Sterile medical masks produced by Harbin Pharmaceutical Group General Pharm Factory – a unit of Harbin Pharmaceutical Group Holding Co – recently obtained crucial European Union quality recognition.

It was strategically important for the group’s export ambitions.

The company received what is known as EC attestation of conformity, from the agency TuV Rheinland Greater China, which is based on the EU Medical Device Regulations, or MDR.

TuV Rheinland is an international independent third-party testing, inspection and certification organization. 

The recognition is the first of its type issued by TuV Rheinland in China, making the company the first medical mask manufacturer in the country to comply with the latest EU MDR regulations and pass the certification in an on-site audit.

The manufacturer is a high-tech enterprise involving pharmaceutical R&D, production and sales, which is headquartered in Harbin.

It only took 10 days for the factory to achieve full production of the masks, meeting surging demand in the wake of the novel coronavirus outbreak.

The factory’s daily output has soared from an initial 600 to 250,000.

The European certification indicates that the factory’s mask products have reached the continent’s market requirements and standards, laying a solid foundation to enter the EU market and providing a quality benchmark for product sales in domestic and international markets.