The 13th China International Medical Device Regulation Forum (CIMDR), one of the most grand annual events in the global medical device field, came to a successful close in Fuzhou. Representatives from medical device regulatory authorities and associations, and industry experts from home and abroad gathered together here, they delivered speeches and discussed measures and experiences in dealing with challenges to medical devices at home and abroad due to epidemics.
Ⅰ.March 2, 2023-Opening Ceremony
On March 2, 2023, the opening ceremony of 13th CIMDR was held, Mr. Chang Bin, the vice provincial governor in Fujian, attended and gave a welcome address, and Mr. Xu Jinghe, the vice director of NMPA, also attended and delivered a bless speech.
Earlier, Mr. Xu Jinghe was successfully elected as the chairman of the 27th Global Harmonization Working Party (GHWP) at 4:00 PM on February 16, 2023, Riyadh time. In this CIMDR conference, the election was formally announced again, which is a grand mile stone in the process of internationalization of medical device regulation in China.
During this conference, it closely highlighted the current medical device regulatory focus. The new initiatives, developments and gains of medical device regulations and supervision in relevant countries and regions were shared through online and offline formats.
Ⅱ.March 3, 2023-The Trend of Global Clinical Trials of Innovative Devices of Structural Heart Disease
On the morning of March 3rd, Mr. Chen Zhenlang, General Manager of LINKS Medical Scientific(Shanghai)Co., LTD delivered his speech "The Trend of Global Clinical Trials of Innovative Devices of Structural Heart Disease" and indicated that: "The overseas market has larger space and more stable price than the domestic market. Since 1990s, the internationalization level of overseas medical device giant has shown a year-on-year improvement, which revealed a clear trend of medical device globalization in the past thirty years. Particularly, in the Unite States, the medical device companies seized the opportunity and made industry upgrades, some of them has been from the U.S. medical device giant to the global medical device giant. Thus it can be seen, conducting international multi-regional clinical trials (MRCT) for the medical devices registration is an important way to explore overseas markets in the future."
Ⅲ.March 3, 2023-Discussion and Prospects of Clinical Evaluation of Embolization Coils
On the morning of March 3rd, Ms. Huang Yimei, a Senior Medical Manager of LINKs , gave a presentation titled "Discussion and Prospects of Clinical Evaluation of Embolization Coils " and indicated that : "For the clinical evaluation of embolization coils for intracranial aneurysm, the scopes of application, technical characteristics, biological characteristics, level of risks and available research data (including clinical data and non-clinical data) of the product should be considered comprehensively. If the product is not a new medical device and equivalent to a similar product that is currently on the market. Please refer to the recommended paths of clinical evaluations of related products in the sub-catalogue 13 'Passive Implantation of the Device' in the Classification Catalog of Medical Device, which indicates the equivalent path for the clinical evaluation of embolization coils for intracranial aneurysm.
Ⅳ.March 3, 2023-Discussion and Prospects of Image Evaluation of Medical Device Core Lab 
On the morning of March 3rd, Mr. Pang Bo, the Medical Affairs Director of LINKs delivered his speech titled" Discussion and Prospects of Image Evaluation of Medical Device Core Lab" and indicated that, " Independent Review Committee (IRC) guarantees the objectivity and independence of endpoints assessment of clinical trials, it is widely used in premarket registration studies, real-world studies and clinical studies in medical devices. Combined with the characteristics of clinical trials, the efficiency execution of IRC will be improved by using digital image transmission technology, optimizing study design and its assessment process. At present, the evaluation standards and systems of IRC are not mature yet , and the industry standards and regulatory systems are expected to be established to promote the development of medical devices ."
Ⅴ.March 3, 2023-Dr. Li Wei, a professor from Fu Wai Hospital, and his team visited the LINKs’s exhibition stand
Ⅵ.March 4, 2023-Came to a successful close
LINKS CRO
As a CRO company providing clinical trial services. LINKS CRO focus on innovation, high-risk implantation(intervention) medical device, with one-stop clinical trial solutions for the whole process of medical device research and development.The headquarters of LINKS is based in Shanghai, with subsidiary branches in Beijing, Shanghai, Guangzhou, and Shenzhen, in addition to ten regional offices. The current workforce comprises almost 200 employees, with technical personnel making up over 85% and dispersed across almost 30 cities nationwide.
Key Services include CRO, SMO, CER, Audit, Post-market research, core laboratory registration both domestically and overseas, innovation declaration, Expert Consultancy, and overseas enterprise agency services.
Key Indications include Cardiovascular, Neurovascular, Peripheral Vascular, Surgery Robot, Oncology, Ophthalmology, Medical Cosmetology, and other fields such as orthopedics. There are almost 300 projects consultations and services by LINKS each year.
