In order to better guide the filing administration of Class I medical devices, according to the Regulation on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council) and the Rules for the Classification of Medical Devices (Order No. 15 of the China Food and Drug Administration, hereinafter referred to as Order No. 15), the National Medical Products Administration (“NMPA”) has organized revision of and issued the Class I Medical Device Product Catalog (hereinafter referred to as the new Class I Catalog), which will come into force on January 1, 2022. To do a good job in implementing the new Class I Category, the related matters are hereby notified as follows:
I. General description of the new Class I Catalog
(I) The new Class I Catalog takes the 2017 edition of Medical Device Classification Catalog as the main framework, includes the 19 sub-catalogs, 119 first-level product categories, 368 second-level product categories, and 2,629 product name examples in the 2017 edition of Medical Device Classification Catalog, and increases 90 pieces of product information and 538 product name examples compared to the 2017 edition of Medical Device Classification Catalog.
(II) The general expression of product descriptions and intended uses of Class I medical devices in the new Class I Catalog does not represent the full expression of the filing content of related products. Product management categories should be determined in combination with product reality and according to product descriptions, intended uses, and product name examples in the new Class I Catalog.
(III) The new Class I Catalog increases the annex, List of Ingredients Prohibited from Adding to Some Class I Medical Devices, to stipulate that the “09-02-03 physical cooling equipment”, “09-03-08 phototherapy equipment accessory”, “14-10-02 adhesive bandage” and “20-03-11 acupoint pressure stimulation instrument” products in the new Class I Catalog shall not contain traditional Chinese medicines, chemical drugs, biological products, disinfection and antibacterial ingredients, natural plants and their extracts, or other ingredients that have pharmacological, immunological or metabolic effects or can be absorbed by the human body, including but not limited to the ingredients in the annex’s table, so as to further regulate the filing of related products.
(IV) The new Class I Catalog excludes in vitro diagnostic reagents. The management category of in vitro diagnostic reagents shall be determined according to the Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents (Order of State Administration for Market Regulation (No. 48), hereinafter referred to Order No. 48), the Announcement on Releasing the Rules for Classification of In Vitro Diagnostic Reagents (Announcement No. 129 [2021] of the National Medical Products Administration, hereinafter referred to as Announcement No. 129), and the related in vitro diagnostic reagent classification catalog, and the classification code thereof continues to be 6840.
(V) The new Class I Catalog excludes package products. Package products are products composed of more than one type of medical device for combined use to achieve a certain intended use. The management category of package products shall be determined according to the related provisions of Order No. 15, Order No. 48, and Announcement No. 129.
(VI) The new Class I Catalog will come into force on January 1, 2022, following which, the Notice on Releasing the Class I Medical Device Product Catalog (Notice No. 8 [2014] of the China Food and Drug Administration), the Notice of the General Office of the China Food and Drug Administration on Matters Concerning the Implementation of Filing of Class I Medical Devices (SYJBXG [2014] No. 174), and medical device classification determination documents issued before 2016 shall all be abolished. Any inconsistency between the 2017 edition of Medical Device Classification Catalog & previous classification determination results and the new Class I Catalog shall be subject to the new Class I Catalog.
II. Policy on filing administration of medical devices
(VII) Class I medical devices shall all be filed according to the new Class I Catalog from January 1, 2022.
For products filed before January 1, 2022, if some products shall still be administered as Class I medical devices according to the new Class I Catalog but their filing information form content and filed product technical requirements are inconsistent with the new Class I Catalog, the filing entities shall complete filing information changes before April 1, 2022 or request the cancellation of the original filing and process again Class I medical device filing with the original filing authorities.
(VIII) If a product management category cannot be determined according to the new Class I Catalog, classification determination shall be applied for according to the medical device classification determination workflow, and if the product is confirmed as a Class I medical device, the filing entity can process filing according to the classification determination result and the related provisions.
(IX) The Class I Catalog shall be timely updated and adjusted according to medical device production, operation, use, etc., based on medical device risk analysis and evaluation, and with reference to the Medical Device Classification Catalog Dynamic Adjustment Work Procedures.
