In accordance to carry out product supervision of Medical Devices and Household Health Supplies (PKRT) with Law Number 17\/2023 concerning Health, The Ministry of Health issued Circular Letter Number HK.02.02\/E\/2379\/2023 on December 5th. This circular letter is regarding the list of medical device and PKRT testing laboratory networks that have been accredited with SNI ISO\/IEC 17025:2017. The availability of these laboratories aims to support the quality assurance of medical devices and PKRT through pre-market and post-market testing, including domestic products.<\/p>\n\n\n\n
To ensure that medical devices and PKRT meet the safety, quality, and benefit requirements, it is important to rely on accredited testing laboratories. The list of testing laboratory networks listed in Annex 2 of circular provides complete information on laboratories that have obtained SNI ISO\/IEC 17025:2017 accreditation. This accreditation covers the scope of medical device and\/or PKRT testing.<\/p>\n\n\n\n
The owner of the product approval \/ license holder, as one of the relevant stakeholders, can utilize this list of laboratories to ensure that their products have undergone rigorous testing and are in accordance with applicable standards. Pre-market and post-market testing will help ensure the safety and quality of products, including domestic products. This laboratory network is an integral part of efforts to monitor and improve the quality of health products.<\/p>\n\n\n\n
It is important to note that the list of laboratories as well as information related to products, test types, and test methods will be updated regularly. This update will be carried out in line with the development of strengthening the network of medical device and PKRT testing laboratories. This is done in order to always maintain its relevance and be able to accommodate the latest developments in the health sector.<\/p>\n\n\n\n
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