How to classify IVD medical devices
According to applicable laws, IVD medical devices are classified into the following four categories:
Level A - Low personal risk and low public health risk;
Level B - moderate personal risk and/or low public health risk;
Level C - High personal risk and/or moderate public health risk;
Level D - High personal risk and high public health risk.
This guide also provides examples of classifying different IVD medical devices based on the above rules.
Risk level determination
To assist medical device manufacturers in determining the correct category for application, the Administration has provided additional instructions on how to follow classification rules. According to this guide, the steps to be taken include the following:
Determine whether the relevant products constitute in vitro diagnostic medical devices and therefore fall within the scope of IVD classification rules;
Apply classification rules based on the intended use of the device and related risks, and when multiple classification rules are applicable, apply higher level classification rules;
Next Article
RELATED NEWS
Dear Customers & Friends, We sincerely invite you to visit CPHI Shanghai 2025, which will be held at the Shanghai New International Expo Center from June 24th to 26st, 2025. The exhibition is expected to reach a scale of over 230,000 square meters, about 100,000 professional visitors from domestic and abroad, and more than 3,500 participating companies. Company Name: Jinan Enlighten Biotechnology Co., Ltd. Exhibition date: June 24-26 Exhibition address: Shanghai New International Expo Center Our booth: Hall E12 C37 Look forward to meeting you at CPHI Shanghai!
The 22nd CPHI China 2024 was held at the Shanghai New International Expo Center from June 19 to 21, 2024. We had a booth at Hall W7 A55, and our teams from R&D, production, and sales departments participated in this exhibition.
Exhibition Name: CPHI Shanghai 2024 Exhibition date: June 19-21 Exhibition address: Shanghai New International Expo Center Our booth: Hall W7 A55 Look forward to meeting you at CPHI Shanghai!
In order to enhance communication among colleagues and create a passionate, responsible and happy working atmosphere, Jinan Enlighten Biotech organized a team building activity on May 30, 2024 (Thursday) at the Century Park in the southern mountainous area of Jinan.
On April 3, 2024, Mr.Wei, Chairman of Jinan Enlighten Biotech, Mr. Ding, General Manager, and a delegation of six people went to Shanghe to inspect the Health and Pharmaceutical Industry Valley project, laying out the development plan for Wutong group in the next ten years.
Feb 29th to Mar 2nd, Jinan Enlighten Biotech attended Asia Pharma Expo 2024 at Dhaka, which is the largest pharmaceutical machinery and technology exhibition in Bangladesh. The exhibited products included pharmaceutical industry machinery and equipment, APIs, raw materials, pharmaceutical intermediates, excipents and other packaging products. This Expo is an important pharmaceutical information exchange platform in Bangladesh and surrounding regions, attracting suppliers and buyers from all over the world.
SALES MANAGER
Mr.Thomas ：0086-15688864306
E-mail：Thomas@ecechem.com
SALES MANAGER
Ms. Amy：0086-15650581921
E-mail：peilunyun@ecechem.com
SALES MANAGER
Ms. Eileen：0086-15650576753
E-mail：eileen.lee@ecechem.com
Add: B25, Enterprise Mansion, Dongba District, Licheng District, Jinan City, Shandong Province
Follow on WeChat
Copyright : Jinan Enlighten Biotechnology Co., Ltd. Powerby : 300.cn jinan Seo Tags BUSINESS LICENSE
