Changzhou Major Medical obtaining EU-MDR certification

Changzhou Major Medical Products Co.,Ltd. (hereinafter referred to as “Major Medical”) recently declared that MDR (Medical Device Regulation) on Class I, Is and IIb had been obtained with certificate No. G10 0775360014 Rev.00；No. G21 0775360015 Rev.00. MDR certification is one of the most recent medical device regulation in EU; it replaced the previous medical device directive (MDD); it aims to ensure all the medical devices entered EU markets reach a higher safety performance and effectiveness standard. Obtaining MDR certification means that the products of Major Medical meet strict supervision requirement and can be legally sold in EU markets with stronger international competitiveness.  

The MDR that Major Medical obtained covers four EMDN codes. Please refer to below the product scope list that MDR certificate covers.

·M04040301- HYDROCOLLOID DRESSINGS

·M04040701 - SILICONE DRESSINGS

·M040101 - ADHESIVE DRESSINGS

·M040102 - FIXING DRESSINGS

This is an important milestone for Changzhou Major Medical and proves the continuous efforts and excellent achievements the company makes on product quality management and technological innovation aspects. This important achievement marks that the product quality and safety performance of Major Medical in medical device field has reached the highest international standard and paves the way for our products to enter European markets and other high standard global markets.

Major Medical has been committed to providing high quality medical device since its establishment; we constantly strengthen our technological research and development capability and actively promote the internationalized process of our products. The obtaining of MDR certification affirms that Major Medical sticks to quality first and innovation driven development strategy in the long run. 

(No.G10 0775360014 Rev.00)	(No.G21 0775360015 Rev.00)