STC’s Medical Device Laboratory has officially been approved and accredited as a GLP testing laboratory by the Mexican GLP Regulatory Agency ema-Mexican Accreditation Body, a member of the Organization for Economic Co-operation and Development (OECD). Ema has conducted a comprehensive review of STC’s medical device laboratories, including organizational structure, personnel, SOP, test products, archives management, experimental facilities and equipment, test implementation process, quality assurance system, etc., and made a comprehensive retrospective inspection on a number of randomly selected studies that complied with OECD GLP specifications.
After careful and detailed auditing, the auditors concluded that the GLP system of STC’s Medical Device Laboratory is fully compatible with the requirements of OECD's GLP principles. The standardized experimental institution management, perfect and effective quality assurance system, reliable facilities and equipment, and standardized and complete experimental records have been highly recognized by the auditors, who believe that STC’s Medical Device Laboratory has a good understanding of OECD's GLP principles and has established a quality management system that is both suitable for itself and in line with international standards.At the same time, the inspection team has also given some good suggestions, to help STC’s Medical Device Laboratory to further improve the existing GLP system and enhance its international service capabilities.
Recently, STC’s Medical Device Laboratory has also obtained the China laboratory animal use permit for large animal studies, which covers all animal models for biological testing of medical devices. Then STC smoothly passed the latest ISO 17025 revision review and CNAS expansion review. Large animal studies, oral mucosal irritation, brain implantation, and other studies were also successfully recommended and approved. Next, STC will make continuous efforts to improve its quality management level and technical ability in order that we can provide a reliable and fast service platform for the global registration of medical devices, support and promote innovation of medical devices as well as contribute to human health.
As a member of the STC Group, STC (Dongguan) is an independent, third-party product testing, inspection and certification body approved by the General Administration of Customs of the People’s Republic of China (GACC). In 2012, STC became the first designated testing laboratory in Hong Kong to provide CCC testing services to local manufacturers and importers. In 2014, STC (Dongguan) became one of the first few non-governmental laboratories in China authorized to undertake CCC testing. In 2015, STC invested in a new animal laboratory in Dongguan and began to provide a full range of biocompatibility testing services for medical device manufacturers at home and abroad. STC has successfully obtained the OECD GLP accreditation in early 2019. Over the years, STC has got worldwide accreditation including China Metrology Accreditation (CMA), China National Accreditation Service for Conformity Assessment (CNAS), US Federal Communications Commission (FCC), US Consumer Product Safety Commission (CPSC), Govmark Testing Services, Industry Canada, LUCIDEON, SATRA Technology Centre, DAkkS, Nemko, and CPSA, as well as being a CB Testing Laboratory (CBTL) under the IECEE-CB Scheme, earning it a leading position in the testing, inspection and certification industry of southern China.
About STC(Dongguan) Company Limited
Since its establishment in 2005, STC (Dongguan) Company Limited has been serving the industries and supporting the economic growth with our one-stop conformity assessment services in accordance with local and international product safety standards and regulations. The headquarters, STC (Hong Kong Standards and Testing Centre) was established in 1963 as the first not-for-profit testing, certification and inspection organization in the region. In order to meet the global demand for testing and certification services, not only has STC set up testing facilities and customer service offices in China’s major cities such as Dongguan, Shenzhen, Zhongshan, Shanghai, Changzhou and Haerbin, but also in countries like Germany, Italy, USA, Vietnam and Japan. For more information on STC (Dongguan), please visit www.stc.group
Tel: +86 769 8111 9888 (ext.8633)
Tel: +86 769 8111 9888 (ext.8288)
Tel: +86 769 8111 9888 (ext.8188)