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List of 28 in Vitro Diagnostic Reagent Registration and Clinical Trial CRO Service Providers

2021-01-11
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Similar to medical CRO companies, medical device CRO services are essentially a form of service outsourcing. Attached to the medical device industry, the upstream is medical institutions that provide clinical data for medical devices, and the downstream is medical device companies. The main source of business in the industry is the entrustment of medical device companies and medical device developers.

Internationally, the concept of medical device CRO is not very common. Most large pharmaceutical companies have medical device divisions or teams in subdivisions. In the domestic CRO market for medicines and medical devices, the medical device industry market started relatively late, but the current service providers focusing on CRO in the medical device segment are on the rise. Medical device products are highly specialized and have high barriers to entry, so device CRO There is still room for development in the market.

According to the “China Medical Device CRO Industry Analysis Report”, my country’s medical device companies generally have a long product development cycle, but there are many product innovations, with more than 27,000 registrations per year. In the environment where the medical device industry market can be expected, the device CRO industry that relies on and serves medical device companies deserves market attention.

Based on the data collected by CRO companies in the slide APP and the survey data of in vitro diagnostic companies participating in CACLP Expo, the editor has sorted out some of the CROs involved in in vitro diagnostics in medical devices for reference. Welcome to leave a message and recommend!

▷Taizhou Taige Jietong Pharmaceutical Technology Co., Ltd.

Tigermed

In 2016, Hangzhou Tigermed Pharmaceutical Technology Co., Ltd. (stock code: 300347) acquired the domestic leading medical device CRO Jietong Tairui, set foot in the field of medical devices, and completed a strong alliance in the field of CRO. After the merger, TAGJietong focuses on medical device CROs. Its core service is to provide medical device (including IVD) companies with required clinical research outsourcing services for the development of related medical device products, mainly including medical device registration and declaration services, medical Technical services for clinical trials of devices and recruitment services for medical device professionals.

▷Ozida Medical Device Service Group

Founded in 2004, it is the world’s leading provider of medical device services. The 3C industry platform covers the three major functions of medical device vertical professional incubators, medical-industrial transformation centers and industrial innovation centers, providing medical device R&D, commissioned production, clinical trials, and global registration , Medical device cloud, industrial planning and other professional services. The company has a strong medical device professional database, project management platform, and R&D and manufacturing base (active device production base, passive device production base, diagnostic reagent production base) to provide global medical device developers, enterprises, and governments with a full range of One-stop medical device industry solutions.

▷Wuxi Wuxi AppTec New Drug Development Co., Ltd.

Wuxi apptec

Founded in 2000 and listed in 2018, the first domestic CRO company with a level of 100 billion was born (stock code: 603259). The company’s medical device testing platform is also part of the laboratory service business in the US, which originated from the merger after the acquisition of AppTec. The platform runs through the entire industrial chain of medical device R&D and production, including preclinical safety consulting services, medical device testing services from design to commercialization, and medical device cGMP production services. The business scope covers material selection and evaluation, material characteristics, risk assessment, biocompatibility, toxicology, disinfection/inactivation verification, packaging integrity verification, raw material verification, batch release testing and other services.

▷Rundong Pharmaceutical Research and Development (Shanghai) Co., Ltd.

Established in 2004, it is the first Sino-foreign joint venture CRO company in China. It is also the first CRO company in the domestic CRO industry to pass the ISO 9001:2008 quality management system combined with the CRO industry standard certification. The research involves various fields of clinical research such as tumor, cardiovascular, respiratory, digestion, endocrine, nerve, and anti-infection. The company’s abundant resources for clinical research provide customers with high-quality and efficient one-stop clinical research services that comply with ICH-GCP and NMPA related regulations.

▷Guangzhou Jiutai Pharmaceutical Technology Co., Ltd.