According to the unified arrangements of the NMPA, provincial medical products administrations should organize training in the new Class I Catalog within their administrative areas and supervise and guide related entities’ implementation of the new Class I Catalog and shall timely study and handle problems encountered in the implementation of the new Class I Catalog and timely report them to the NMPA.
It is hereby announced.
Source: National Medical Productions Administration
I. General description of the new Class I Catalog
(I) The new Class I Catalog takes the 2017 edition of Medical Device Classification Catalog as the main framework, includes the 19 sub-catalogs, 119 first-level product categories, 368 second-level product categories, and 2,629 product name examples in the 2017 edition of Medical Device Classification Catalog, and increases 90 pieces of product information and 538 product name examples compared to the 2017 edition of Medical Device Classification Catalog.
(II) The general expression of product descriptions and intended uses of Class I medical devices in the new Class I Catalog does not represent the full expression of the filing content of related products. Product management categories should be determined in combination with product reality and according to product descriptions, intended uses, and product name examples in the new Class I Catalog.
(III) The new Class I Catalog increases the annex, List of Ingredients Prohibited from Adding to Some Class I Medical Devices, to stipulate that the “09-02-03 physical cooling equipment”, “09-03-08 phototherapy equipment accessory”, “14-10-02 adhesive bandage” and “20-03-11 acupoint pressure stimulation instrument” products in the new Class I Catalog shall not contain traditional Chinese medicines, chemical drugs, biological products, disinfection and antibacterial ingredients, natural plants and their extracts, or other ingredients that have pharmacological, immunological or metabolic effects or can be absorbed by the human body, including but not limited to the ingredients in the annex’s table, so as to further regulate the filing of related products.
(IV) The new Class I Catalog excludes in vitro diagnostic reagents. The management category of in vitro diagnostic reagents shall be determined according to the Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents (Order of State Administration for Market Regulation (No. 48), hereinafter referred to Order No. 48), the Announcement on Releasing the Rules for Classification of In Vitro Diagnostic Reagents (Announcement No. 129 [2021] of the National Medical Products Administration, hereinafter referred to as Announcement No. 129), and the related in vitro diagnostic reagent classification catalog, and the classification code thereof continues to be 6840.
(V) The new Class I Catalog excludes package products. Package products are products composed of more than one type of medical device for combined use to achieve a certain intended use. The management category of package products shall be determined according to the related provisions of Order No. 15, Order No. 48, and Announcement No. 129.
(VI) The new Class I Catalog will come into force on January 1, 2022, following which, the Notice on Releasing the Class I Medical Device Product Catalog (Notice No. 8 [2014] of the China Food and Drug Administration), the Notice of the General Office of the China Food and Drug Administration on Matters Concerning the Implementation of Filing of Class I Medical Devices (SYJBXG [2014] No. 174), and medical device classification determination documents issued before 2016 shall all be abolished. Any inconsistency between the 2017 edition of Medical Device Classification Catalog & previous classification determination results and the new Class I Catalog shall be subject to the new Class I Catalog.
II. Policy on filing administration of medical devices
(VII) Class I medical devices shall all be filed according to the new Class I Catalog from January 1, 2022.
For products filed before January 1, 2022, if some products shall still be administered as Class I medical devices according to the new Class I Catalog but their filing information form content and filed product technical requirements are inconsistent with the new Class I Catalog, the filing entities shall complete filing information changes before April 1, 2022 or request the cancellation of the original filing and process again Class I medical device filing with the original filing authorities.
(VIII) If a product management category cannot be determined according to the new Class I Catalog, classification determination shall be applied for according to the medical device classification determination workflow, and if the product is confirmed as a Class I medical device, the filing entity can process filing according to the classification determination result and the related provisions.
(IX) The Class I Catalog shall be timely updated and adjusted according to medical device production, operation, use, etc., based on medical device risk analysis and evaluation, and with reference to the Medical Device Classification Catalog Dynamic Adjustment Work Procedures.
According to the unified arrangements of the NMPA, provincial medical products administrations should organize training in the new Class I Catalog within their administrative areas and supervise and guide related entities’ implementation of the new Class I Catalog and shall timely study and handle problems encountered in the implementation of the new Class I Catalog and timely report them to the NMPA.
It is hereby announced.
National Medical Products Administration
December 30, 2021
Source: National Medical Productions Administration