China Regulatory News

Starting from June 1, 2024, medical devices listed in the third batch implementation product catalogue in China must complete registration and obtain a Unique Device Identification (UDI) in accordance...

Starting from June 1, 2024, medical devices listed in the third batch implementation product catalogue in China must complete registration and obtain a Unique Device Identification (UDI) in accordance with the new regulations, according to the National Medical Products Administration (NMPA) Announcement No. 22 of 2023.

Implementation of the UDI System

The Unique Device Identification (UDI) System Rules, which were established by the NMPA on October 1, 2019, aim to standardise the construction of UDIs and strengthen the lifecycle management of medical devices. Each device receives a unique identification code, and registrants must create, maintain, and assign the UDI for devices, upload data, and use the UDI to improve the overall lifecycle management of devices.

First and Second Batch

On January 1, 2021, NMPA decided to implement the UDI system for the first batch of 69 Class III medical devices, and on June 1, 2022, following the implementation for the second batch of other Class III medical devices (including in vitro diagnostic reagents), Order No. 22 of 2023 announced the third batch of products to adopt the UDI system.

Details of the Third Batch

This third batch includes high-demand single-use products, items selected for centralized procurement, and medical aesthetic products, totaling 103 types in 15 categories. The detailed catalogue can be found on the official announcement page here.

Compliance Requirements

The new regulations took effect on June 1, 2024. From that date, new registration applicants are required to submit product identifiers for the smallest sales unit in the registration system. For devices registered before June 1, 2024, registrants must provide these identifiers when renewing or amending their registrations.

On April 30, 2024, the National Institutes of Food and Drug Control (NIFDC) published two essential guidelines for the identification and assessment techniques of risk substances in cosmetics. These t...

On April 30, 2024, the National Institutes of Food and Drug Control (NIFDC) published two essential guidelines for the identification and assessment techniques of risk substances in cosmetics. These two guidelines are summarized below in two scenarios.

Scenario one

First group

• Special cosmetics, baby & child cosmetics, cosmetics containing new ingredients within the safety monitoring period.

Second group

• Products containing nanomaterials.

• Non-sunscreen cosmetics using sunscreens not listed in the "Cosmetic Safety Technical Specifications".

• Products claiming efficacy in acne treatment, anti-wrinkle (excluding physical anti-wrinkle), deodorizing, dandruff removal, hair removal or exfoliation (excluding physical exfoliation).

• Product forms that include patches, films, containing substrates (patches, films, substrates containing active ingredients or dyes, etc.), or aerosols.

• Products that require the use of instruments or tools (excluding brushes, cushions, hair styling tools used only for auxiliary application, etc.

Scenario two

All other ordinary cosmetics from the second group, but not included in scenario one.

These two guidelines are applicable to registrants and filing applicants to identify and evaluate the possible risk substances in cosmetics.

For more information on compliance with China’s cosmetic regulation, please contact GPC Regulator Executive:  jingyan@cn.gpcregulatory.com or annie@cn.gpcregulatory.com

On 19 April 2024, China’s Centre for Drug Re-evaluation (NMPA) and the National Centre for Adverse Drug Reaction Monitoring issued final guidelines on the collection and reporting of adverse reactio...

On 19 April 2024, China’s Centre for Drug Re-evaluation (NMPA) and the National Centre for Adverse Drug Reaction Monitoring issued final guidelines on the collection and reporting of adverse reactions to cosmetics for registrants and filers.  

The guidelines provide guidance on how to go through each step of the procedure, which includes the following:

• Collection of adverse reactions to cosmetics.

• Recording and communication of adverse reactions to cosmetics.

• Confirmation of cosmetic adverse reaction reports.

• Analysis and evaluation of adverse reactions of cosmetics.

• Submission of Cosmetic Adverse Reaction Reports.

• Quality control of Cosmetic Adverse Reaction Reports

• Cosmetic adverse reaction record management.

Categorization and Reporting Procedures

Reactions are categorized into 3 groups according to how severe they are as follows:

• General cosmetic adverse reactions

• Serious cosmetic adverse reactions

• Cosmetic adverse reactions that may cause greater social impact.

Registrants and recorders must report cosmetic adverse reactions within a specified time frame, starting from the first discovery of the reaction, which is recorded as Day 0. General adverse reactions should be reported within 30 days, serious reactions within 15 days, and reactions with social impact within 3 days.

Record-Keeping and Administration

Monitoring records should as a minimum include reporter information, information about adverse reactions, symptoms or signs, the severity of the adverse reaction, date of occurrence of adverse reactions, date of discovery or knowledge of the adverse reaction, date of reporting of the adverse reaction, name of the cosmetics used, etc.

Records, whether paper or electronic, should be kept properly to prevent loss or damage, be clear, legible, and easy to understand and have  a retention period of at least three years.

On 22 April 2024, the National Medical and Pharmaceutical Administration of China (NMPA) announced an updated Technical Guidelines for Cosmetic Safety Assessment, which will be implemented from 1 May ...

On 22 April 2024, the National Medical and Pharmaceutical Administration of China (NMPA) announced an updated Technical Guidelines for Cosmetic Safety Assessment, which will be implemented from 1 May 2024. This update will further assist companies currently preparing Cosmetic Product Safety Reports (CPSRs) to achieve faster registration.

