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Health Food Raw Materials and Functions

WebOn 20.08.2019, the SAMR (State Administration for Market Regulation) announced that the health food regulatory framework will significantly change (No. 13-2019).

Actived: 6 days ago

URL: https://www.cisema.com/en/health-food-raw-materials-and-functions/

2020 Directory of Health Claims Approved for Health Food

Web2020 Directory of Health Claims Approved for Health Food Expanded. On December 1, 2020, the State Administration for Market Regulation (SAMR) issued (No.55 – 2020) the …

Category: Food Go Health

Cisema Health Food registration in China

WebMedical Device Entrusted Production now subject to enhanced supervision measures by China’s NMPA. 21 May 2024 in Medical Device, News, NMPA Registration in China. …

Category: Medical Go Health

2022 Draft List of Health Functions Allowed

WebFunctional Test and Evaluation Method of Health Food (2022 version) is a entirely new document. 24 kinds of health functions are suggested to be retained whilst the …

Category: Food Go Health

Guidelines for medical devices registration in China underway

Web32 existing guidelines for class II medical devices registration review are announced in the development plans. Some of these technical review guidelines cover: X-ray diagnostic equipment (class II) registration review guidelines. Electronic blood pressure monitor (oscillometric method) registration review guidelines.

Category: Medical Go Health

China health food with new functions

WebChina health food with new functions has new technical evaluation rules announced by the State Administration for Market Regulation (SAMR) on August 28, 2023, for trial …

Category: Food Go Health

China food regulatory updates in August 2023

WebChina health food regulatory updates were announced by the State Administration for Market Regulation (SAMR) on August 31, 2023, covering: Catalogue of health functions …

Category: Food Go Health

Digital Health Alert: 3 New China Regulatory Guidelines Released

WebDigital Health Alert: 3 New China Regulatory Guidelines Released. On March 9, 2022, the CMDE (Center for Medical Device Evaluation) of the NMPA (National Medical Products …

Category: Medical Go Health

China Clinical Trials for Drugs GMP appendix has been released

WebThe NMPA has supplemented the Good Manufacturing Practice (GMP) for Pharmaceutical Products (revised in 2010) with an Appendix on “GMP for Drugs for Clinical Trial”. The …

Category: Health Go Health

China new health food raw materials

WebChina adds new health food raw materials to the Catalogue of Health Food Raw Materials. The newly revised catalogue was released by the State Administration for Market …

Category: Food Go Health

New Regulation for Overseas Medical Devices in Hainan

WebOn June 2, the Hainan MPA announced (No.28 – 2020) the implementation of the new regulation to support the urgent clinical needs of medical device imports in Hainan’s …

Category: Medical Go Health

Importing Drugs and Medical Devices from Hong Kong to GBA

WebA total of 15 drugs and 5 medical devices have been approved so far for import into the GBA including the following drug and medical device approved in March 2022: Lorlatinib …

Category: Medical Go Health

China health food raw material update

WebNew China health food raw materials update. Two new raw materials, Soybean Protein Isolate and Whey protein, have been introduced for health food use. The documents …

Category: Food Go Health

China health food dual-use substances are added

WebChina health food dual-use substances catalogue has nine (9) new substances. These can be recognized as both food and Chinese medicinal materials in accordance with the …

Category: Food Go Health

China health food raw material technical requirements (Drafts)

WebChina health food raw material technical requirements have draft documents issued by the China State Administration for Market Regulation (SAMR) on July 5, 2023: Following the …

Category: Food Go Health

Drug registration in China

WebThe key points from the notice are: Applications for the domestic production of drugs that are currently manufactured abroad and marketed in China must be made by domestic applicants following the standard drug registration application requirements and procedures. Applicants can use the original registration materials of the foreign-produced

Category: Health Go Health

Medical Device Entrusted Production to enhanced supervision

WebMedical device entrusted production will be subject to enhanced supervision measures following an announcement by the National Medical Products Administration (NMPA) on April 3, 2024. This initiative follows the principles set out in the “Regulations on Supervision and Administration of Medical Devices” and aims to enforce the quality and

Category: Medical Go Health

China Clinical Application Management on Restrictive Medical

WebChina clinical application management is an important part of the modern hospital management system to standardize medical technologies and to ensure medical quality …

Category: Medical Go Health

Hong Kong new drug application expedited scheme starts on Nov 1

WebHong Kong new drug application – Expedited scheme to be launched on November 1, 2023. Hong Kong new drug application (NDA), fulfilling the conditional requirements set out by …

Category: Health Go Health

2022 Med Device Clinical Trial Requirements

WebIn March 2022, the National Medical Products Administration (NMPA) and National Health Commission (NHC) have released important updated clinical practice requirements for …

Category: Medical Go Health

Cisema Hong Kong MDACS Registration for MedTech

WebHong Kong has a unique regulatory system, the MDACS (Medical Device Administrative Control System). Unlike the NMPA registration in China, the listing of medical devices in …

Category: Medical Go Health

China drug standards draft measures published by NMPA

WebChina drug standards draft measures have recently been released by the National Medical Products Administration (NMPA). The aim of the drug standards measures is to help …

Category: Medical Go Health