Home    CFDA Registration   AQSIQ Register   CIQ Inspection   CNCA Registration   NHFPC(MOH) Register   MOA Register      Contact Us


Requisite data of Medical Device SFDA Re-Registration

(1) Application form.
(2) legal Qualification certification for medical device manufacturing enterprise.
(3) Copy of old registration certificate.
(4) Document proving that the government in the country of origin has approved the  product to be sold as medical device in the market of that country or region.
(5) Product technical specifictions which refer to the requirements for safety and technical functions of the product to be registered and the corresponding testing methods  (two copies required for Class III products).
(6) Product instruction for use.
(7) Type test report issued within 1 year before the registration application by a test center  recognized by the State Food and Drug Administration.(applicable to Class II and  Class III products).
(8) Product quality tracking report.
(9) Product Quality Guarantee issued by the manufacturer certifying that the quality of the  product to be registered for sale in China is exactly the same as that of the product marketed in the country (region) of origin.
(10) Letter of Authorization for designated agency.
(11) Letter of Authorization for designated after-sale service agency.
(12) Letter of Authorization for registration.
(13) Letter of Authorization for standard.
(14) Accord with national technology.
(15) Statement of quality responsibility.
(16) Truth and accuracy statement.กก 
        Similar topics:


 

Similar Topics
 Top Articles
 Latest Articles
  Search Tools
China National GB Standards Search
China HS Code Search
Customs Tariff & Tax Search
CIQ Import Inspection Requirements Search
China Cosmetics Formula Ingredients Analysis Systemกก
China Foods Formula Ingredients Analysis System
Contact Us
Post Message
[email protected]กก
rjschina
+86-400-6578191
กก
  |  Home  |  About Us  |  Our Service   |   China Regulations News  |  Contact Us  |

+86-400-6578191        [email protected] 
106# Zhongmao Mansion,No.1 Beizhan Road, Shenzhen,China 518000
©  RJS Copyright  2001-2020 All Rights Reserved



www.GBstandards.org