News

China's generative AI interim measures came into effect on August 15, 2023, after National Internet Information Office's approval in May 2023.

China medical device classification catalogue updates pertain to 58 categories of medical devices and encompass changes in product descrip...

The catalogue of medical devices exempted from clinical evaluation was recently revised by China NMPA and came into effect on July 24, 2023.

Third batch of illegal and non-compliant medical device online sales with 6 cases in total reported in China by the NMPA on August 4, 2023.

China medical device benefit-risk assessment guidelines have been revised and released by the CMDE on July 18, 2023.

New cosmetic ingredients filed for China registration marks a significant milestone as the count scales up to 77 since 2021.

China's new toothpaste regulations are set to be implemented starting from December 1, 2023. Reach out to Cisema for English translations.

Hong Kong medical device listing now attains full prominence in public tenders with measures effective from June 21, 2023, onwards.

Capturing the Medical Technology potential Chinese market - the upcoming Cisema webinar will be held on September 12, 2023, at 9am CET

Cisema will be exhibiting at the highly anticipated RAPS Convergence 2023 from October 3-5, 2023. Visit us at booth 502!

Inspection report of Jiangxi Meilin Kangda Pharmaceutical in China was issued by the NMPA on July 19, 2023 with QMS concerns being reported.

Ultrasound AI and AI analysis software in China have four guidance documents released by the CMDE on July 10, 2023.

Testing methods for Azelaic acid and other cosmetics raw materials in China have been proposed by the NIFDC on July 12, 2023.

China health food raw material technical requirements have drafts issued in July 2023, focusing on Soybean Protein Isolate and Whey Protein

Quality management of medical device business operations in China has a new draft regulation issued by the China CMDE on June 1, 2023.

Clinical evaluation of ventilators has new technical review guidelines issued by the China NMPA on July 10, 2023

Illegal and non-compliant medical device online sales for up to 6 cases were reported in China by the NMPA on June 30, 2023.

A registration review guideline for clinical evaluation of spinal fusion devices issued by the Center for Medical Device Evaluation (CMDE).

20 new industry standards for medical devices have been approved recently by the National Medical Products Administration (NMPA).

Pressure piping components type test regulation (TSG D7002-2023) has been revised by the China State Administration for Market Regulation.