Registration of Class II Import Medical Device

Docs required for registration of Class II/III import medical device:

(1) The certificate of the legal production qualification of the Manufacturer.

(2) The qualification certificate of the applicant

(3) The certificate recognized or approved by the government of the Country (Region) of Origin to authorize the products as medical devices to enter into the market of the country.

(4) The Standards of the Products to be Registered shall apply the Provisions for the Management of the Medical Devices Standards

(5) Operation Manual of the Products

(6) The Type test Report presented by the medical devices quality test agency recognized by the State Drug Administration within the recent one year 

(7) The clinical trial report of medical devices

(8) The Product Quality Guaranty presented by the Manufacturer, to promise that the quality of the products registered and sold in China are unanimously the same as that of the identical products put into market in the Country (Region) of Origin.

(9) The certificate of commission for the After-Sale Service Agency designated in China, the letter of commitment and business certificate of the commissioned agency.

(10) The Self-Guarantee Declaration on the authenticity of the materials submitted.