On July 8, 2024, the National Medical Products Administration (NMPA) issued Announcement No. 83 of 2024, releasing amendments to two important industry standards for medical devices: YY 0167-2020 "Non-absorbable Surgical Sutures" and YY 1116-2020 "Absorbable Surgical Sutures." These amendments have been reviewed and approved and are intended to update and refine the respective standards to align with current medical needs and technological advancements.
According to the NMPA announcement, these amendments were approved on July 1, 2024, and will take effect 12 months from the date of publication. This provides relevant medical device companies and institutions with a transition period to adjust and update their standards and operational procedures to comply with the new regulations.
The revision of these standards aims to enhance the quality and safety of both non-absorbable and absorbable surgical sutures, fostering continuous improvement in China's medical device industry standards and further aligning them with international practices. Industry professionals and organizations are encouraged to stay informed and adapt to these changes to ensure high-quality and safe medical devices, thus providing better protection for patients.
MEDTECH NEWS
NMPA Announces Amendments to YY 0167-2020 and YY 1116-2020 Industry Standards for Medical Devices
08 07 2024On July 8, 2024, the National Medical Products Administration (NMPA) announced amendments to the YY 0167-2020 and YY 1116-2020 standards for non-absorbable and absorbable surgical sutures, respectively. Effective 12 months from approval on July 1, 2024, these updates aim to enhance the quality and safety of surgical sutures, aligning with both current medical needs and international standards.