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First Hong Kong Medical Device Approved for Clinical Use in the Greater Bay Area

The Guangdong MPA announced the first approved medical device arriving the University of Hong Kong – Shenzhen Hospital via the Greater Bay Area initiative.

March 29, 2022
First Hong Kong Medical Device Approved for Clinical Use in the Greater Bay Area
New Regulatory Updates Concerning Health Food Filing

The SAMR published new technical requirements to expand the scope of health food in dosage forms and excipients for filing, with effect from June 1 onwards.

New Regulatory Updates Concerning Health Food Filing
New Regulatory Controls to Support the CSAR Including Animal Testing Exemptions

The NMPA announced 2 new Provisions to support the implementation of the CSAR, and the exemption of animal testing for general cosmetics.

March 29, 2022
New Regulatory Controls to Support the CSAR Including Animal Testing Exemptions
NMPA Amends Safety and Technical Standards for Cosmetics

On March 2, 2021, the NMPA announced 7 major updates on the Safety and Technical Standards for Cosmetics (2015 version) with effect from May 1 onwards.

March 29, 2022
NMPA Amends Safety and Technical Standards for Cosmetics
China Regulatory Round-up for Medical Devices in March 2021

22 technical guidelines (draft) were issued in March 2021, and technical guidelines for products monitoring non-invasive blood / glucose will be drafted

March 29, 2022
China Regulatory Round-up for Medical Devices in March 2021
Update of Administrative Measures for the Clinical Use of Medical Devices

The NHC announced the implementation of The Administrative Measures for the Clinical Use of Medical Devices coming into force from March 1, 2021 onwards.

March 29, 2022
Update of Administrative Measures for the Clinical Use of Medical Devices
Guangdong's Pilot Plan for Hong Kong Medical Devices to enter the China Greater Bay Area

The Guangdong MPA (Medical Products Administration) announced details about the pilot plan and the responsibilities of different departments involved.

March 29, 2022
Guangdong's Pilot Plan for Hong Kong Medical Devices to enter the China Greater Bay Area
NMPA Introduces the Medical Device Master Filing System

The NMPA announced the implementation of a mNMPA Introduces the Medical Device Master Filing System covering both medical devices and IVDs.

March 13, 2026
NMPA Introduces the Medical Device Master Filing System
Positive development for remote inspections to obtain SELO China manufacturer license

First remote inspection successfully carried out in January 2021 for SELO China manufacturer license, and many more to come.

March 11, 2026
Positive development for remote inspections to obtain SELO China manufacturer license
Updates on the Medical Device Classification Catalogue in China

The NMPA announced a total of 28 updates on the classification catalogue for medical devices including 15 classification changes and 13 content updates.

March 29, 2022
Updates on the Medical Device Classification Catalogue in China
Cisema Partners with Advamed
Cisema Partners with Advamed

AdvaMed advocates globally for the highest ethical standards and patient access to safe, effective and innovative medical technologies that improve lives.

March 29, 2022
Cisema Partners with Advamed
Guidelines for Sampling Testing on Organic Foods

On December 4, 2020, the CNCA announced the temporary guidelines for sampling testing on five groups of organic food products in China.

Guidelines for Sampling Testing on Organic Foods
Draft of Prohibited List and Existing List of Cosmetic Ingredients Announced

2 amendment drafts concerning the prohibited list of cosmetic ingredients & the IECIC (Inventory of Existing Cosmetic Ingredients in China) were released.

March 29, 2022
Draft of Prohibited List and Existing List of Cosmetic Ingredients Announced
Guideline and Standard Update for Medical Devices & IVDs in January and February 2021

6 technical guidelines & 4 GB / YY draft standards were announced; 2 products registered & 7 applications accepted by the fast-track approval pathway.

March 13, 2026
Guideline and Standard Update for Medical Devices & IVDs in January and February 2021
NMPA 2020 Annual Report on Medical Device Mandatory Standards

On February 5, the NMPA issued a report covering a breakdown of the total existing and new standards for medical devices in 2020.

March 29, 2022
NMPA 2020 Annual Report on Medical Device Mandatory Standards
Updates on the Clinical Trial Exemption List for Medical Devices and IVDs

On January 19, the NMPA announced the new clinical trial exemption list for medical devices and in-vitro diagnostics reagents.

March 13, 2026
Updates on the Clinical Trial Exemption List for Medical Devices and IVDs
NMPA 2020 Annual Report of Medical Device & IVD Registrations in China

A total number of 10579 applications and 9849 approvals for medical device registrations in China were reported in 2020 along with a detailed breakdown.

March 13, 2026
NMPA 2020 Annual Report of Medical Device & IVD Registrations in China
Administrative Measure on Cosmetics Registration and Filing

The SAMR addressed the basic requirements for registration and filing management of cosmetics and new cosmetic ingredients in China to begin on May 1, 2021.

March 11, 2026
Administrative Measure on Cosmetics Registration and Filing
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

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