Wow! A Chinese IVD company obtained CE certification within 10 days, there must be some experts behind this achievement!

On January 3, 2022, the European Commission issued a new announcement agency (Notified Bodies, NB) granting it the status of an NB organization (NB 2934) authorized to issue CE certificates under the IVDD regulations. The newly approved agency is from Poland and is called CeCert Sp. z o.o.

According to investigations, this agency received ISO:13485 certification in 2020 and was authorized by the Ministry of Health to become a designated announcement agency in October 2021.

The IVDD will expire on May 26, 2022, and manufacturers must complete technical documents and product registrations before this date in order to enjoy the transitional policy and continue to sell their products in the European market.

As the implementation of the IVDR regulations in May 2022 approaches, many manufacturers want to obtain CE certification according to the IVDD classification rules before the new EU regulations take effect, in order to seize business opportunities and sell in the European market. This is a forward-looking choice for IVD manufacturers with a keen sense of smell.

However, the current 19 qualified NB agencies are far from meeting the current market demand. Many manufacturers who want to apply for CE certification are waiting for announcement agencies to accept their applications. This makes the approval of CeCert even more important as it is the only currently accepting NB agency.Therefore, the approval of CeCert as a new announcement agency is a scarce new resource in the market, and it has quickly gained the favor of manufacturers.

With the implementation of the new regulations approaching, the time window for obtaining CE certification according to the IVDD classification is getting shorter, and many manufacturers are taking action. The number of cases that announcement agencies can handle and accept is very limited, so manufacturers who are still hesitating need to act quickly. This agency can still issue CE certificates under IVDD for in vitro diagnostic products before May 2022. This scarce new resource is in high demand, and the last opportunity to join the bandwagon should not be missed.

CE1434 self-testing certification is a certificate that needs to be issued after a third-party announcement agency (NB) recognized by the EU conducts strict technical review and testing of the manufacturer's medical equipment products to prove that the product is safe and has reliable clinical performance, and meets international technical specifications. CE1434 is recognized as a difficult certification with a long cycle and strict requirements, and it is a test and judgment of the manufacturer's overall strength. The CE certificate is highly valuable.

The Pure Global team has already helped multiple clients in the industry successfully obtain CE 1434 certificates. Recently, the Pure Global team has received good news that two clients' new coronavirus antigen self-testing products have obtained the CE 1434 certificate: congratulations to Boditech (Xiamen) Biotechnology Co., Ltd. and Chongqing Zhongyuan Huiji Biotechnology Co., Ltd.! These successful cases fully demonstrate the professional strength and efficient speed of the Pure Global team in the CE application process.

It is worth noting that both cases were completed in accordance with the latest MDCG2021-21 EU clinical new regulations.

Pure Global , a professional one-stop service provider

In order to obtain CE certification before the new regulations are implemented, it also tests the team's professionalism and clinical capabilities. Not all teams have the ability to complete the entire process and obtain the certificate in such a short time.

Pure Global has regulatory and clinical experts from multiple countries worldwide, and a chief expert team whose mother tongue is English can provide comprehensive support for customers' technical document writing. At the same time, we also have local clinical medical post-doctors in China, academic experts in immunology and cell biology, who can provide local technical support for customers' IVD products and communicate without barriers. We truly help domestic manufacturers achieve the level of technical document writing in Europe and the communication and service support in China; relying on the technical resources and clinical capabilities of the global team as a strong backing, we can truly escort your business.

The European market is changing rapidly. The Pure Global team has an in-depth understanding of the regulatory policies of various European countries, and can help customers seek the best solutions with professional knowledge and first-class response speed, and quickly enter overseas markets. The Pure Global team will continue to provide high-quality and efficient full-process services at the fastest speed, and catch up with the last five months of the opportunity to jump on the bandwagon.

Tip:Pure Global has launched the world's first COVID-19 antigen whitelist query website (free of charge)

Currently, the international COVID-19 pandemic situation is still severe, and the demand for COVID-19 detection reagents in the international market is strong, making COVID-19 antigen detection products a new favorite for export. In order to help domestic IVD manufacturers and global distributors connect resources, the Pure Global team has specially launched a whitelist query website for Chinese manufacturers of COVID-19 antigen detection products, which helps you easily query Chinese companies listed on the COVID-19 antigen whitelist in major markets and countries around the world such as the United States, the European Union, the United Kingdom, France, Germany, Australia, Canada, Spain, Portugal, Switzerland, and the Czech Republic. All information comes from the official regulatory agencies of various countries. This whitelist website will continue to update the global certification status of Chinese companies and their COVID-19 detection products!