In order to strengthen the classification management of medical devices, further standardize the classification identification of medical devices, and optimize relevant work procedures, according to the Regulations on the Supervision and Administration of Medical Devices (“the Regulations”), the Measures for the Administration of Registration and Filing of Medical Devices and the Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents (“the Measures”), the Opinions on Further Strengthening and Improving the Classification Management of Medical Devices and other related requirements, the relevant matters are hereby notified as follows:
I. Classification Identification
(I) The drug supervision and administration departments shall provide classification definition services of medical devices for the registration and filing applicants of medical devices. The classification identification of medical devices is to evaluate the degree of risk of medical devices and then determine the management categories of medical devices by the drug supervision and administration departments, on the basis of the materials provided by the applicant, according to the Regulations, the Measures, the Rules for Classification of Medical Devices and the Rules for Classification of In Vitro Diagnostic Reagents (“the Classification Rules” collectively), relevant guiding principles for classification identification, and the Medical Device Classification Catalog, the Class I Medical Device Product Catalog and the Classification Catalog of In Vitro Diagnostic Reagents (“the Classification Catalogs”), based on current scientific knowledge and consensus, by reference to international and domestic practices in medical device classification, and with full consideration of the intended purpose, structure, usage and working principle and other factors of medical devices.
(II) The applicant shall determine the management attributes and categories according to the Regulations, the Measures, the Classification Rules, relevant guiding principles for classification identification, the Classification Catalogs and so forth. For newly developed medical devices that have not been listed in the Classification Catalogs, the applicant may either apply for registration as Class III medical devices, or apply for product registration or filing after the determination of the product category according to the Classification Rules and the application for classification identification.
For newly developed medical devices that have not been listed in the Classification Catalogs or whose management categories are doubtful, for which reason definite classification identification opinions are required from the drug supervision and administration departments to apply for registration or filing, the applicant shall file an application for classification identification in the classification identification information system. The applicant shall have accomplished the preliminary research on the product and finalized the designed product, and shall ensure that the application materials for classification identification are legal, true, accurate, complete and traceable.
The newly developed medical devices that have not been listed in the Classification Catalogue refer to the medical devices, whose main raw materials, production process, working principle, structure, usage, contact position and time, and intended purpose are all new when compared with the products in the Classification Catalogs (based on the product description, intended purpose and product name given as examples) and the products already on the market and which have not been marketed in China.
The newly developed medical devices whose management categories are doubtful refer to the medical devices, whose main raw materials, production process, working principle, structure, usage, contact position and time, and intended purpose have changed, which introduces new risks or increases the product risk or may lead to the change in product classification, when compared with similar products that have been marketed in China or listed in the Classification Catalogs.
(III) For newly developed medical devices that have not been listed in the Classification Catalogs, the applicant shall submit the application for classification identification to the Center for Medical Device Standard Management of National Medical Products Administration (Hereinafter referred to as Center for Medical Device Standard Management) via the classification identification information system.
The Center for Medical Device Standard Management shall organize the study on the applications for classification identification and form definite opinions, and inform the applicant of the classification identification results via the classification identification information system, and shall adjust the Medical Device Classification Catalog in a timely manner according to relevant procedures.
(IV) For domestic medical devices whose management categories are doubtful, the applicant shall submit the application for classification identification to local provincial drug supervision and administration department via the classification identification information system. The provincial drug supervision and administration department shall review the application for classification identification filed by the applicant; where the management category can be determined according to the Regulations, the Classification Rules, relevant guiding principles for classification identification, the Classification Catalogs and so forth, the department shall inform the applicant of the classification identification results via the classification identification information system; where the management category cannot be determined, preliminary classification identification opinions can be put forward and reported to the Center for Medical Device Standard Management via the classification identification information system.
The Center for Medical Device Standard Management shall establish a communication and coordination mechanism for the classification of medical devices with the Center for Medical Device Evaluation of National Medical Products Administration (“Center for Medical Device Evaluation”) and provincial drug supervision and administration departments, and provide overall guidance for provincial drug supervision and administration departments in the classification identification of medical devices.
