On July 8, China NMPA issued the first modification of YY 0167-2020 “The absorbable surgical sutures” and YY 1116-2020 “Absorbable surgical sutures”. Contact us for modification details.
On February 7, 2024, China NMPA released 20 Medical Device Industry Standards including YY 1001-2024 “All Glass Syringe”. The following is the detail information: No. Standard No. Title Status Scope of application Effective Date 1 YY 1001—2024 All glass syringes Revised This document specifies the structural type, materials, requirements, marking, packaging, transportation and storage of …
On September 5, 2023, the China State Food and Drug Administration issued an announcement on 45 medical device industry standards including YY0304-2023 “Plasma Sprayed Hydroxyapatite Coated Titanium Dental Implants” (2023 No. 118). For more information, please contact us by email info@gvmmedical.com.
NMPA published its mandatory YY standards and recommended YY standards modification plan on May 23, 2023 (Refer to Notification 17-2023). Below are some of the standards: Cardiopulmonary diversion system：Disposable arteriovenous cannula (YY 0948-2015, ISO 18193:2021) Single-use hollow fiber blood filter ( YY 0465-2019, ISO 8637-3:2018 ) Medical Electrical Equipment Part 2-87: Specific requirements for basic …
In accordance with the requirements of the “Notice of the General Department of the State Food and Drug Administration on Printing and Distributing the Work Plan for the Implementation of GB 9706.1-2020 and Supporting Parallel Standards and Special Standards”, in order to fully understand the bottom line, the China Inspection Institute has made statistics as …
2023 Medical device mandatory industry standard formulation and revision project plan serial number Standard Item Name standard nature revision was revised Standard adopt international Standard Responsible unit (Standard Committee/Technical Coordinator unit) 1 Medical Electrical Equipment Part 2-87: Particular Requirements for Basic Safety and Essential Performance of High Frequency Ventilators mandatory formulate / ISO 80601-2-87:2021 National …
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Recently, the State Food and Drug Administration issued the “Notice on the Implementation of GB 9706.1-2020 and its supporting parallel standards and special standards” (No. 14 of 2023, hereinafter referred to as the “Notice”). The background and relevant content of the announcement are hereby explained as follows: 1. Background GB 9706.1-2020 and supporting parallel standards …
1. For products registered before the date of implementation of GB 9706.1-2020 and supporting parallel standards and special standards (hereinafter referred to as the new version of GB 9706 series standards), how to continue the registration? The “Notice on the Implementation of GB 9706.1-2020 and Supporting Collateral Standards and Special Standards” (No. 14 of 2023, …
On May 24, the General Department of the NMPA issued a notice on printing and distributing the 2023 medical device industry standard formulation and revision plan: In order to implement the “Implementation Opinions on Comprehensively Strengthening the Construction of Drug Supervision Capabilities” issued by the General Office of the State Council and the relevant requirements …
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The new version of GB/T 14233.1 was released Recently, GB/T 14233.1-2022 “Medical Infusion, Blood Transfusion, and Injection Equipment Test Methods Part 1: Chemical Analysis Methods” (hereinafter referred to as “the new version of GB/T 14233.1”) was released and will be officially implemented on November 1, 2023. GB/T 14233.1 is one of the series of standards …
