Notice on the classification definition of “degradable expandable hemostatic sponge” products 

Announcement, NMPA, NMPA News / By

Release date: 2023.12.06   In order to further clarify the management attributes and categories of “degradable expandable hemostatic sponge” products,  the China NMPA notice as follows:   1. “degradable expanding hemostatic sponge” products are polyether-type polyurethane sponges, which are composed of (DL-lactide-co-ε-caprolactone)-urethane copolymer and are disposable. Products have been sterilized by irradiation and should be sterile. …

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Single photon emission and X-ray computed tomography imaging system approved by China NMPA

NMPA News / By

Recently, the innovative product Single Photon Emission and X-ray Computed Tomography Imaging System of Beijing Novel Medical Equipment Ltd. is approved by China NMPA. This product consists of a single photon emission computed tomography (SPECT) host (including two SPECT detectors), CT host frame, examination bed, PDU server, acquisition client workstation, SPECT acquisition server workstation, CT …

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Revocation of YY 0569-2011 and YY/T 0687-2008

Announcement, NMPA / By

On October 23, 2023，NMPA announcement No. 135 [2023], NMPA has decided abolished YY 0569-2011 “Class II Biological Safety Cabinet” and YY/T 0687-2008 “Surgical Instruments – Non-cutting Articulated Instruments – General Technical Conditions” two medical device industry standards.

GB 9706.1-2020 Standards Interpretation

Interpretation, NMPA / By

This article is focus on how to deal with the renewal of existing registrations, the adoption of new and recommended standards, and the modification of product instructions and labels. 1. Renewal of Existing Registrations: If medical devices applying for registration renewal can’t meet the new mandatory standards, the renewal will not be granted. Existing registrations …

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YY standards

NMPA Mandatory and Recommended YY Standards

NMPA, Standard / By

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 …

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Clinical Evaluation

Guidelines – Clinical Evaluation of the Powered Laser Surgical Instrument

Guidelines, NMPA / By

The guidance document was released on July 26, 2023. It’s the NMPA current thinking about the clinical evaluation of the Powered Laser Surgical Instrument. This guideline applies to powered laser surgical instruments intended to reduce human hair and wrinkles, treat hyperpigmented skin diseases and skin vascular diseases, and treat scars (Product Code 09-03-01, Class III). …

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China medical device

Some content adjustments in the “Medical Device Classification Catalogue”

Medical Device Catalogue / By

In order to further deepen the reform of the medical device review and approval system, based on the actual development and supervision of the medical device industry, and in accordance with the relevant requirements of the “Regulations on the Supervision and Administration of Medical Devices” and the “Dynamic Adjustment Work Procedures for the Classification of …

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Medical Devices Clinical Evaluation

Update! Medical Devices Clinical Evaluation Exemption Catalogue

Announcement / By

On July 24, the NMPA issued the catalog of medical devices exempt from clinical evaluation: In order to do a good job in the management of medical device registration, according to the “Measures for the Administration of Medical Device Registration and Filing” (State Administration of Market Regulation No. Circular No. 71 of 2021), which is …

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