Preparing a robust submission dossier is always a challenging work for the regulatory and compliance professionals in the medical device industry. The rapidly changing regulatory environment, as well as the constant evolution in compliance standards, has further complicated the submission tasks. This seminar aims to address the most critical pitfalls in regulatory submission and advise ways to avoid them.

Date: 20th September 2019 (Friday)

Time: 10:00am - 4:30pm

Venue: BSI Hong Kong, 23/F, Cambridge House, Taikoo Place, 979 King's Road, Quarry Bay, Hong Kong

Language: Cantonese & Mandarin

Fee: Free admission

2019年9月6日下午，香港標準及檢定中心（STC）聯合廣西壯族自治區市場監督管理局在廣西南寧中國-東盟檢驗檢測認證高技術服務集聚區共同舉辦了「攜手合作-共促廣西產品高品質發展論壇」，並舉行了隆重的揭牌儀式，廣西-香港標準及檢定中心有限公司正式成立。香港特別行政區行政長官林鄭月娥、廣西壯族自治區人民政府主席陳武、自治區人民政府常務副主席秦如培、香港政制及內地事務局局長聶德權、自治區市場監督管理局黨組書記馮學軍、局長巫家世、STC總裁馮立中、STC大中華區總監蔡愛寶、廣西產品質量檢驗研究院院長李暄等出席，廣西200家企業代表共約500多人參加了本次論壇。

會議正式開始前，林鄭月娥及陳武一行視察了集聚區的建設規劃情況，詳細了解了廣西質檢院、計量院、特設院、標準院服務廣西高質量發展情況、廣西與香港合作情況，參觀了STC廣西檢測認證基地各實驗室。

在會上，廣西壯族自治區人民政府主席陳武、香港特別行政區行政長官林鄭月娥分別致辭，在與會領導及嘉賓的見證下，廣西壯族自治區市場監督管理局黨組書記馮學軍與STC總裁馮立中共同簽署了《香港標準及檢定中心落戶廣西戰略合作協議》， STC成功落戶中國-東盟檢驗檢測認證高技術服務集聚區，充分發揮雙方互補優勢，在更大範圍、更寬領域、更高層次上深化合作，服務“一帶一路”，推動廣西積極對接融入粵港澳大灣區，服務桂港兩地經濟高質量發展。

簽約儀式結束後，舉行了隆重的揭牌儀式，由香港特別行政區行政長官林鄭月娥、廣西壯族自治區人民政府主席陳武共同為廣西-香港標準及檢定中心有限公司揭牌，標誌著廣西-香港標準及檢定中心有限公司正式成立，STC成功落戶廣西，通過合作共建一系列實驗室，開展檢測認證一體化服務，實現香港優質「正」印認證、香港綠色標誌認證、香港安全標誌認證在廣西“一站式”服務，助推更多廣西產品和檢驗檢測認證服務高效便捷走進香港、走向國際，為桂港兩地經濟高質量發展做出更大貢獻。

隨後又舉行了香港高端品質授證儀式，STC總裁馮立中為8家廣西企業代表頒發香港優質「正」印認證證書、香港綠色標誌認證證書和香港安全標誌認證證書。截至目前，已有56家廣西企業獲頒發香港優質「正」印證書，通過香港高端認證，走向國際市場。

STC在服務公眾的同時，也不忘肩負起貢獻社會的責任，通過積極參與社會慈善活動，與社區保持深厚關係，在今天的活動現場，STC總裁馮立中向廣西壯族自治區三江侗族自治縣捐贈扶貧資金10萬元，助力該縣經濟發展及民生改善。

STC’s Medical Device Laboratory has officially been approved and accredited as a GLP testing laboratory by the American GLP Regulatory Agency EMA-American 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

Media Enquiry:

Kevin Wang                                          

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

Email: kevinwang@stc.group

Market Enquiry:

Jonathan Tang                                       

Tel: +86 769 8111 9888 (ext.8288)