SGS Issues Its First Medical Device Regulation (MDR 2017/745) Certificate in Asia

We are delighted to have issued our first Medical Device Regulation (MDR 2017/745) certificate in Asia to Great Medical Industries (Anhui) Co. Limited.

The China-based company, which manufactures and supplies disposable, sterile and protective medical apparel, gained certification in 8 months when the Chinese market average with Notified Bodies (NBs) is at least 12 months.

SGS Lead Auditor, Sanny Mao, said: "Even though we faced setbacks, such as COVID-19 making scheduling and on-site auditing more difficult, the SGS China team, supported by the global team, persevered to complete the process in record time.

"A huge congratulations to Great Medical Industries, which established a solid quality management system and good technical documentation that supports the quality of their devices. We wish them all the best for the future."

A Great Medical Industries spokesperson added: "We pay great attention to product quality to ensure the reliability of quality control through purchasing, manufacturing, inspection and sales process management.

"During the whole audit period, SGS provided very professional support, working with us throughout the process and to find solutions to any problems found.

"To obtain MDR certification, in recognition of our product quality and system management, is of great significance for our products to enter the EU market.

"We will continue to carry out the legal and regulatory requirements, conscientiously fulfilling the company's responsibilities, and providing users with quality and reliable medical protection products."

Designation and why SGS?

In May 2021, MDR officially replaced the Medical Device Directive (MDD) to enhance safety for European patients through a more robust and transparent framework. This change also brings medical device regulations into line with technical advances, changes in medical science and progress in law-making.

Our Belgian NB was designated a European MDR NB by the European Commission and Belgian Competent Authority (FAMHP) under MDR (EU) 2017/745 in December 2021.

With existing approval under the UK Conformity Assessed (UKCA) scheme, we are one of the few companies that can provide certification services for medical devices across the whole of Europe.

More information on our medical devices services.

To start your MDR CE certification process, fill out our questionnaire.

For further information, please contact:

Virginie Siloret
Global Medical Devices Certification Manager
Knowledge
t: +41 22 739 98 58