For imported and Hong Kong, Macao and Taiwan medical devices whose management categories are doubtful, the applicant shall submit the application for classification identification to the Center for Medical Device Standard Management of via the classification identification information system.
The Center for Medical Device Standard Management shall organize the study on the applications for classification identification of imported and Hong Kong, Macao and Taiwan medical devices, whose management categories are doubtful, and of medical devices, on which provincial drug supervision and administration departments issue preliminary classification identification opinions, form definitive opinions, and inform the applicant of the classification identification results via the classification identification information system.
(V) The Technical Committee on Classification of Medical Devices shall carry out the classification and relevant work of medical devices (including in vitro diagnostic reagents) according to the requirements of the Working Rules for the Technical Committee on Classification of Medical Devices of National Medical Products Administration, to offer technical support for the classification management of medical devices.
(VI) The applicant, provincial drug supervision and administration departments, medical device evaluation departments at all levels and so forth may log in to the classification identification system to query for the classification identification results. The classification identification results in the classification identification information system are for use in the application for registration or filing of medical devices only; in case of any discrepancy between the registration or filing materials (in such aspects as main raw materials, production process, working principle, structure, usage, contact position and time, and intended purpose) and the application materials or the notice of application for classification identification, the classification identification results shall not be applicable.
In the event of any objection against or question about the classification identification results received, the applicant may communicate with the department that informs the applicant of the classification identification results. If the objection remains, the applicant may provide further materials and submit an application for classification identification again.
II. Other circumstances involving product classification
(VII) Where the any product is found not listed in the Classification Catalogs and other documents during the acceptance of filing and registration applications and the technical evaluation of product and in one of the following circumstances, the procedures below shall be followed: first, the classification identification results are not issued via the classification identification information system; second, the classification identification results are issued via the classification identification information system, but the application materials for registration or filing are inconsistent with the application materials for classification identification, which may affect the product classification; third, the applicant directly applies for product registration according to the requirements concerning the registration of Class III medical devices under Article 23 of the Regulations.
The filing department or registration acceptance department of medical devices shall determine the management categories according to the Regulations, the Classification Rules, relevant guiding principles for classification identification, the Classification Catalogs and so forth. For products, for which the management categories cannot be determined and the filing or registration applications have not been accepted, the applicant shall file an application for classification identification in the classification identification information system in the same manner as for newly developed medical devices that have not been listed in the Classification Catalogs or medical devices whose management categories are doubtful.
For products, whose management categories are doubtful at the stage of technical evaluation, the Center for Medical Device Standard Management shall study and determine the management categories together with the Center for Medical Device Evaluation of National Medical Products Administration or relevant provincial drug supervision and administration departments through the communication and coordination mechanism for the classification of medical devices. The Center for Medical Device Standard Management shall give priority to the classification identification issues under such circumstance.
(VIII) Where the management attributes or categories of products should be confirmed under such special circumstances as daily regulation, audit, complaint and report, petition, executive law enforcement, criminal justice and court case, the classification identification procedures for special circumstances shall be followed. The management attributes shall be determined according to Article 103 of the Regulations and relevant guiding principles for classification identification.
(IX) For products that are required to deal with public health emergencies and have not been listed in the Classification Catalogs, and for which no agreement has been reached between the applicant and the drug supervision and administration department and the technical evaluation department on the management categories, the Center for Medical Device Evaluation of National Medical Products Administration and relevant provincial drug supervision and administration department shall report to the Center for Medical Device Standard Management through the classification communication and coordination mechanism, and the latter shall study and define the management attributes and categories quickly, and feed back to the Center for Medical Device Evaluation of National Medical Products Administration and the provincial drug supervision and administration department through the classification communication and coordination mechanism.
(X) The attributes of drug-device combination products shall be defined according to the requirements concerning drug-device combination products.
(XI) The products submitted for classification as innovative medical devices shall be classified according to the requirements in the special review procedures for innovative medical devices.
