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)
2019 China Innovation Food Conference & Guangdong-Hong Kong-Macao Greater Bay Area Food Innovation Brand Expo
STC invites you to visit our booth at F371 to check out the latest food safety requirements and testing standards.
Date: July 17-19, 2019
Venue: Guangdong Modern International Exhibition Center (Dongguan)
STC and the Macau Productivity and Technology Transfer Center have jointly launched a professional and independent certification program to enable certified Macau company to obtain the Macau Product Quality Certification Scheme and "STC tested" Mark (Macau), aims to provide an unambiguous definition of product quality for Macau products and strengthen consumers confidence.
STC is now at The 11th Food & Household Products Expo 2019.
Date: 28-30 June 2019
Venue: The Venetian Macau Hall A, Booth No: H3
Come & check out the latest information of "STC tested" mark(Macau).
The Hong Kong Standards and Testing Centre (STC) has always provided testing, inspection and certification services to help the industry monitor and improve the quality, safety and image of products.
In line with the blueprint for development of Guangdong-Hong Kong-Macau Greater Bay Area, “STC tested” Mark (Macau) certification program was born in June 2019. At the same time, the Macau Productivity and Technology Transfer Center has also formally added “STC tested” Mark (Macau) certification program to the optional technical review program of the Macau Product Quality Certification Scheme.
In order to cope with the development of Macau’s industry, if the applicant holds the “Industrial License” of the Macau SAR Government that is the current Macau production enterprise, it is possible to apply the certification program through the Macau Productivity and Technology Transfer Center. For the eligible applicant, the first and the second product lines of application are fully funded by the Macau government for product testing and factory inspection, with the maximum limit MOP80, 000. The first phase was start from food companies.
The Hong Kong Standard and Testing Center (STC) Ms. Anne Chuah, Director of Greater China Operation, and Dr. Lee, General Manager, were invited to attend the seminar of the Macau Product Quality Certification and “STC tested” mark (Macau) which jointly organized by the Industrial Association of Macau and Macau Productivity and Technology Transfer Center.
Ms. Vivian Lam, Product Certification Manager, introduced the relevant application procedures to the production enterprises in Macau during the seminar.
Please find the link below for more details:
STC is now at International Tokyo Toy Show 2019.
Date: 13-14 June, 2019
Venue: Tokyo Big Sight West Halls, 3-11-1, Ariake, Koto-ku, Tokyo, Japan Booth No: 1-24 (Hall 1)
Come & check out the latest toy safety requirements!
STC Chairman Tom Tang and Commissioner of Innovation and Technology Annie Choi Join Celebrity Guest Sammy Leung to Promote Product Safety
STC (Hong Kong Standards and Testing Centre), the first not-for-profit testing, inspection and certification organization established in Hong Kong, held the latest annual Product Safety Carnival cum Certificate Award Ceremony today at Domain Mall in Yau Tong. This year’s Ceremony was officiated by Commissioner of Innovation and Technology, Annie Choi, who delivered a speech to encourage the notable enterprises receiving the Hong Kong Safety Mark, "STC tested" Mark, Hong Kong ECO Mark, and Hong Kong Excellent Service Mark certificates.
Chairman of STC, Tom Tang, JP, announced the appointment of popular entertainer Sammy Leung as this year's Product Safety Ambassador. In addition to sharing tips of being a smart consumer, Leung effortlessly brought cheers to the guests and audiences with his captivating performance of a couple of classic numbers.
Aside from awarding certificates, the Ceremony was the highlight of a 3-day event that brought businesses and consumers together with sales booths offering certified products. In a bid to make product safety education more enjoyable, the event also featured a free 3D photo booth offering a variety of funny props, in addition to a game booth manned by the Electrical and Mechanical Services Department (EMSD).
With a history of more than 50 years, STC, as a not-for-profit, independent testing and inspection organization, spares no effort in promotingthe importance of product safety to different levels of the community and enhancing the development of the testing and inspection industry. Over the years, STC has been upholding the safety standards of food and household products by launching various product certification programmes in line with the latest safety standards such as Hong Kong Safety Mark and “STC tested” Mark. STC has expanded its certification servicesby launching the Hong Kong Excellent Service Certificate Mark,which helps citizens to identify customer-friendly merchants; STC’s Hong Kong ECO Mark and Made in Hong Kong Certification Scheme also aim at protecting consumer rights in multiple areas.
Tang stressed that STC has successfully extended its professional testing and certification services to other regions, allowing companies offering exceptional products in other places to be recognized by our rigorous certification schemes.
With the aim of sharing the change and challenge of ISO10993-1 :2018, STC delivered a seminor on May 16, 2019 on Medical and Healthcare Fair at Hong Kong Convention and Exhibition Centre.
This year, STC is delighted to join this Fair and share our expertise in testing and certification.
Hosted by the People’s Government of Guangxi Zuang Autonomous Region, the “Presentation on Guangxi Integrating the Guangdong-Hong Kong-Macao Greater Bay Area – Hong Kong 2019” Ceremony was held on May 15, 2019 at the Hong Kong Rosewood Hotel. Mr. Richard Fung, Chief Executive of STC, presented “STC Tested” Mark certificates to 8 Guangxi companies, whose “Guangxi specialty” goods have been approved by the well-recognized product quality certification scheme.
The event was witnessed with the presence of Mr. Leung Chun-ying, Vice Chairman of the National Committee of the Chinese People's Political Consultative Conference, and Ms. Lam Cheng Yuet-ngor, Chief Executive of the Hong Kong Special Administrative Region, as special guests. They congratulated the successful signing of the agreement on economic and trade cooperation between Guangxi and Hong Kong, and looked forward to a mutually beneficial future built on the deepening ties between the two places.
Richard Fung: “We are looking forward to cooperating with more Mainland Chinese enterprises, and will continue to promote product quality and safety in the Mainland and help ensure a high quality of life for the people through the “STC Tested” Mark Certification Scheme.”