With the wide spread of COVID-19, we are all worried about this pandemic and we are also paying more attention to the safety of medical devices during this special time. Many medical device manufacturers have worked overtime to expand the production capacity, which has made a great contribution for preventing and controlling the virus spreading.
TÜV SÜD China is a subsidiary of TÜV SÜD Product Service GmbH, a Notified Body for medical device and a Certification Body for EN ISO 13485 in EU. Medical Health Service of TÜV SÜD China gives the following notices:
TÜV SÜD Product Service GmbH has never issued a CE certificate for non-sterile surgical masks, non-sterile surgical gowns, disposable isolation garments for medical use or SARS-COV-2 test kits and reagents used by professional operators. According to the MDD 93/42/EEC and IVDD 98/79/EC, conformities of these devices are required to be declared only by manufacturers themselves. Manufacturers should be compliant with these directives, establish quality management system, maintain CE technical documentations, issue Declaration of Conformity and register the products at competent authorities in EU, etc.
Recently, some companies have fabricated EN ISO 13485 or CE certificates or revised valid certificates based on the certificate issued from TÜV SÜD Product Service GmbH. These are all illegal actions. Once a spurious certificate is found, we will immediately report to the Chinese authority and Notified Body in EU. The original valid certificates may be suspended or withdrawn. Furthermore, those companies may hold liability and be blacklisted.
Dear Customers, please report to local competent authority and inform us via telephone +8621 61410765 if your certificate was forged by distributers, agents or other entities.
We will continuously make further efforts in auditing manufacturers of COVID-19 related medical devices, actions including but not limited to product sampling inspection, unannounced audit, CE documents sampling review and special onsite audit.
Dear Customers, COVID-19 pandemic is spreading in most countries and territories of the world. In this hard time, we encourage all manufacturers to be responsible and place safe and effective products into market. We hope that “made-in-China” medical devices can earn a worldwide reassuring reputation by taking social responsibilities.
If you would like to check our certificates, please visit:
Medical Heath Service
TÜV SÜD Certification and Testing (China) Co., Ltd.