Announcement

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. …

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

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.

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 …

Update! Medical Devices Clinical Evaluation Exemption Catalogue Read More »

“Opinions on Further Strengthening the Supervision of Entrusted Production of Medical Device Registrants (Draft for Comment)”

Announcement, NMPA, NMPA News, Others / By

In order to fully implement the main responsibility for the quality and safety of medical device registrants, prevent and control the hidden risks of medical device entrusted production, and strengthen the supervision of medical device entrusted production, the State Food and Drug Administration organized the drafting of “Opinions on Further Strengthening the Supervision of Medical …

“Opinions on Further Strengthening the Supervision of Entrusted Production of Medical Device Registrants (Draft for Comment)” Read More »

Interpretation of medical device registration self-inspection management regulations

Announcement / By

The “Regulations on the Administration of Self-inspection of Medical Device Registration” organized by the State Drug Administration (National Drug Administration Announcement No. 126, which will come into force on the date of issuance, hereinafter referred to as the “Regulations”), has been issued on October 21, 2021. The background, main content and key issues of the …

Interpretation of medical device registration self-inspection management regulations Read More »

We Help You Enter China Market

We provide hands-on solutions to you! You are free from the frustration of not knowing China culture. 

Get Appointment