Writer | Dra. Rully Makarawo, Apt., [et al.] | |
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Publisher | Ministry of Health RI | |
Year | 2021 | |
ISBN | 978-623-301-243-0 | |
Dimension | ||
Number of Pages | 46 | |
Description | Changes to medical devices and in vitro diagnostic medical devices may occur during the lifecycle of medical devices and in vitro diagnostic medical devices. Changes that occur in medical devices and in vitro diagnostic medical devices that have been registered must meet the principles of safety, quality and benefits/performance. In order to ensure the safety, quality and continued usefulness/performance of medical devices and in vitro diagnostic medical devices, manufacturers/manufacturers/applicants should assess the effects/impacts of changes on patients, health workers, and users of medical devices and in vitro diagnostic medical devices, and determine whether these changes will have an effect/impact on the safety, quality, and usefulness/performance of such medical devices and in vitro diagnostic medical devices (div). |