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Medical device regulations
State registration of medical devices is a mandatory procedure, without which it is impossible to enter the market for products, their free sale, purchase and use.
During the procedure, the quality of the devices is checked and their compliance with the current norms and standards. Only truly high-quality and effective medical devices successfully pass all checks and are entered into the register.
Pharmaceutical regulatory issues
During the registration process, medicines are checked for compliance with the declared characteristics, undergo preclinical and clinical trials, as well as pharmaceutical expertise to identify all types of risks.
The procedure is carried out in such a way as to exclude the possibility of unexpected side effects and other effects before using a new medicine. Registered medicines are guaranteed to be effective and safe.
Regulation of in vitro diagnostic devices
The FDA classifies medical devices, including in vitro diagnostic devices, into Class I, II, or III according to the level of regulatory control necessary to reasonably ensure safety and efficacy. The IVD (or other medical device) classification determines the appropriate pre-sale process.