One-stop registration service for medical device exports welcomes Dongfeng

Since the beginning of this year, the international market has gradually recovered, and the volume of bulk commodity imports has risen. The “One Belt and One Road” and “supply-side reform” policies have jointly exerted power, bringing new orders to many export companies, and even the export of medical devices. Good news. According to relevant data, in the first half of the year, the export value of medical equipment was US$ 10.208 billion, which was a year-on-year increase of 3.15% and the export structure was further optimized. Correspondingly, the export of medical devices has also led to the development of the registered market, and one-stop registration services have become the “sweet spot” in the eyes of the company.

At present, foreign trade, foreign aid, international exhibitions, international industrial cooperation, and foreign government procurement are all good opportunities for corporate products to appear on the international stage. However, because medical device products are rather special, exports to the European Union, the United States, Japan, South Korea, Brazil, Australia, and other countries still need to meet the standards of these countries, and the access standards vary among countries, such as the export of medical device products to the European Union. Representatives authorized by the EU, and according to the different types of products, the process is also different, and exports to the United States will require FDA registration, exports to Australia require TGA registration and so on.

Obviously, it is better for exporting companies to arrange for specialized staff to deal with these registration matters than for professional medical device registration companies. For example, Shanghai Gebiao Enterprise Management Consulting Co., Ltd. is a certification consulting and service organization with independent legal personality. The majority of companies provide professional one-stop medical device registration certification services.

Since its establishment seven years ago, the company has been adhering to the development philosophy of “professionalism first, service first, honesty and trustworthiness” and is dedicated to serving customers. For each customer, the company's senior team will be based on the needs of customers, and after detailed understanding of product information, carefully develop a professional and comprehensive solution for medical device registration certification. If there is a problem in the middle, the team will do their best for the customer. For example, during the FDA registration of Class II products, the preparation and rectification of the 510(k) document often makes some customers feel intractable. The team will provide customers with powerful assistance to help the customer's products to successfully complete the registration.

Today, the company has accumulated a wealth of medical equipment registration, certification consulting and testing consulting strength and project experience, respectively in the United Kingdom, the United States, Germany opened a branch. The business covers CE for medical devices, EU registration for medical devices, and FDA for medical devices.