In recent years, China has issued a series of policies successively to deregulate innovation, encourage and support R&D of innovative medical devices, including Opinions on Deepening Review and Approval System Reform and Encouraging Drug and Medical Device Innovation, and the Notice on Extending Pilot Work of the Medical Device Registrant System.
At present, relevant laws and regulations on medical devices worldwide change frequently and set increasingly strict requirements. The compliance cost soars. Tigermed-Jyton can provide full lifecycle regulatory services on IVD products for the client and guarantee product compliance.
Responding to the call of R&D innovation and new technique popularization and application, Tigermed-Jyton actively promotes high quality development of the industry. To promote efficient launching of products, we provide the innovation application service for conforming products in accordance with the Special Review Procedure of Innovative Medical Devices.
Each country implements classified and graded management for products with different risks. The regulation and control over R&D, manufacturing, operation, registration and full life cycle in clinic is different for products in different categories. To avoid over or insufficient management caused by ambiguous product classification and to provide references for regulatory authorities and reasonable···
According to Administrative Measures for IVD Reagent Registration, in addition to registration or filing, we also:• Contact the corresponding food and drug administrations, foreign applicants or filing entities;
Reflected in laws and regulations, different countries have different risk classifications and review requirements for medical devices. The reform of the review and approval system for medical devices is deepening constantly in China.
Tigermed-Jyton is experienced in providing clinical trial services for medical devices. Tigermed-Jyton can provide clinical technology services including clinical trial, evaluation and scientific research, etc. for the client in accordance with current regulations, GCP and corresponding guidelines:
•Coaching on complying with the registrant system by the MAH•ISO 13485 and ISO 9001 certification guidance•Full lifecycle quality system service•GMP workshop design coaching and on-site audit•Product production and quality control unde
Entrusted Test1. OverviewThe entrusted test can be resorted to when the testing purpose cannot be realized by self-test, The entrusted testing institution should have corresponding inspection ability. With respect to NMPA registration, the entrusted test can be considered as the pre-test of re
Biological EvaluationFor the medical device intended to be used for human body, firstly, qualitative analysis on the material used and analysis on existing data or relevant information are performed before the clinical trial. Then simulated in vitrobiological test is performed. The in vivo&nbs