
CIRS Testing provides a complete medical device chemical testing service, built around the chemical-substance requirements of the EU MDR, REACH, RoHS, the POPs Regulation, China NMPA/GB, and US FDA / ISO 10993 frameworks.

CIRS Testing provides a complete medical device chemical testing service, built around the chemical-substance requirements of the EU MDR, REACH, RoHS, the POPs Regulation, China NMPA/GB, and US FDA / ISO 10993 frameworks.

Per- and Polyfluoroalkyl Substances (PFAS), commonly known as "forever chemicals", feature extremely stable carbon-fluorine bonds, high bioaccumulation potential and suspected endocrine disrupting properties, leading to stringent regulatory restrictions worldwide. According to OECD statistics, the PFAS family comprises over 10,000 substances. Fluoropolymers including Polytetrafluoroethylene (PTFE), FEP, PFA, PVDF and PCTFE are widely applied in cardiovascular catheters, implant coatings, pacemaker wire insulation, as well as sterile high-barrier packaging for medical devices.

Recently, Haier Group announced the bidding results, and CIRS Testing has been fully recognized, once again becoming Haier Group's hazardous substance testing service provider. CIRS Testing will continue to offer high-quality inspection, regulatory assessment, and sustainable development projects as part of a one-stop compliance solution for Haier and its supply chain enterprises.

On November 3, 2025, China's Ministry of Industry and Information Technology (MIIT) released a notice soliciting public comments on the draft Catalog for Compliance Management of the Restriction of Hazardous Substances in Electrical and Electronic Products (2025 Edition) and the draft List of Applications Exempted from Restricted Substances in the Compliance Management Catalog (2025 Edition). The public consultation period lasts until December 2, 2025.

Recently, the State Administration for Market Regulation (Standardization Administration of China) issued the 23rd announcement of 2024, approving the release of 20 new mandatory national standards and one amendment to an existing mandatory standard. Among them is the mandatory national standard for the watch industry, GB 44702-2024 "Regulations on the Limit of Harmful Substances in Watch Components in Direct Contact with Human Skin," which will be implemented starting October 1, 2025. All relevant units need to pay close attention to the content of the new standard to ensure that their products comply with the national requirements.

On June 29, 2024, the State Administration for Market Regulation (Standardization Administration of the People's Republic of China) issued the "Announcement on the Approval and Release of 109 National Standards and 4 National Standard Amendments" (National Standard Announcement [2024] No. 14), hereinafter referred to as the "Announcement". The content of the Announcement includes: No.1 amendment to GB/T 26572-2011 "Requirements of Concentration Limits for Certain Restricted Substances in Electrical and Electronic Products", which is a supporting measure for China RoHS. The amendment includes the addition of restrictions on phthalate substances. This amendment will officially come into effect on January 1, 2026.

Perfluorohexane sulfonic acid (PFHxS) is a highly surface-active perfluorinated compound with chemical properties similar to perfluorooctane sulfonic acid (PFOS). Following the ban on PFOS by the Stockholm Convention in 2009, PFHxS has been widely used as a substitute in various products. However, PFHxS is persistent in the environment, capable of long-range transport, and may cause developmental toxicity, neurotoxicity, hepatotoxicity, and reproductive toxicity. At the 10th Conference of the Parties to the Stockholm Convention (SC COP-10), PFHxS, its salts, and related compounds were listed in Annex A of the Convention for elimination, with no exemptions allowed.

On January 25, 2024, China‘s Ministry of Industry and Information Technology, the Ministry of Commerce, and the General Administration of Customs jointly issued a notice on simplifying the import and export control over mixtures containing low concentrations of triethanolamine, which will take effect on February 1, 2024. According to the notice, products with low concentrations of triethanolamine, including non-medical disinfectants, synthetic detergents, cosmetics, and inks, are no longer subject to the import & export control for triethanolamine (HS code: 2922150000), and triethanolamine mixtures (HS code: 3824999950) listed in the Catalogue of license for dual-use items and technologies.

Dechlorane Plus (DP) is an additive flame retardant widely used in polymer materials such as plastics and fibers due to its excellent colorability, thermal stability, outstanding electrical properties, and low smoke emission. However, as significant risks of exposure to humans and the environment associated with DP have been confirmed, various regions globally have initiated actions to control this substance. Many export-oriented electronic product companies have already started supply chain investigations regarding this substance.

Hangzhou CIRS C&K Testing Technology Co., Ltd. officially inaugurated its new toxicology laboratory in August. Located in the Tianhe High-tech Industrial Park in the Binjiang District of Hangzhou, Zhejiang Province, this lab is to provide toxicological tests and research services to industries such as cosmetics, medical devices, health products, specialty foods, and pharmaceuticals.