Exemption principles (a) Class II management of low-risk medical devices; (b) medical devices work (role) mechanism is clear, the design is finalized, the process is mature, widely used in clinical applications; approved by the Food and Drug Administration to market similar products have been on the market for more than four years (including four years), the marketed products do not see the report of serious medical device adverse events and/or product defects; (c) to ensure that the medical device (C) to ensure the safety and efficacy of medical devices performance characteristics indicators, such as physical indicators, chemical indicators, biological evaluation indicators, etc. in the product registration standards have been correctly established; similar product registration standards have been the provincial (food) drug supervision and management department or its authorized departments to review; in line with the above standards for product registration of medical devices is sufficient to ensure that the product is safe and effective; (D) to apply for exemption from clinical trials of the material of the medical device, work (D) to apply for exemption from clinical trials of medical devices material, work (role) mechanism, structural composition, the main technical performance indicators, manufacturing process, sterilization methods, intended use, operation of the object and the use of safety, efficacy and other aspects of legally marketed similar products with substantial equivalence; (E) the State Food and Drug Administration has been expressly exempted from the clinical trials of medical devices. Provinces will generally be published in accordance with the principle of exemption directory, want to be exempted from the local provincial Drug Administration must seek advice, or there may be trouble, because the clinical cycle is long, to make up for the delay.
Auqida consulting organization