In Nov.7,2017, Shanghai government issued Pilot Project of Medical Device Registrant System in China (Shanghai) free trade experimental area, and this registrant system was formaly launched in Shanghai as a test run. The medical device registrant system means a qualifed registration applicant of medical device can be treated as a independent registrant of a medical device who owns certificate of the medical device which is even not produced by itself. The registrant can outsource production of the medical device to qualified manufacturer. Now the Chinese State Council officially issued thedocuments to extend the registrant system to Guangdong and Tianjin. So there is a magnificent reform in medical device industry and development of CDMO is being accelerated.
What is CDMO? i.e. Contract Development and Manufacturing Organization. It is a kind of facilitating agency that specialize in the new-style R&D outsourcing, which mainly offering proffesional service to the products of medical manufacturers and biotechnology corporations, especially the innovative products, which including R&D and preparation, process optimization, customized production for registration testing and clinical trial, commercial customization.
In 2018, the business of MedicalStrong was upgraded from CRO to CRO+CDMO in order to form an integrated service platform providing one-stop resolution at every stage from design to final controls. This service is divided into 3 phases. Until now, the 1st phase of GMP purification workshop (covers 1,000m2) for IVDs is preparing in Pudong new district of Shanghai. When completed, it can provide the services such as R&D and production of biochemical reagent, POCT, mass spectrum. During the 2nd and 3rd phases, the active, passive, high-risk implant medical device (Class Ⅱ and Ⅲ) will be added into our line in future. Distinguished from traditional CDMO, we make some adjustment about “D” and “M” and make the pattern of it more multiple such as cooperative development, contract development, independent development.
Service Items
R&D outsourcing
Customized production for registration
Product line and facility sharing
QC system tutorship
Completed resolution for the product