On 21st February 2023, the Indonesia Ministry of Health (MoH) has issued a circular letter with no HK.02.02/E/359/2023 concerning “The Implementation of Quick Response (QR) Code in the Rapid Diagnostic Test (RDT) Antigen COVID-19 using the Nasal Swab Method with Self-testing Claim.”
The circular letter regulates new requirements for the labelling of RDT Antigen COVID-19. Business actors who own marketing licenses of the RDT Antigen COVID-19 Nasal Swab Method with self-testing claim are urged to apply for an amendment application to comply with this new requirement.
In connection with the circular letters, the following information is specified in detail:
- 1. Product (RDT Antigen COVID-19) Criteria:
- a. Has a distribution permit issued by the ministry of health (which can be seen via http://infoalkes.kemkes.go.id/)
- b. RDT Antigen COVID-19 nasal swab method with self-testing claim.
- c. Listed QR Code from MoH. The QR code contains a unique code for each product, as a product identification, so that it is traceable and cannot be reused.
- 2. Apply for amendment application of the marketing license through the REGALKES system to include self-testing claims on the secondary and primary packaging, as well as including the placement of the QR Code on the primary packaging / cassette of the RDT Antigen COVID-19.
- 3. Provide packaging for RDT Antigen COVID-19 with a QR Code in the form of a single pack.
- 4. Provide instructions for using self-testing COVID-19 Antigen RDTs.
- 5. Provide all equipment starting from the process of preparing kits / tools to waste disposal.
- 6. Apply for a QR Code through the One Health (Satu Sehat) platform connected to the Peduli Lindungi application.
Application for QR Code through the “One Health” platform must be done by the marketing license owners and the QR Codes are unique to one marketing license.
Circular letter no HK.02.02/E/359/2023 concerning The Application of Quick Response (QR) code in the Rapid Diagnostic Test (RDT) Antigen COVID-19 using the Nasal Swab Method with Self-testing Claim