【China, 28 July 2021】To facilitate the transition to the new standard GB9706.1-2020 for manufacturers, Association of Medical Devices Industry in Dongguan City collaborated with the Dongguan laboratory of STC, STC (Dongguan) Company Limited, to jointly hold a seminar to explain the GB9706.1-2020 standard on 28 July 2021 afternoon in Dongcheng, Dongguan.  Ms. Yena Zhuang, Senior Manager of the Medical Devices Department of STC (Dongguan), was invited to be a speaker of the seminar who introduced differences between the old and new standards.  The new standard emphasizes on the importance of risk management and imposes more stringent technological requirements on the safety, protection and basic performance of medical devices.

As a fundamental and key standard for active medical devices, GB9706.1 requires all medical electrical equipment to fully comply with the standard.  Published on 9 April 2020, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance of GB9706.1-2020 will be effective from 1 May 2023.

Established in 2005 and invested by STC, STC (Dongguan) is approved by the General Administration of Customs of the People’s Republic of China (GACC) in its establishment as an independent third-party organization in the field of product testing, inspection and certification.  Over all these years, STC has been keeping abreast of industrial and trade development in the expansion of our global service network.  We are striving to provide the industries with professional, reliable and comprehensive inspection and testing services through the provision of objective, fair and scientific testing reports, with an aim to safeguard consumers’ safety by ensuring technological and safety compliance of products with relevant standards.

About STC

Established in 1963 as an independent, not-for-profit organization over testing, inspection and certification, STC (Hong Kong Standards and Testing Centre) offers a wide range of testing services, including Toys, Children’s Products, Textiles, Apparel, Footwear, Furniture, Electrical and Electronic Products, Medical Devices, Food, as well as Chemical and Pharmaceutical Products.  In 2012, STC became the first designated China Compulsory Certification (CCC) testing laboratory in Hong Kong, providing CCC testing services for manufacturers and importers from China and Hong Kong.  In 2014, STC (Dongguan) became one of the first designated CCC testing laboratories in China with foreign capital.  In 2015, STC (Dongguan) invested in building new laboratories for experimental animals, offering a full range of biocompatibility testing for medical devices manufacturers from China and the world.  It also obtained the accreditation from OECD GLP in 2019.  In 2020, the Hong Kong Certification Centre (HKCC), an independent products certification body under STC, was officially accepted by the International Electrotechnical Commission System of Conformity Assessment Schemes for Electrotechnical Equipment and Components and Certification Body (IECEE CB) as the National Certification Body (NCB) of China in Hong Kong.  This enables STC to issue both CB Test Reports and Certificates, offering one-stop CB certification services.  Over the years, STC has obtained numerous accreditations from international bodies, including CMA (China), CNAS (China), FCC (USA), CPSC (USA), Govmark (USA), IC (Canada), Lucideon (UK), SATRA (UK), Nemko (Norway) and CPSA (Japan), while being a Certification Body Testing Laboratory (CBTL) in IECEE-CB.  With these qualifications, STC has been established as a leading organization in the testing and certification industry.  To meet growing global demand, not only has STC set up cutting-edge testing laboratories and offices in China’s major cities such as Dongguan, Shanghai, Changzhou, Guangxi and Heilongjiang, but it also expanded to Vietnam, Japan, USA and Germany with testing laboratories and offices set up.  Meanwhile, STC is actively developing its business scale to serve as “Your Global Testing, Inspection and Certification Partner” for clients from all walks of life.

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Media Contact:

Kevin Wang                         

Tel: +86 769 8111 9888 (ext.8633)                

Email: kevinwang@stc.group

Business Cooperation:

Yena Zhuang                        

Tel: +86 769 8111 9888 (ext.8187)                 

Email: yenazhuang@stc.group