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عمومی::
سازمانهای تنظیم مقررات سختگیرانه
Although international standards exist and Stringent Regulatory Authorities (SRA) regulate prosthetic components, SRA approval processes generally allow for self-declaration of conformance instead of evaluation of a regulatory dossier.
In addition to SRA approval, some LMICs have regulatory processes for registration of medical devices which may or may not include prosthetics.
These gaps - 1) limited SRA oversight; 2) lack of LMIC considerations in standards; and 3) the high cost of testing to standards - lead to a lack of visibility on the quality of components in the market for LMIC providers.
Since SRA approvals, such as CE and FDA, are obtained through self-declaration with minimal oversight, not all components from a supplier may have undergone the same durability testing.
As such, providers cannot rely on SRA approvals to indicate quality and performance of different components, leaving prosthetists to rely on anecdotal feedback or ad-hoc field testing.
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