Simple, fast and reliable! SUNGO has completed CE registration for 79 IVD reagent products
On January 3, 2022, 79 IVD products of our client in Nanjing have been approved by German authority, which means that the client will be able to continue to export its products to the EU market for 3-5 years under the framework of the IVDD Directive.
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 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
Certificate of Free Sale—Global Pass of Medical Devices
At the present stage, Certificates of Free Sale for COVID-19 testing reagent products are the most popular. Statistic shows that SUNGO has obtained on behalf of clients more than 500 CFS certificates from the Authorities of the Netherlands, the UK and Ger
How to distinguish between FDA registration, FDA certification, and FDA testing?
In 2022, the epidemic situation in the United States is more serious, which brings a larger medical device market. Many customers may have questions on how to apply for FDA certification, how to register and what are the testing requirements if the medica