Details of Rules 2024 nr 50 (updated on 22 April 2024 based on Rules 2021 nr 51):

• The updated technical guideline for cosmetics has published examples of both the detailed and simplified format. This change will further facilitate the process of submitting CPSRs.

• Before 1 May 2025, the legal representative or recordation of the registration can follow the officially published technical guideline to provide the required information for CPSR directly in the simplified format.

• All the registration and recordation shall follow the Safety Evaluation Capacity and Standard proposed by the Cosmetic Safety Evaluation Measures. This Cosmetic Safety Evaluation Measures addresses the importance of the following matters: strengthening technical instruction and providing a safer foundation for the supervision of cosmetic-related products.

For more information on how to comply with China’s cosmetic regulations, please contact GPC regulators  jingyan@cn.gpcregulatory.com or annie@cn.gpcregulatory.com.

On 12 March 2024, the National Health Commission of China (NHC) released a new standard GB 4806.15-2024 for adhesives in materials used for food preparation and storage. This new standard introduces c...

On 12 March 2024, the National Health Commission of China (NHC) released a new standard GB 4806.15-2024 for adhesives in materials used for food preparation and storage. This new standard introduces controls on food contact materials (FCMs) including composite materials and pressure-sensitive adhesives.

Categorization of Adhesive

The standard divides adhesives into two categories: direct and indirect food contact applications. Direct food contact applications which have a higher migration risk will be more strictly regulated. For indirect food contact applications which have lower migration risks, the requirements will be less stringent.

Requirements and Implementation

The new standard also includes a list of substances that can be used for direct and indirect food contact and the requirements for their use in the annexes. According to the annexes, 51 raw materials are approved for direct food contacts and 341 substances are permitted for indirect food contact materials. Materials approved for direct contact applications are also approved for indirect contact materials.

Adhesive products must indicate on the label which category they fall into. Additionally, additives used in adhesives must meet the requirements of standards GB 4806.1-2016, GB 9685-2019, and any further announcements.

Implementation Date and Contact Information

The new standard will come into force on 8 February 2025. For further information, please contact Global Product Compliance (GPC) at compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com.

On 12th March 2024, The Ministry of Industry and Information Technology of China (MIIT) published a notification soliciting public comments on the draft standard of GB 30000.1: Rules for classificati...

On 12^th March 2024, The Ministry of Industry and Information Technology of China (MIIT) published a notification soliciting public comments on the draft standard of GB 30000.1: Rules for classification and labelling of chemicals—Part 1 General specifications. According to the notification, once the new standard is approved, it will be effective 12 months after the publication and the previous standards GB 13690-2009 will be appealed. 

Basis for technical requirements in GB 30000.1 

The technical content of this standard is mainly derived from the GHS system. This standard specifies the terms and definitions involved in the classification and labeling of chemicals, categories of hazardous properties of chemicals, classification standards for substances and mixtures, guidance on the preparation of chemical safety labels, and guidance on the preparation of chemical safety data sheets (SDS). regulations etc.

The main content of this standard consists of the following parts: 

1. Terms and definitions 
2. Chemical hazard classification
3. Label 
4. Chemical Safety Data Sheet

Main changes to GB 13690-2009

Firstly, the name of this standard is changed to Rules for classification and labelling of chemicals—Part 1:General specifications. 

Secondly, it added "United Nations Globally Harmonized System of Classification and Labeling of Chemicals (Eighth Revised Edition)" and "United Nations Model Regulations on the Recommendation on the Transport of Dangerous Goods (Twenty-second Revised Edition)" as cited documents, deleted Referenced documents "GB/T 22272~ GB/T 22278". 

Thirdly, it adjusted the regulations on chemical hazard classification: 4.1.1 Hazard Category a) Added desensitizing explosives to physical hazards. 

Fourthly, it deleted sample sheets in the appendix: 

1. Deleted Informative Appendix A "Examples of Precautionary Statements", while added Informative Appendix A "Definitions and Abbreviations Specified in GHS". 
2. Deleted Informative Appendix B "Pictograms of Protective Measures". 
3. Deleted Informative Appendix C "Sample GHS Label"; 
4. Deleted informative Appendix D "Minimum Information on Safety Data Sheets". 

For more information regarding China GHS and China REACH related inquires, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

The Solid Waste and Chemicals Management Center (SCC) under the Ministry of Ecology and Environment of China (MEE) published a notification to remind new chemical substance registrants to submit 2023 ...

The Solid Waste and Chemicals Management Center (SCC) under the Ministry of Ecology and Environment of China (MEE) published a notification to remind new chemical substance registrants to submit 2023 annual reports before 30th April via the online registration system. 

According to MEE Order No.12, the following types of new chemical substance registration have annual report obligation. 

• Certificates obtained under MEP Order No.7, and the new substance belongs to key environmental management categories; and 
• Certificates obtained under MEE Order No.12, and the annual report obligation was specified in the regular registration certificate. 

As required, registrants shall include the following information in the annual report.  

• Actual production in 2023.
• Import volume of chemical in 2023.
• Environmental release details, the implementation status of environmental risk control measures.
• Environmental management requirements.

The registrants or their agents in China shall log into the system and fill in the report form online. SCC also disclosed a list of registrants subject to annual report obligation. If you are not sure if you have annual report obligation, please submit a query to GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com, we will help to you to check.