III. Miscellaneous
(XII) The Center for Medical Device Standard Management shall be responsible for the establishment, maintenance and so forth of the classification identification information system and classification database of medical devices. The Center for Medical Device Standard Management shall establish a coordination mechanism for sharing the classification data of medical devices and promote the sharing of classification information and resources.
(XIII) The Center for Medical Device Standard Management shall strengthen the guidance on the classification identification of provincial drug supervision and administration departments, and when necessary, may organize spot checks on the classification identification results obtained in the reply from provincial drug supervision and administration departments; where the reply is inaccurate, the Center for Medical Device Standard Management shall urge relevant provincial drug supervision and administration department to make corrections.
When no agreement is reached on the classification identification of same product category among different provincial drug supervision and administration departments, the Center for Medical Device Standard Management shall organize a timely study on it to determine and make public the management category; relevant provincial drug supervision and administration departments shall revise its notice of classification identification and standardize the registered/filed products in time according to the requirements of National Medical Products Administration .
(XIV) The Center for Medical Device Standard Management shall promptly sort out and summarize the classification identification results and the classification related information under other circumstances, extract and refine them into classification identification information and publish it on a regular basis. Relevant classification identification information is based on the materials provided by the applicant, which offers important guidance in the registration application or filing process of medical devices, but it does not represent recognition for the intended purpose or the safety and efficacy of product. The product description and intended purpose included in the classification identification information are used for determining the management attribute and category of a product, but not represent a complete statement of its registration or filing details.
(XV) As for hot, common and urgent issues on regulation, the Center for Medical Device Standard Management shall study and refine the guiding principles for classification identification under the framework of classification rules, and unify the principles and measures for classification identification of products in relevant fields.
(XVI) The Center for Medical Device Standard Management shall make dynamic adjustments to the Classification Catalogs in a timely manner according to the Working Procedure for Dynamic Adjustment of Medical Device Classification Catalog, and update the classification database of medical devices.
This Announcement shall be implemented since September 1, 2024. The former Circular on Standardizing the Classification of Medical Devices issued by the General Office of China Food and Drug Administration (SYJBXG [2017] No. 127) shall be abolished simultaneously.
National Medical Products Administration
May 10, 2024
Source: National Medical Products Administration (NMPA)
I. Classification Identification
(I) The drug supervision and administration departments shall provide classification definition services of medical devices for the registration and filing applicants of medical devices. The classification identification of medical devices is to evaluate the degree of risk of medical devices and then determine the management categories of medical devices by the drug supervision and administration departments, on the basis of the materials provided by the applicant, according to the Regulations, the Measures, the Rules for Classification of Medical Devices and the Rules for Classification of In Vitro Diagnostic Reagents (“the Classification Rules” collectively), relevant guiding principles for classification identification, and the Medical Device Classification Catalog, the Class I Medical Device Product Catalog and the Classification Catalog of In Vitro Diagnostic Reagents (“the Classification Catalogs”), based on current scientific knowledge and consensus, by reference to international and domestic practices in medical device classification, and with full consideration of the intended purpose, structure, usage and working principle and other factors of medical devices.
(II) The applicant shall determine the management attributes and categories according to the Regulations, the Measures, the Classification Rules, relevant guiding principles for classification identification, the Classification Catalogs and so forth. For newly developed medical devices that have not been listed in the Classification Catalogs, the applicant may either apply for registration as Class III medical devices, or apply for product registration or filing after the determination of the product category according to the Classification Rules and the application for classification identification.
For newly developed medical devices that have not been listed in the Classification Catalogs or whose management categories are doubtful, for which reason definite classification identification opinions are required from the drug supervision and administration departments to apply for registration or filing, the applicant shall file an application for classification identification in the classification identification information system. The applicant shall have accomplished the preliminary research on the product and finalized the designed product, and shall ensure that the application materials for classification identification are legal, true, accurate, complete and traceable.
The newly developed medical devices that have not been listed in the Classification Catalogue refer to the medical devices, whose main raw materials, production process, working principle, structure, usage, contact position and time, and intended purpose are all new when compared with the products in the Classification Catalogs (based on the product description, intended purpose and product name given as examples) and the products already on the market and which have not been marketed in China.
