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Medical Strong’s CRO+CDMO One-stop Service Platform
MedicalStrong, founded in 2011, is a multi-service supplier which provides the professional service such as registration application of medical device in Chinese market, consultation for clinical investigation etc. We have a headquarter in Beijing and some branch offices in many cities throughout China such as shanghai, Tianjin, Guangzhou, Chengdu, Wuhan, Shenyang etc. to benefit the global clients with one-stop service of NMPA registration for their medical products.
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The medical products related to our services almost cover all medical departments
All medical device products which are sold in Chinese market must be under supervision of National Medical Products Administration (NMPA). The manufacturers of imported medical device must acquire the registration certificate issued by NMPA for their products. At the same time, it is necessary to open an office or designate an agent in China to ensure all submitted materials meet the requirement of NMPA regulations.
Clinical investigation is an unpredictable step of registration application duration, which need much more time and investment. We help clients make accurate prediction from very beginning to avoid any incidents and reprocessing. Our dependable operating and management system with strict QC SOP can ensure every project run smoothly.
Also called as clinical evaluation report. Clinical equivalence evaluation of medical device refers to the process that the applicant or the filing applicant validates whether a product can meet the operating requirements or scope of application or not through clinical literature, clinical experience data, clinical trial and other information.
The medical device registrant system refers to the system that a qualifed registration applicant of a medical device can be treated as a independent registrant who owns the certificate of this medical device which is even not procudced by itself, Then the applicant can outsorce production of relevant medical device to qualified manufacturer.
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