Medical devices and medical consumables need which certification

Domestic: a class and class II need to produce enterprise license and product registration certificate, these certificates are the local Drug Administration. Class III devices for registration is the State Food and Drug Administration. Registration requires quality management system audit approval or Huaguang certification. Medical device GMP certificate is needed from next year.

EU: CE certificate and declaration of conformity are required.

USA: FDA approval certificate or 510K number published on the website.

Certificates similar to China for other countries.

The quality certification standard is ISO13485, but it is usually attached to the certificate of certification. The system certificate alone is not enough, you need a product certification qualification certificate.