Quality

Wanhe focuses on the construction of the quality management system. Wanhe has successively passed ISO 9001 & ISO 13485 quality system certification in 2002, manufacturing quality management assessment organized by Guangdong Food and Drug Administration in 2009, good manufacturing practice (GMP) inspection organized by Guangdong Food and Drug Administration in 2011 and RDC/61-2000 certification by Brazil National Health Surveillance Agency (ANVISA) in 2012. Wanhe has established a service management system for product R&D, manufacturing, inspection and sale as well as an after-sale surveillance system. The scientific management ensures to provide the customers with the first-class products and service.

 

Wanhe concentrates on the improvement of product quality and the research and development of new products. With a fully equipped manufacturing base, a cleanroom in Class 10000 and 100000, advanced production and inspection devices and apparatus, Wanhe can strictly control the product quality and provide a good environment for product research, development and production. Since the products have been put into market, the market share of Wanhe has grown steadily and the products have gained the recognition of surgeons and patients in Brazil, Colombia, Russia, Taiwan and other countries and regions.

Standard: ISO9001 Number: 04718Q10479R6M Issue Date: 2018-11-12 Expiry Date: 2020-12-30 Scope/Range: Medical apparatus and instruments Issued By: BEIJING HUA GUANG CERTIFICATION OF MEDICALDEVICES CO.,LTD.

Standard: ISO13485 Number: 04718Q10000544 Issue Date: 2018-11-12 Expiry Date: 2020-12-30 Scope/Range: Medical apparatus and instruments Issued By: BEIJING HUA GUANG CERTIFICATION OF MEDICALDEVICES CO.,LTD.

Standard: Production Number: 粤食药监械生产许20010347号 Issue Date: 2020-04-07 Expiry Date: 2025-03-18 Scope/Range: Issued By: CFDA

Standard: CERTIFICATE FOR EXPORTATION OF MEDICAL PRODUCTS Number: 20200520 Expiry Date: 2022-04-29 Scope/Range: Issued By: CFDA