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The National Certification and Accreditation Administration (CNCA) recently announced changes to the national standards for wire assemblies, which will take effect on 1 October 2025. The new version of the standard, GB/T 15934-2024, revises and integrates the two previous national standards, GB/T 15934-2008 and GB/T 26219-2010. This update ensures consistency and better regulatory oversight for electrical accessories and interconnection wire assemblies, which are crucial in various industries, including medical devices and MedTech.
Key Updates to the Certification Standards
1. The new GB/T 15934-2024 standard replaces GB/T 15934-2008 and GB/T26219-2010, consolidating requirements for wire assemblies.
2. The certification standard for wire assemblies under the Implementation Rules for Compulsory Product Certification (CNCA-C02-01:2014) will now follow GB/T 15934-2024.
3. The scope of compulsory product certification remains unchanged.
4. Certification bodies must implement compliance with the revised standard as per Announcement No. 4 of 2012 by the CNCA.
Implications for the MedTech and Healthcare Industry
Wire assemblies are critical components in medical devices, powering life-saving equipment such as ventilators, patient monitoring systems, imaging devices (MRI, CT scanners), and surgical robots. The updated national standard ensures greater reliability, safety, and quality in electrical connections, directly impacting patient safety and device performance.
1. Enhanced Safety and Reliability
The integration of older standards into a single framework enhances regulatory compliance and streamlines the certification process for medical device manufacturers. This ensures that wire assemblies used in MedTech applications meet stringent safety requirements, reducing the risk of malfunctions or electrical failure.
2. Compliance for Medical Device Manufacturers
Medical device companies operating in China or exporting to the Chinese market must align their electrical accessory and interconnection wire assemblies with the new standard. This compliance is essential for obtaining the necessary certifications to market medical technologies within China.
3. Impact on Medical Device Design and Production
With stricter guidelines in place, manufacturers must evaluate their current supply chains, quality control processes, and product designs to ensure they meet the revised standards. Failure to comply could lead to delays in certification, affecting market entry and business operations.
4. Strengthening MedTech Regulatory Frameworks
The revision aligns with global trends in medical device standardization, similar to ISO and IEC standards, promoting international harmonization in electrical safety regulations. This benefits companies aiming for global compliance in multiple markets.
Preparing for Compliance
Healthcare and MedTech companies should take proactive steps, including:
Reviewing the new GB/T 15934-2024 standard requirements
Engaging with certification bodies early to ensure compliance
Updating technical documentation and testing protocols accordingly
Ensuring suppliers of wire assemblies adhere to the new guidelines
As the deadline of 1 October 2025, approaches, staying informed and preparing for the transition will be crucial to ensuring continued compliance and operational efficiency.
For further information and assistance, please contact us at info@arqon.com
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