up and standardize registered/filed products in accordance with the relevant requirements of the State Food and Drug Administration.
(14) The Device Standardization Center shall timely sort out and summarize the classification and definition results and other information related to the classification of situations, refine and organize the classification and definition information and publish it regularly. The relevant product classification definition information is based on the information provided by the applicant, etc., and is an important guide for the registration application or filing process of medical device products, but it does not represent the recognition of the intended use of the product or the safety and effectiveness of the product; the product description and intended use in the classification definition information are used to determine the management attributes and management categories of the product, and do not represent a complete expression of the relevant product registration or filing content.
(15) For hot regulatory issues, common issues and issues that urgently need to be solved, the Device Standardization Center should study and refine the guiding principles for classification definition under the framework of classification rules, and unify the principles and standards for product classification definition in related fields.
(16) The Device Standardization Center shall dynamically adjust the Classification Catalog in a timely manner in accordance with the Working Procedures for Dynamic Adjustment of the Medical Device Classification Catalog and update the medical device classification database.