Established in 2016, it is a wholly-owned subsidiary of Guangzhou Boji Pharmaceutical Biotechnology Co., Ltd. It is a CRO specializing in third-party outsourcing services for medical devices. Relying on the 16 years of clinical trial experience of the parent company, we have rich practical experience in three types of high-risk medical device clinical trials, regulatory consultation and training, system establishment and verification, and import registration. The services of Jiutai Medical Devices include medical device clinical trials, NMPA registration, pre-clinical animal experiments, system construction, training and other content related to third-party outsourcing services for medical devices.

▷Wuhan Zhizhong Technology Co., Ltd.

Founded in 2011, it has been recognized and invested by Tsinghua TusHoldings Ventures and Matrix Partners China. Passed the ISO9001 quality management system, ISO27001 information security system certification, obtained the China National Certification and Accreditation Administration Commission Inspection and Testing Agency Qualification Certification (CMA) certificate, and introduced the advanced SAP project process management system and the Esaitong data encryption system. Zhizhong focuses on providing professional and systematic technical consulting services for industry enterprises, and can provide integrated solutions such as “technical regulations, clinical trials, R&D and testing, contract manufacturing and incubation services”.

▷Kuntuo Xincheng Pharmaceutical Research and Development (Beijing) Co., Ltd.

Established in 2011, Kuntuo has provided a full range of clinical research services for many international and domestic pharmaceutical companies, medical device and in vitro diagnostic reagent companies. The therapeutic areas involved in clinical research include tumor, psychiatry, digestion, cardiovascular, endocrine, anti-infection, etc.; medical equipment and in vitro diagnostic reagent services involve cardiovascular, orthopedics, endocrinology, hemodialysis, medical beauty and other fields.

▷Medistron (Beijing) Technology Development Co., Ltd.

Founded in 2011, it is a regulatory consulting company specializing in the registration and application of medical devices, providing enterprises with a one-stop solution for all-round medical device registration and clinical trials. The service content includes: product registration and application, clinical trial research, animal test plan design and implementation, production system guidance, GMP plant design and construction, new product design and development verification and technology transfer, measurement certification and other projects.

▷Xiamen Frida Medical Equipment Technology Service Co., Ltd.

Founded in 2012, it focuses on the field of medical devices, and efficiently operates various product registration and clinical trial research affairs and other professional services and solutions for the venture/investors in the industry, and improves customers from product development to post-marketing. Probability of success in one step. After years of intensive cultivation, Frida has perfected the quality management and quality control system, realized effective prediction, avoidance and resolution of possible problems in product testing, registration, clinical and other links, and ensured that the project process meets NMPA requirements.

▷Novolan Biotechnology (Beijing) Co., Ltd.

Established in 2008, it is committed to providing medical device companies with the most valuable regulatory consulting and compliance solutions to help customers gain a sustainable competitive advantage in the Chinese market. Provide medical device companies, practitioners and regulatory agencies with regulatory information and analysis, response consultation and resolution, application support and agency, compliance management and auxiliary services in the field of medical devices and in vitro diagnostics.

▷Beijing Golden Yiqiao Technology Co., Ltd.

Founded in 2008, it is committed to the registration of various regulatory affairs for international medical device manufacturers in China, the United States, Europe, Japan and other countries, and has successfully obtained sales licenses in China, Europe and Japan. The in-vitro diagnostic reagent registration department provides NMPA medical device, in vitro diagnostic reagent regulatory affairs registration, NMPA domestic clinical trials, FDA 510K registration application, CE Marking registration application, Japanese MHLW listing application, in vitro diagnostic reagents, medical device registration consultation and other services.

▷Haihe Biomedical Group Co., Ltd.

Haihe Consulting was established in 2005, and its subsidiary Haihe was established in 2015. It is established in accordance with the international standard ISO17025 and the United States 21 CFR Part 58 good laboratory specifications. It can carry out rat, mouse, guinea pig, Rabbit, dog, sheep, pig and other animal testing, provide biocompatibility testing, microbial testing, process confirmation and preclinical animal testing services.

