Global Market Access Regulatory Newsletter – Q3 2025

Vietnam Law on Digital Technology Industry (DTI)

On June 14, 2025, the National Assembly of Vietnam passed the Law on Digital Technology Industry (DTI), which takes effect on Jan. 1, 2026.

This legislation establishes a comprehensive legal framework for the digital technology sector, covering activities, products and services. It aims to support and regulate the industry's growth while defining the rights and responsibilities of individuals and organizations involved.

Focus on artificial intelligence

Chapter IV of the law is dedicated to artificial intelligence (AI) and outlines several key provisions:

1. The law emphasizes the classification and management of high-risk and high-impact AI systems, rather than listing specific prohibitions.  
2. A high-risk AI system is defined as one that could cause harm unless used in narrowly scoped tasks, to optimize work or to verify human decisions without replacing them.  
3. A high-impact AI system refers to a multi-purpose AI system with a large user base, extensive parameters and significant data volume.  

Both categories are subject to strict management requirements, including:

AI systems that interact directly with humans must notify users that they are engaging with an AI system, unless it is obvious to the user that the interaction involves AI.

Oversight and responsibilities

The Ministry of Science and Technology (MoST) will establish a list of AI-generated products, which will serve as the basis for a required identification mark. The law also clearly defines the roles and responsibilities of AI system developers, providers and users. Additionally, the law encourages research, development and application of AI technologies as a national priority.

No conformity assessment requirement  

It is important to note that the law does not specify any conformity assessment requirements for AI systems at this time.

https://vanban.chinhphu.vn/?pageid=27160&docid=214609&classid=1&typegroupid=3

MPCA Delays PFAS-Containing Products Reporting

The state of Minnesota is one of the first U.S. states to enact legislation aimed at reducing pollution from per- and polyfluoroalkyl substances (PFAS), with the goal of eliminating avoidable use by 2032.

Minnesota’s PFAS legislation, commonly referred to as Amara’s Law (Minnesota Statutes § 116.943), establishes a phased approach to prohibit the sale of products containing intentionally added PFAS. These prohibitions apply unless the use of the PFAS in a product is determined to be a currently unavoidable use (CUU) or the product is specifically exempted. The law also includes mandatory reporting requirements and associated fees to help the Minnesota Pollution Control Agency (MPCA) collect data on products containing intentionally added PFAS.

Initially, manufacturers were required to begin reporting on Jan. 1, 2026. However, on July 23, 2025, the MPCA announced a six-month extension of the initial reporting deadline. 

The new deadline is July 1, 2026, allowing manufacturers additional time to:  

• Negotiate agreements with suppliers to report on their behalf
• Gain proficiency with a new reporting platform and utilize tools designed to streamline the reporting process.

Under Amara’s Law, any manufacturer of a product sold, offered for sale or distributed in the state that contains intentionally added PFAS must submit the following information to the MPCA through the upcoming PFAS Reporting and Information System of Minnesota (PRISM):

The PRISM platform is expected to launch in Fall 2025, while rulemaking to finalize the reporting requirements is still underway and anticipated to be completed by early 2026. 

https://www.pca.state.mn.us/air-water-land-climate/reporting-pfas-in-products

Bangladesh - MOI Adds 16 New Mandatory Products

On June 3, 2025, the Ministry of Industries (MOI) published S.R.O. No. 263-Act/2025 and S.R.O. No. 264-Act/2025, adding 16 new products to the list of items requiring mandatory certification by the Bangladesh Standards and Testing Institution (BSTI). These include household electric hobs, dishwashers, washing machines, kitchen machines, kitchen hoods and other cooking fume extractors.  

• S.R.O. No. 263-Act/2025 mandates that products conforming to the relevant Bangladesh standards must bear the Bangladesh Standard Mark, either on the packaging or label, where applicable.  
• S.R.O. No. 264-Act/2025 prohibits the sale, distribution and commercial advertisement of the products specified in Column (2) unless they comply with the Bangladesh Standard specified in Column (3). 

With this update, the total number of products under BSTI’s mandatory certification scheme now stands at 315.

This notification will take effect two months after its publication in the Official Gazette.

https://www.dpp.gov.bd/upload_file/gazettes/57778_76093.pdf

https://www.dpp.gov.bd/upload_file/gazettes/57779_69001.pdf

China Enhances Electric Bicycle Compliance

On June 24, 2025, the Ministry of Industry and Information Technology (MIIT), along with three other departments, issued Joint Announcement No. 144 of 2025, titled “Opinions on Strengthening the Implementation of Mandatory National Standards for Electric Bicycles and Accelerating the Supply of New Products.” This directive outlines enforcement measures for the new mandatory national standard GB 17761-2024 and management policies for electric bicycles in the Chinese market.

The new standard: GB 17761-2024, Safety Technical Specification for Electric Bicycles, was published on Dec. 31, 2024, implemented Sept. 1, 2025, and replaces GB 17761-2018.  

Key measures:

Production oversight

• Manufacturers must cease development of products under the old standard.
• Enterprises are encouraged to upgrade production lines.
• Leading companies are expected to set industry benchmarks.
• The government will support companies in resolving operational challenges during the transition.

Certification enforcement

• Certification bodies must strictly follow the new standard and China Compulsory Certification (CCC) rules.
• Non-compliant products will have certifications revoked.  
• Requests for outdated product certifications are to be discouraged.

Sales regulation

• Products made or imported on or before Aug. 31, 2025, under the old standard may be sold until Nov. 30, 2025.
• Authorities will crack down on illegal sales, unauthorized modifications and counterfeit components.
• Online platforms must not list non-compliant or modified electric bicycles.

