On August 23, 2023, the official website of Center For Medical Device Evaluation of the National Medical Products Administration released the results of the special review application for innovative medical devices (No. 6 of 2023). On September 7th, the Implantable Cardioverter Defibrillator (ICD) from Singular Medical passed the public notice period and officially entered the special review process (i.e. "Green Channel"). This product is the first implantable cardioverter defibrillator (ICD) product to enter the innovative special review process.
Three basic conditions must be met to enter the special review process for innovative medical devices：
（1） The applicant, through their leading technological innovation activities, legally owns the core technology invention patent right of the product in China, or obtains the invention patent right or its usage right in China through acquisition in accordance with the law. The special review application for innovative medical devices shall not exceed 5 years from the date of patent authorization announcement; Or the patent application for core technology invention has been disclosed by the patent administration department under the State Council, and the patent search and consultation center of the China National Intellectual Property Administration has issued a search report, which indicates that the core technology solution of the product has novelty and creativity.
（2） The applicant has completed preliminary research on the product and has a basic standardized product. The research process is authentic and controlled, and the research data is complete and traceable.
（3） The main working principle or mechanism of the product is pioneering in China, and its performance or safety has been fundamentally improved compared to similar products. It is at the international leading level in technology and has significant clinical application value.
The introduction of special review procedures for innovative medical devices and the establishment of innovation approval channels will enhance the interaction between evaluation center and enterprises, and the priority approval process will greatly accelerate the registration and launch of products. In addition, a series of policies introduced by the national and local governments will also provide a better development environment and guarantee for innovative products.
Congratulations to Singular Medical for the Implantable Cardioverter
Defibrillator (ICD) approved for special review of innovative medical devices!
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.