▷Beijing Aotaikang Pharmaceutical Technology Development Co., Ltd.

Founded in 2006, the company is committed to becoming a leader in MA solutions in the pharmaceutical industry, providing research and development, clinical trials and registration consulting services for pharmaceutical and medical device companies. The Group’s CRO platform has completed more than 500 clinical trials and registration services for drugs and medical devices, and successfully applied for 12 national innovative medical device approvals. The service items involve inspection, cardiovascular system, nervous system, ear, nose and throat, obstetrics and gynecology, digestion System, tumor and many other fields.

▷Yongming Chengdao (Beijing) Medical Technology Co., Ltd.

Founded in 2009, it is a clinical full-service organization focusing on the field of medical devices. The company is committed to providing complete solutions in the fields of clinical trial management, data management, core laboratories, biostatistics analysis, IT innovation and medical media communication. Clinical research management services are the main business of CCRF, providing clinical research management services for medical devices and drugs, including pre-marketing and post-marketing clinical trials, registration (phase I-IV) clinical research monitoring and evaluation.

▷Sigma Pharmaceutical Technology Co., Ltd.

Founded in 2009, it is an innovative contract research organization specializing in the clinical research of medical devices. It is committed to providing clinical trial services, clinical research, plan writing, statistical analysis, data management, monitoring, third-party audits and Overall solutions such as registration declaration. Involved in more than 10 main therapeutic areas, such as IVD, orthopedics, ophthalmology, intra-renal, etc., it has worked closely with 80% of clinical trial institutions across the country and successfully completed more than 300 clinical trials of medical device II and III products.

▷Fine (Tianjin) Pharmaceutical Development Co., Ltd.

Founded in 2007, it is an international CRO company that can provide clinical development services in line with ICH standards. It is committed to providing domestic and foreign pharmaceutical and medical device customers with registration affairs, medical affairs, clinical operations, data management and biostatistics, and drugs One-stop clinical research related services such as vigilance and third-party inspections have passed the inspections of more than 60 internationally renowned pharmaceutical and medical device companies, participated in and undertaken the registration, declaration, clinical application of more than 85 innovative drugs and nearly 20 biosimilars. Design and development work.

▷Shenzhen Golden Eagle Enterprise Management Consulting Co., Ltd.

Established in 2007, the medical device field provides services including: domestic NMPA class II medical device business registration and class III business license, domestic NMPA class II and class III medical device product registration and production license; domestic NMPA class II and class III import registration; quality On-site management system counseling, customer factory inspection, management review, FDA Class I and Class II registration, EU CE certification, Australian TGA product registration, Japanese JPAL, South Korea KFDA product registration and legal system establishment and other technical services.

▷Presun (Beijing) Pharmaceutical Technology Development Co., Ltd.

Founded in 2010, it is committed to providing a comprehensive range of precision clinical research service solutions that meet international standards and make full use of personal connections and regional resources. It is a comprehensive clinical research service company that can not only provide local services, but also directly provide overseas transnational services. The CRO field has participated in more than 1,000 clinical studies, and has a leading data statistics team in China, a professional medical device clinical research service team, a comprehensive medical support team, and rich NMPA defense experience.

▷Shenyang Weida Biotechnology Co., Ltd.

Founded in 2010, it is a professional service company focusing on medical device clinical trial agency and registration and listing services. The group consists of Shenyang, Beijing, Shanghai and Suzhou companies. The company provides: clinical trial agency, medical device product registration, medical biostatistics and other consulting agency services for Class II and Class III medical devices, dressings, consumables and other products.

▷Shenzhen Longde Biological Technology Co., Ltd.

Founded in 2011, it is committed to providing complete solutions for medical device consulting and product services for medical device manufacturers, distributors, medical institutions, industry regulatory and investment institutions. The company’s business covers medical device operation, process, R&D, production, quality, clinical trial research CRO, regulations and other medical device consulting, medical device registration agency, medical device multilingual translation, and medical device industry information research.