Registration control

• Public security agencies must verify invoices, product certificates, CCC certification and other certificates and credentials.
• License plates will only be issued to compliant electric bicycles, not electric motorcycles or mopeds.
• Products sold on or before Aug. 31, 2025, under the old standard may apply for registration until Nov. 30, 2025.

Replacement and recycling

• Subsidies and trade-in programs will be expanded.
• Priority will be given to replacing old lithium batteries and promoting compliant models in logistics and public sectors.  

Consumer protection

• Consumer channels for violation and non-compliant or uncertified electric bicycle reporting will be provided through hotlines and online platforms.  
• Authorities will work together to investigate complaints quickly and protect consumer rights.  
• Regulators will strengthen recall processes for defective products and see that manufacturers take responsibility.

Long-term supervision

• Jointly promote the implementation and supervision of national standards for electric bicycles and the supply of new products.
• Strengthen the investigation of fire and fatal accident cases and trace causes and hold responsible parties accountable.
• Provide widespread education on safety and risk awareness.
• Industry associations are urged to promote self-regulation, improve product quality and offer safer electric bicycles to consumers.

https://www.miit.gov.cn/zwgk/zcwj/wjfb/yj/art/2025/art_ba4387a19a534f419c0fdd7070726e0a.html

China Updates CCC Rules for Batteries and Power Packs

On Aug. 1, 2025, the National Certification and Accreditation Administration (CNCA) announced new certification implementation rules for China Compulsory Certification (CCC) covering:

Product category 0914 – Mobile power supplies or power banks  

Product category 0915 – Lithium-ion cells and battery packs

Key regulatory updates

CNCA implementation rules

• New rule – CNCA-C09-02:2025 (Trial)
• Issued – July 28, 2025
• Effective – Aug. 15, 2025
• Replaces – CNCA-C09-01:2023

Certified products must meet all applicable standards, such as GB 4943.1 for audio/video and information and communication technology (ICT) equipment safety and GB 31241 for the safety of lithium-ion batteries used in portable electronics.

Existing valid CCC certificates remain usable and will transition naturally through renewals, modifications for product changes or standard upgrades.

CQC implementation rules

Following CNCA’s announcement, the China Quality Certification Centre (CQC) released its own updated rules:

• New rule – CQC-C0902-2025 (Trial)
• Issued – Aug. 7, 2025
• Effective – Aug. 15, 2025
• Replaces – CQC-C0901-2023  

Key updates to the CQC rules:

I. Certification model adjustments:

• Type testing
• Initial factory inspection
• Post-certification supervision

II. Manufacturing oversight:

• Clear requirements for key production processes
• Revised classification principles for manufacturers
• Original equipment manufacturer (OEM) and original design manufacturer (ODM) derivative requirements updated

III. Testing protocols:

• Samples must be collected directly from production sites
• Real-time video recording of sampling/testing required
• Labs must store tested samples for future reference
• Manufacturer self-testing is no longer permitted

IV. Post-certification supervision

• Frequency and scope adjusted
• On-site sampling and testing added
• Updated list of key components and materials

Transition guidance

From Aug. 15, 2025, all CCC applications for power banks and lithium-ion batteries must follow the new CQC-C0902-2025 rule. Existing certificates under the old rule remain valid and will transition naturally through renewals, modifications or standard upgrades.

https://www.cnca.gov.cn/zwxx/gg/2025/art/2025/art_915c12eceb7a4ad1a848e9598844e911.html

https://www.cqc.com.cn/www/chinese/c/2025-08-12/599144.shtml

Canada Aligns Laser Rules with IEC Standards

On Oct. 9, 2024, Health Canada published updated Radiation Emitting Device Regulations (REDR) pertaining to laser products. These new regulations will take effect one year after publication. The rules align closely with IEC 60825-1:2014 (safety of laser products: part 1 — equipment classification and requirements) for classification, engineering features, labeling and user information.  

In certain cases, requirements from IEC 62471:2006 (photobiological safety of lamps and lamp systems) and IEC 62471-5:2015 (photobiological safety of lamps and lamp systems — part 5: image projectors) may also be accepted.  

Reasons behind the update

Global alignment

IEC 60825-1 is widely recognized as the international benchmark for laser safety*

Improved labeling

Clear classification labeling helps users better understand potential laser radiation hazards.

*The U.S. is a notable exception, where the primary safety regulation for laser products is Title 21 of the Code of Federal Regulations (CFR), Chapter I, Subchapter J, Parts 1000 through 1040 (21 CFR Parts 1000 – 1040), enforced by the U.S. Food and Drug Administration (FDA) (FDA/CDRH 21 CFR 1040). While U.S. FDA Laser Notice 56 offers an optional pathway for alignment with IEC standards, it does not replace the core requirements of 21 CFR 1040. 

Expanded scope

Previously, REDR primarily focused on laser scanners and demonstration lasers. The new regulations expand this scope to cover all laser products except:  

• Medical devices as defined in the Canadian Medical Devices Regulations (CMDR)  
• Components and repair parts, under specific conditions  

User information requirements

To be subject to the new regulations, user information must comply with:  

• IEC 60825-1:2014 subclause 8.1  
• IEC 62471-5:2015 subclauses 6.6 and 6.7, where applicable

A key distinction: While IEC 60825-1 applies broadly, Health Canada’s REDR user information requirements specifically apply to Class 3R or higher laser radiation that may be accessible during operation, maintenance or service.  

Additionally, the REDR exempts manufacturers from IEC 60825-1's requirements for purchase and service information. 

New Canada Laser Regulations | UL Solutions

Notice: New requirements for laser products - Canada.ca