ECM Shanghai and ECM Notified Body engaged in a new event for the medical device market in China.

In collaboration with our official Chinese commercial partner ECM Shanghai, on 20 April 2021 we will participate in an important event organised by the China Food and Drug Corporation Quality and Safety Promotion Association (FDSA), a sub-governmental platform that promotes the quality and safety of Chinese manufacturers in various sectors.

ECM has been chosen as a prestigious partner to explain to a large audience of manufacturers the key elements related to the new Medical Device Regulation (EU) 2017/745 (MDR). The aim is to make Chinese manufacturers more aware of the new European compliance requirements of MDR 2017/745.

On 26 May 2021, the new European Medical Device Regulation will become effective and companies who want to introduce their products to the EU market will have to comply with its requirements.

Considering the complexity of the regulatory changes, on 20 April the FDSA organised an entire day dedicated to this topic, with the participation of ECM experts. Thanks to our experience in the field of CE certification of medical devices in accordance with Directive 93/42/EEC and the expertise acquired in the MDR field – for which we are awaiting accreditation – ECM is an important reference point for international stakeholders who wish to acquire more insight into the new regulatory landscape.

ECM Shanghai’s representatives Mr. Antonio Jiang e Mr. Yulong Wu, together with our Technical Managers Eng. Vanessa Biavati and Dr. Tatiana Vignudelli will introduce the main novelties foreseen by MDR 2017/745 and provide companies with guidelines for a better understanding of the regulation. This focus will allow manufacturers to increase their knowledge in order to adapt their processes and products to the requirements requested by the European market.

For information:

ECM Notified Body no.1282 – info@entecerma.it

ECM Shanghai – ecmshanghai@entecerma.cn.it