Research Use Only

In accordance with the mandate of the Minister of Health Regulation No. 62 of 2017 concerning Distribution Permits for Medical Devices, Medical Devices In Vitro Diagnostics and household products, that requirements for safety, quality and benefits of Supplies Household Health (PKRT) must be met before circulating in Indonesia.

As a support for distribution permit services There is also a certificate service for Reseach Use Only regarding the import of medical devices and PKRT Certificate for Reseach Use Only Medical Devices and PKRT is obtained after fulfilling the requirements administrative and technical by the Assessment Team from Indonesia Ministry of Health.

The certificate provided for the product to be used in research (Research Use Only/RUO). RUO (Research Use Only) are medical devices and medical devices In Vitro Diagnostics currently under development research and has not been approved for clinical use or declared as RUO products by the relevant agency authorized in the country of origin of the manufacturer.

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