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ANNOUNCEMENT
Local Test on Rapid Diagnostic Test (RDT) Antigen for Covid-19
On February 14, 2022, the Ministry of Health of the Republic of Indonesia announced that for new applications and extensions of registration for distribution permits of both domestic and imported Covid-19 RDT products, it is mandatory to attach the results of a minimum validation test from one designated test laboratory. This requirement is in accordance with the Decree of the Minister of Health of the Republic of Indonesia number HK.01.07/MENKES/477/2021, which pertains to the Testing Laboratory for the Validity of the Rapid Diagnostic Test of Antigen (RDT-Ag).
Please note that the validity period of the validation test results is three months from the date of submission of a new or extended application.
For more information, please visit: REGALKES
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Our Services
- License Representative
- Product Registration
- Medical Device Company Establishment Service
- Miscellaneous Certificates
- Post-Marketing Surveillance
- E- Catalogue
- Medical Device Trademark Management
- Regulatory Intelligence
- License Representative
- Renewal and License Amendment
- IDAK (Izin Distributor Alat Kesehatan)