▷Beijing Xinzhida Medical Technology Service Co., Ltd.

Founded in 2015, focusing on the field of medical devices, providing a full range of technical consulting services for medical device companies. The scope of services covers pre-investment market research and analysis of the medical device industry, park promotion and docking, system construction at the R&D stage, and clinical trials of medical devices , IVD product clinical trials, medical device and IVD product registration, medical device consulting, GMP system counseling, medical device industry training, ISO13485 certification consulting, ISO15189 accreditation consulting, product management and use consulting, etc.

▷Guangzhou Xiangkang Medical Equipment Technology Service Co., Ltd.

Founded in 2015, it provides technical services for the entire industry chain for medical device manufacturers. Technical services include policy consultation, plant design, registration inspection, clinical trials, physical examination consultation, and regulatory training. The company has a high-quality professional technical team and strict SOP operations. It is well-versed in national policies and regulations, application procedures and corporate management to provide medical device manufacturers with the highest quality and reliable technical services throughout the industry chain.

▷Shanghai Jiushun Enterprise Management Technology Service Co., Ltd.

Founded in 1996 and headquartered in Shanghai, it has now developed into a group company, including two wholly-owned subsidiaries in the UK and the Netherlands. Medical device certification business includes: ISO13485, YY/T0287, CE, PPE, FDA-510(K), QSR820, FDA 21 CFR 210&211 cGMP, CMDCAS, PAL, TGA; medical device registration business includes: domestic registration certificate, production license , Business license, import registration certificate, in vitro diagnostic reagent registration certificate.

▷ Shengen (Beijing) Pharmaceutical Technology Co., Ltd.

Founded in 2015, it is a CRO company specializing in registration consulting and clinical trial services. The core team members of the company have more than eight years of clinical trial experience and registration experience, completed dozens of clinical trial projects, and successfully obtained registration certificates, especially in the field of cardiovascular, peripheral vascular, orthopedics, neurointervention, and gastroenterology , Rich experience in the field of respiratory medicine and plastic surgery.

▷Nanjing Huitong Medical Technology Co., Ltd.

Founded in 2015, it is a CRO consulting service group company specializing in medical device research and development, registration, clinical trials, and system certification. With 14 years of service experience in the field of medical devices, it has established branches in Beijing, Nanjing and Guangzhou, China. Huitong Medical has self-developed medical device registration and evaluation system, medical device clinical data collection system, medical device clinical trial statistical analysis system, and has successfully provided more than 2,000 products and services to more than 400 domestic and foreign companies.

▷Hangzhou Maidianlian Medical Technology Co., Ltd.

Founded in 2017, the company has many years of development history and regulatory consulting experience, and has successfully helped more than 1,000 domestic and foreign medical device manufacturers obtain medical device registration certificates. At present, the company’s main business is medical device registration, testing follow-up, clinical trials, product investment and exhibition preparation. At the same time, it provides customers with one-stop product registration solutions, including annual regulatory training, policy interpretation of independent cases, on-site technical training support, and contract solutions for different products.

▷Suzhou Deda Enterprise Management Consulting Co., Ltd.

Founded in 2015, the company is committed to providing professional consulting services for medical device technology transformation, including: medical system certification; patent services; information technology, biotechnology consulting, communication services; market research services; new material technology development services; clinical trials ; Domestic and foreign product registration guidance; license declaration service and industrial park cooperation.

▷Jiangsu Deneng Medical Technology Co., Ltd.

Founded in 2016, it is a CRO information service group company specializing in medical device clinical trials, CFDA registration, US FDA, and EU CE certification. The group has a total registered capital of over 40 million yuan, and has established six wholly-owned subsidiaries in Beijing, Shenyang, Shanghai and Suzhou.

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