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Cisema Partners with LifeSciences BC
Cisema Partners with LifeSciences BC

LifeSciences BC is a industry association that supports and represents the life sciences community of British Columbia in Canada.

March 29, 2022
Cisema Partners with LifeSciences BC
China Regulatory Round-up for Health Food from November 2020 to January 2021

The National Health Commission announced new food ingredients and additives are permitted to be used in food-contact articles.

China Regulatory Round-up for Health Food from November 2020 to January 2021
On-site Inspection Measures for Special Food Products in China

On November 26, 2020, the SAMR announced the temporary measures for on-site inspection on special food products in China.

On-site Inspection Measures for Special Food Products in China
5 Raw Materials Added to the Health Food Raw Materials Directory

Five health food ingredients to be filed according to the directory and technical requirements for raw materials from March 1, 2021 onwards.

5 Raw Materials Added to the Health Food Raw Materials Directory
CSAR Launched and New Regulatory Controls on Cosmetics

The NMPA announced various updates regarding soap, toothpaste, hair removal, hair growth, breast beauty, body slimming and deodorizing products.

March 11, 2026
CSAR Launched and New Regulatory Controls on Cosmetics
Public Consultation on Chemical Detection and Efficacy Evaluation Methods in Cosmetics

The NIFDC released 7 technical draft proposals for detecting chemical agents and the evaluation of efficacy claims in cosmetic products in China.

March 11, 2026
Public Consultation on Chemical Detection and Efficacy Evaluation Methods in Cosmetics
Filing Requirements Updated for Non-sterile Ultrasound Couplants

Ultrasonic coupling agents are reminded to comply with mandatory standards and any necessary filing changes must be completed by the end of February 2021.

March 11, 2026
Filing Requirements Updated for Non-sterile Ultrasound Couplants
Draft Regulation for Drug-Device Combination Product Registration in China

The new draft clarifies the registration requirements and categorization method of different drug-device combination products in China.

March 11, 2026
Draft Regulation for Drug-Device Combination Product Registration in China
China Regulatory Round-up for Medical Devices in November and December 2020

3 GB standards announced; 14 technical guidelines and 2 draft guidelines were issued; 6 medical devices pending for fast-track approval

March 11, 2026
China Regulatory Round-up for Medical Devices in November and December 2020
Smart Review Process for Medical Device Registration Coming Soon?

Due to the 2020 performance of the fast-track approval process for medical device registration in China, the CDME plans to implement a smart review process.

March 11, 2026
Smart Review Process for Medical Device Registration Coming Soon?
Technical regulation TSG 23 - 2021 for gas cylinder safety and 1st amendment of TSG 21 - 2016 published

The China SAMR published the new ordinance TSG 23 covering previous regulations such as TSG R1003-2006, TSG R4001-2006, TSG R7002-2009, and TSG R7003-2011.

March 11, 2026
Technical regulation TSG 23 - 2021 for gas cylinder safety and 1st amendment of TSG 21 - 2016 published
Cisema as new partner in the MTC
Cisema as new partner in the MTC

The MTC bundles the potential and expertise of our partners, increasing the innovative strength and international competitiveness of each individual company

March 29, 2022
Cisema as new partner in the MTC
2020 Directory of Health Claims Approved for Health Food Expanded

The SAMR issued the 2020 directory of health food raw materials and nutrient supplements, expanding the number of approved health claims.

2020 Directory of Health Claims Approved for Health Food Expanded
Guidelines for Reporting Adverse Events

The NMPA issued guidelines to address the standard procedure of submitting risk evaluation reports after the occurrence of adverse events.

March 29, 2022
Guidelines for Reporting Adverse Events
AI Regulatory Developments and Planning Issued by China Regulator

The CMDE shared a timeline of events for establishing regulatory control on AI medical devices and shared the latest status of their upcoming plans.

March 29, 2022
AI Regulatory Developments and Planning Issued by China Regulator
Next Big Step for the Introduction of Hong Kong Medical Devices to the Greater Bay Area

The State Administration for Market Regulation addressed the innovative development plan actions for drugs and medical devices in the Greater Bay Area.

Next Big Step for the Introduction of Hong Kong Medical Devices to the Greater Bay Area
China Implements Trial Version of Real-World Data Guidelines

China’s NMPA issues technical guidelines (trial) for utilizing real-world data (RWD) in the medical device clinical evaluation process.

March 29, 2022
China Implements Trial Version of Real-World Data Guidelines
Pilot Plan of the UDI System in Hainan Launched

Following the launch of the China’s national UDI system, the Hainan MPA has announced a pilot plan for the UDI system in Hainan with a larger product scope.

March 11, 2026
Pilot Plan of the UDI System in Hainan Launched
Technical regulation TSG 11 - 2020 for boiler safety published

The new ordinance TSG 11 (Revision 2020) for safety technology for boilers was published with Notice 45/2020 of the authority SAMR.

March 11, 2026
Technical regulation TSG 11 - 2020 for boiler safety published
Various Updates on China's Health Food Regulations

The SAMR issued technical guidelines concerning toxicology, strains used, physicochemical properties and hygienic indicators for health food products

Various Updates on China's Health Food Regulations

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