GeNose C19 is now in preparation to obtain the Indonesian National Standard (SNI). Both the GeNose C19 development team and National Standardization Agency (BSN) are currently working together to compile the required standards for the breathalyzer.
“BSN fully supports GeNose C19 as one of the COVID-19 detection devices. We will identify the standards needed to standardize medical devices like GeNose C19,” said Head of BSN Kukuh S. Achmad in an FGD to prepare for GeNose C19 standardization at the UGM University Club on Friday (30/4).
BSN is the only institution assigned by the government to coordinate standardization in Indonesia. During the process, the technical committee of BSN consisting of experts in certain fields will compile requirements and examine each component. The results of the FGD will become an input for the committee in determining the standards. According to Kukuh, as the SNI for medical devices also refers to international standardization, GeNose C19 may have the opportunity to meet overseas requests if the breathalyzer passes the process.
President Director of Swayasa Prakarsa, Iswanto, added that each unit of GeNose C19 has met the standards set by the Ministry of Health through the issuance of its distribution permit and passed the diagnostic test. Apart from preparing for SNI, GeNose C19 is currently in the external validation stage conducted by an independent team from Andalas University, Universitas Indonesia, and Airlangga University. It is also one of the travel requirements set by the Indonesian government. By being SNI-certified, public trust in GeNose C19 will increase.
“We will note BSN advice and recommendations to improve the quality of GeNose C19 and provide a much better quality assurance,” explained Iswanto.
Regarding the uneven use of GeNose C19 in health facilities, Iswanto explained that Swayasa Prakarsa, as the device manufacturer, would increase its production capacity in June to expand distribution to other sectors outside transportation.