The newly developed medical devices whose management categories are doubtful refer to the medical devices, whose main raw materials, production process, working principle, structure, usage, contact position and time, and intended purpose have changed, which introduces new risks or increases the product risk or may lead to the change in product classification, when compared with similar products that have been marketed in China or listed in the Classification Catalogs.
(III) For newly developed medical devices that have not been listed in the Classification Catalogs, the applicant shall submit the application for classification identification to the Center for Medical Device Standard Management of National Medical Products Administration (Hereinafter referred to as Center for Medical Device Standard Management) via the classification identification information system.
The Center for Medical Device Standard Management shall organize the study on the applications for classification identification and form definite opinions, and inform the applicant of the classification identification results via the classification identification information system, and shall adjust the Medical Device Classification Catalog in a timely manner according to relevant procedures.
(IV) For domestic medical devices whose management categories are doubtful, the applicant shall submit the application for classification identification to local provincial drug supervision and administration department via the classification identification information system. The provincial drug supervision and administration department shall review the application for classification identification filed by the applicant; where the management category can be determined according to the Regulations, the Classification Rules, relevant guiding principles for classification identification, the Classification Catalogs and so forth, the department shall inform the applicant of the classification identification results via the classification identification information system; where the management category cannot be determined, preliminary classification identification opinions can be put forward and reported to the Center for Medical Device Standard Management via the classification identification information system.
The Center for Medical Device Standard Management shall establish a communication and coordination mechanism for the classification of medical devices with the Center for Medical Device Evaluation of National Medical Products Administration (“Center for Medical Device Evaluation”) and provincial drug supervision and administration departments, and provide overall guidance for provincial drug supervision and administration departments in the classification identification of medical devices.
For imported and Hong Kong, Macao and Taiwan medical devices whose management categories are doubtful, the applicant shall submit the application for classification identification to the Center for Medical Device Standard Management of via the classification identification information system.
The Center for Medical Device Standard Management shall organize the study on the applications for classification identification of imported and Hong Kong, Macao and Taiwan medical devices, whose management categories are doubtful, and of medical devices, on which provincial drug supervision and administration departments issue preliminary classification identification opinions, form definitive opinions, and inform the applicant of the classification identification results via the classification identification information system.
(V) The Technical Committee on Classification of Medical Devices shall carry out the classification and relevant work of medical devices (including in vitro diagnostic reagents) according to the requirements of the Working Rules for the Technical Committee on Classification of Medical Devices of National Medical Products Administration, to offer technical support for the classification management of medical devices.
(VI) The applicant, provincial drug supervision and administration departments, medical device evaluation departments at all levels and so forth may log in to the classification identification system to query for the classification identification results. The classification identification results in the classification identification information system are for use in the application for registration or filing of medical devices only; in case of any discrepancy between the registration or filing materials (in such aspects as main raw materials, production process, working principle, structure, usage, contact position and time, and intended purpose) and the application materials or the notice of application for classification identification, the classification identification results shall not be applicable.
In the event of any objection against or question about the classification identification results received, the applicant may communicate with the department that informs the applicant of the classification identification results. If the objection remains, the applicant may provide further materials and submit an application for classification identification again.
II. Other circumstances involving product classification
(VII) Where the any product is found not listed in the Classification Catalogs and other documents during the acceptance of filing and registration applications and the technical evaluation of product and in one of the following circumstances, the procedures below shall be followed: first, the classification identification results are not issued via the classification identification information system; second, the classification identification results are issued via the classification identification information system, but the application materials for registration or filing are inconsistent with the application materials for classification identification, which may affect the product classification; third, the applicant directly applies for product registration according to the requirements concerning the registration of Class III medical devices under Article 23 of the Regulations.
