SERTIFIKASI PRODUK (SNI) ALAT KESEHATAN DAN ALAT KESEHATAN DIAGNOSTIK IN VITRO SECARA WAJIB

The number of manufacturers of medical devices and In Vitro Diagnostic medical devices that already have SNI certificates is currently very limited.The purpose of this paper is to illustrate that Product Certification (SNI) of Medical Devices and In Vitro Diagnostic Medical Devices by mandatory is needed because SNI sertificate as proof that the medical devices have met the standards in accordance with the standards claimed by the producers, especially those related to safety and performance based on the results of accredited laboratory tests as mandated by regulation No. 36 of 2009 concerning Health and regulation No.20 of 2014 concerning Standardization and Conformity Assessment so as to increase market confidence in both domestic and global markets.Product Certification (SNI) of Medical Devices and In Vitro Diagnostic Medical Devices for Domestic is expected to be one of the requirements to Market License (izinedar) as proof of compliance with standards-based regulations.The proposal for the issuance of the regulation on mandatory product certification (SNI) for Medical Devices and In Vitro Diagnostic Medical Devices by ministry of health by taking into account the availability of Conformity Assessment Body such as the Accredited Medical devices and In Vitro Diagnostic Medical Device Product Testing Laboratory and the accredited Medical devices and In Vitro Diagnostic Medical Device Product Certification Body (LSPro).