SUNGO provides customers with a complete 510(k) Band-Aids
Band-Aids are medical devices designed for dealing with trauma and small wounds. Ordinary Band-Aids are subject to only general controls for entry into the U.S. market and do not require premarket notification. Antimicrobial Band-Aids, on the other hand,
SUNGO coached an enterprise in Ningbo on the FDA 510K project for manual wheelchairs and the range include preparation of technical documentation and product testing services
It is worth mentioning that the full set of tests of the company is carried out by SUNGO lab, which fully meets the requirements of the FDA and covers all points and areas of FDA concern.
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
The FDA has again increased various fees for Fiscal Year 2024
The FDA has again increased various fees for Fiscal Year 2024，Annual Establishment Registration Fee is $7,653，Premarket Notification Submission Fee is $21760($5,440 for small enterprises).The FDA recently released its fees for FY 2024Various FDA fees in F
SUNGO constantly strives to provide Chinese enterprises with custom-made device compliance services in line with international standards.
With the transition period of Swiss medical devices regulations officially ending on July 31,2022, all medical devices are currently required to be individually designated as a Swiss representative (CH-REP) when exported to Switzerland. As a professional
SUNGO Propels Global Cosmetics Compliance Services
China now has the world's second largest cosmetics market and the fastest growing cosmetics industry of any major economy in the world.According to statistics, China's cosmetics market showed rapid growth from 2017 to 2021 due to the country's economic de
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