China Medical Device Industry Standards Issued by NMPA in July and October

China medical device industry standards were issued by the National Medical Products Administration (NMPA), detailing the release of revisions of 2 medical devices industry standards and one announcement that there are 36 medical devices industry standards have been approved by the NMPA in July 2024.On October 8, NMPA issued and announced 34 new medical device industry standards again. On July 8, 2024, the NMPA published the following industry standards revisions:

YY 0167-2020 Non-absorbable Surgical Sutures
YY 1116-2020 Absorbable Surgical Sutures.

Key Changes to YY 0167-2020 Non-absorbable Surgical Sutures

The revision of this standard was approved on July 1, 2024, and will be implemented one year after the issuance, providing a 12-month transition period. Two main technical aspects have been amended:Modification to Section 4.2.2 : The description of suture diameter measurements was updated. Previously, the standard referred to the average of each suture's diameter, but now it specifically states, "The average of the wire diameters shall be within the range of the average diameters of the corresponding specifications as specified in Table 2." This clarification helps ensure precise control over the thickness of sutures, addressing concerns about varying diameters in production.Changes to A.2.4 - Testing Procedures : The method of measuring thread diameter has been changed. The previous method, which took the average of three measurement points, has been replaced with a more thorough approach. The revised protocol now mandates testing 10 or 30 sutures with measurements taken at specific points, with multiple schemes outlined.

Key Changes to YY 1116-2020 Absorbable Surgical Sutures

Like the revisions made to YY 0167-2020, changes to YY 1116-2020 were also approved and are set for implementation in July 2025. The modifications focus on two main points:Modification to Section 4.2.2 : The update mirrors that of YY 0167-2020, adjusting the language to emphasize the average of the wire diameters rather than thread diameters, promoting precision in manufacturing. Revised Testing Methodology in A.2.4: The testing approach for absorbable sutures now parallels that of non-absorbable sutures. Manufacturers must perform point-by-point testing on 10 or 30 sutures, with specific schemes for different suture lengths. This change standardizes the quality assurance process across different suture types, ensuring that both absorbable and non-absorbable sutures are subject to rigorous testing.Wire Diameter Test ProgramprogramNominal length of suture (L) /cmNumber of test points on each stitchNumber of threadsnote1L ≤30130stitch230＜L ≤120210stitch3L＞120310Randomly selected sutures with 30 cm < L ≤ 120 cmIn addition to the suture standards, the NMPA also announced a new standard, YY 0117.1-2024, which focuses on "Surgical Implants Bone Joint Prosthesis Forgings and Castings Part 1: Ti6Al4V Titanium Alloy Forgings." This standard, along with 35 other medical device standards, was finalized and released under Announcement No. 92 of 2024.The new standards cover various medical devices and outline technical requirements, scope of application, and compliance timelines. Here are some examples of the medical device industry standard information table (No.92 2024).Reference No.NameStandard-setting or RevisionSubstitutesScope of applicationImplementation dateYY 0329—2024Single-use leukocyte removal filtersRevisionYY 0329—2009This document specifies the classification and naming, materials, requirements, marking and packaging of single-use leukocyte removal filters, and describes the corresponding test methods.July 20, 2027YY/T 1306—2024Fumigation therapy equipmentRevisionYY/T 1306—2016This document specifies the classification and requirements of fumigation therapeutic apparatus and describes the corresponding test methods.July 20, 2025YY/T 1754.4—2024Preclinical Animal Studies for Medical Devices Part 4: Acute Trauma Models for the Evaluation of Dressings for HealingSetting-standard/This document describes the preparation of an experimental porcine dorsal whole dermis acute trauma model. This document is applicable to the testing and evaluation of the pro-healing properties of wound dressings.July 20, 2025Examples of the medical device industry standard information table (No.120 2024)Reference No.NameStandard-setting or RevisionSubstitutesScope of applicationImplementation dateYY 0329—2024Single-use leukocyte removal filtersRevisionYY 0329—2009This document specifies the classification and naming, materials, requirements, marking and packaging of single-use leukocyte removal filters, and describes the corresponding test methods.July 20, 2027YY/T 1306—2024Fumigation therapy equipmentRevisionYY/T 1306—2016This document specifies the classification and requirements of fumigation therapeutic apparatus and describes the corresponding test methods.July 20, 2025YY/T 1754.4—2024Preclinical Animal Studies for Medical Devices Part 4: Acute Trauma Models for the Evaluation of Dressings for HealingSetting-standard/This document describes the preparation of an experimental porcine dorsal whole dermis acute trauma model. This document is applicable to the testing and evaluation of the pro-healing properties of wound dressings.July 20, 2025

Implications for Regulatory Affairs Managers

Regulatory affairs managers with products registered in China must prepare for the implementation of these updated standards. The transition period provides time to adjust manufacturing and quality control processes to comply with the new requirements.Coordination with product development teams, third-party manufacturers, and testing facilities will be essential to meet the updated standards before the July 2025 deadline.