NMPA: Medical Device Classification Catalog adjusting (2023)

I. Adjustment Content

Adjustments have been made to the content of the Classification Catalog of Medical Devices involving 58 categories of medical devices. The specific adjustments are detailed in the appendix.

II. Implementation Requirements

(1) For the "Ulasonic Cutting and Hemostasis Blade, Ultrasonic Soft Tissue Surgical Blade, and Ultrasonic Aspirator Surgical Blade" classified as Class III medical devices under "01-01-03 Ultrasonic Surgical Device Accessories" and the "Breast Biopsy Needle and Accessories" under "01-10-06 Breast Biopsy System and Accessories" as mentioned in the appendix, starting from the date of this announcement, medical device registration applications will be accepted by medical device regulatory authorities in accordance with the adjusted classification, based on the Measures for the Administration of Medical Device Registration and Filing and the Announcement on the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents, among others.

For medical devices for which registration applications were accepted prior to the date of this announcement and for which registration approval (including initial registration and renewal registration) has not been completed, the medical device regulatory authorities will continue to review and approve them according to the original classification. For approved registrations, a medical device registration certificate will be issued, with the validity period limited to December 31, 2025, and the adjusted product management classification will be indicated in the remarks column of the registration certificate. For devices that have already obtained Class II medical device registration certificates, the registration certificates will remain valid until December 31, 2025. The relevant registrants shall actively carry out the conversion of the registration certificates in accordance with the requirements of the corresponding management classification and complete the conversion by December 31, 2025. If the original medical device registration certificate expires during the conversion process, and provided the product remains safe and effective with no serious adverse events or quality incidents post-market, the registrant may apply for an extension to the original approval authority under the original management attributes and classification. If approved, the validity period of the original medical device registration certificate shall not extend beyond December 31, 2025.

Starting from January 1, 2026, such products must not be produced, imported, or sold without legally obtaining a Class III medical device registration certificate. Relevant manufacturers shall切实 fulfill their responsibility for product quality and safety, ensuring the safety and effectiveness of marketed products.

(2) For other products covered by the adjustments, starting from the date of this announcement, medical device regulatory authorities will accept medical device registration applications or handle filings according to the adjusted classification, based on the Measures for the Administration of Medical Device Registration and Filing, the Announcement on the Requirements for Medical Device Registration Application Materials and the Format of Approval Documents, and the Announcement on Matters Related to the Filing of Class I Medical Devices, among others.

For medical devices for which registration applications have been accepted but registration approval (including initial registration and renewal registration) has not been completed, the medical device regulatory authorities will continue to review and approve them according to the original classification. For approved registrations, a medical device registration certificate will be issued, and the adjusted product management classification will be indicated in the remarks column of the registration certificate.

For registered medical devices whose management classification has been adjusted from Class III to Class II, the medical device registration certificate will remain valid within its validity period. If renewal is required, the registrant shall apply for renewal registration to the corresponding medical device regulatory authority six months before the expiration of the medical device registration certificate in accordance with the adjusted classification. For approved renewal registrations, a medical device registration certificate will be issued according to the adjusted product management classification.

For registered medical devices whose management classification has been adjusted from Class II to Class I, the medical device registration certificate will remain valid within its validity period. Before the registration certificate expires, the registrant may apply for product filing with the relevant authority.

If changes to the registration occur during the validity period of the medical device registration certificate, the registrant shall apply for change registration to the original registration department. If the original registration certificate was issued according to the original Classification Catalog of Medical Devices, the product management classification after the implementation of this announcement shall be indicated in the remarks column of the change registration document for the products involved in this announcement.

国家药监局关于调整《医疗器械分类目录》部分内容的公告（2023年第101号）