The filing department or registration acceptance department of medical devices shall determine the management categories according to the Regulations, the Classification Rules, relevant guiding principles for classification identification, the Classification Catalogs and so forth. For products, for which the management categories cannot be determined and the filing or registration applications have not been accepted, the applicant shall file an application for classification identification in the classification identification information system in the same manner as for newly developed medical devices that have not been listed in the Classification Catalogs or medical devices whose management categories are doubtful.
For products, whose management categories are doubtful at the stage of technical evaluation, the Center for Medical Device Standard Management shall study and determine the management categories together with the Center for Medical Device Evaluation of National Medical Products Administration or relevant provincial drug supervision and administration departments through the communication and coordination mechanism for the classification of medical devices. The Center for Medical Device Standard Management shall give priority to the classification identification issues under such circumstance.
(VIII) Where the management attributes or categories of products should be confirmed under such special circumstances as daily regulation, audit, complaint and report, petition, executive law enforcement, criminal justice and court case, the classification identification procedures for special circumstances shall be followed. The management attributes shall be determined according to Article 103 of the Regulations and relevant guiding principles for classification identification.
(IX) For products that are required to deal with public health emergencies and have not been listed in the Classification Catalogs, and for which no agreement has been reached between the applicant and the drug supervision and administration department and the technical evaluation department on the management categories, the Center for Medical Device Evaluation of National Medical Products Administration and relevant provincial drug supervision and administration department shall report to the Center for Medical Device Standard Management through the classification communication and coordination mechanism, and the latter shall study and define the management attributes and categories quickly, and feed back to the Center for Medical Device Evaluation of National Medical Products Administration and the provincial drug supervision and administration department through the classification communication and coordination mechanism.
(X) The attributes of drug-device combination products shall be defined according to the requirements concerning drug-device combination products.
(XI) The products submitted for classification as innovative medical devices shall be classified according to the requirements in the special review procedures for innovative medical devices.
III. Miscellaneous
(XII) The Center for Medical Device Standard Management shall be responsible for the establishment, maintenance and so forth of the classification identification information system and classification database of medical devices. The Center for Medical Device Standard Management shall establish a coordination mechanism for sharing the classification data of medical devices and promote the sharing of classification information and resources.
(XIII) The Center for Medical Device Standard Management shall strengthen the guidance on the classification identification of provincial drug supervision and administration departments, and when necessary, may organize spot checks on the classification identification results obtained in the reply from provincial drug supervision and administration departments; where the reply is inaccurate, the Center for Medical Device Standard Management shall urge relevant provincial drug supervision and administration department to make corrections.
When no agreement is reached on the classification identification of same product category among different provincial drug supervision and administration departments, the Center for Medical Device Standard Management shall organize a timely study on it to determine and make public the management category; relevant provincial drug supervision and administration departments shall revise its notice of classification identification and standardize the registered/filed products in time according to the requirements of National Medical Products Administration .
(XIV) The Center for Medical Device Standard Management shall promptly sort out and summarize the classification identification results and the classification related information under other circumstances, extract and refine them into classification identification information and publish it on a regular basis. Relevant classification identification information is based on the materials provided by the applicant, which offers important guidance in the registration application or filing process of medical devices, but it does not represent recognition for the intended purpose or the safety and efficacy of product. The product description and intended purpose included in the classification identification information are used for determining the management attribute and category of a product, but not represent a complete statement of its registration or filing details.
(XV) As for hot, common and urgent issues on regulation, the Center for Medical Device Standard Management shall study and refine the guiding principles for classification identification under the framework of classification rules, and unify the principles and measures for classification identification of products in relevant fields.
(XVI) The Center for Medical Device Standard Management shall make dynamic adjustments to the Classification Catalogs in a timely manner according to the Working Procedure for Dynamic Adjustment of Medical Device Classification Catalog, and update the classification database of medical devices.
This Announcement shall be implemented since September 1, 2024. The former Circular on Standardizing the Classification of Medical Devices issued by the General Office of China Food and Drug Administration (SYJBXG [2017] No. 127) shall be abolished simultaneously.
National Medical Products Administration
May 10, 2024
Source: National Medical Products Administration (NMPA)