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    Singapore HSA will introduce UDI labeling requirements for medical devices
    Singapore’s Health Sciences Authority (HSA) has announced that it will introduce a Unique Device Identification (UDI) system to be used for medical devices. The announcement came during an industry briefing held on October 19, in which the HSA outlined th
    SUNGO gained a lot in CMEF 2020
    The 83rd China International Medical Device Expo (CMEF 2020) concluded today.SUNGO gained a lot in this exhibition.During the exhibition, we communicated with old customers about project plans, negotiated with partners about future plans, and reached serv
    SUNGO helps customers get a MDR certificates!
    After the festival came the good news: The customer of SUNGO providing technical services nanchang Hye Health Material Co., LTD successfully obtained the MDR certification of sterilizing mask issued by BSI. Our services for this client include CE MDR cert
    MHRA announces a proposed framework for international recognition of medical devices
    Swissmedic is preparing to launch Swissdamed
    Following the breakdown of the bilateral framework agreement between Switzerland and the European Union (EU), Swissmedic is preparing to launch Swissdamed, a Swiss registry database that will cover economic operators and medical device registrations.
    SUNGO guided a customer for device registration
    Recently, SUNGO guided a customer for device registration. And the device abdominal paracentesis was successfully approved by FDA and obtained 510K in only 51 days.
    the US FDA officially opened the US FDA Cosmetic application system -FDA Cosmetic Direct
    ​On December 16, 2023, the US FDA officially opened the US FDA Cosmetic application system -FDA Cosmetic Direct, which means that all enterprises that have sold or plan to sell cosmetics in the United States must complete the REGISTRATION OF COSMETIC PROD
    the FDA issued the final version about the QSR820
    On January 31, 2024, the FDA issued the final version about the QSR820, adopting the relevant requirements of the international standard ISO13485:2016 for medical device quality management system, and renamed QMSR quality management system regulations.
    CFG-NE certificate (Certificate to Foreign Government for Device Not Exported from the United States)
    In the world, including Japan, Singapore, Mexico, Costa Rica, Australia and other countries and regions, the medical device products listed in the United States have a general recognition, this recognition is not only reflected in the medical device produ
    The FDA fee for 2022 has been set
    On August 2, 2021, the US FDA officially announced the fee standard for 2022. Among them, the annual fee for FDA enterprise registration and device listing and 510(K) declaration fee have a greater impact on Chinese manufacturers, and both of these fees h
    Post-Brexit medical device and IVD oversight: A new plan for the UK MHRA
    The British authority for medical products, MHRA, has published its Delivery Plan 2021-2023. Normally MHRA publishes a new Delivery Plan every five years, and the most recent version was from 2018.
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