a、What is the change of medical device registration and license?
According to the "Administrative Measures for Registration of Medical Device" (Order No. 4 of the General Administration of Food and Drug Administration) Chapter 6 and "Regulations for Registration and Approval of Registration and Approval of Imported Medical Device in China" [2014] No. 208)，"Medical Device Registration Certificate" and the content listed in its attachments are registered limited Stake Sports Bettingcontent，Registered second category、The third category of medical equipment，Medical Device Registration Certificate and the contents stated by its attachments changes，The registor shall apply to the original registered department for registration and change。
Registration changes are divided into registered matters and changes in license matters。
The registered person name and residence in the registration certificate、The name of the agent and the change of the residence，The registrant shall apply to the original registered department for registration.，The registrant shall apply for a change in registration after the corresponding production permit change。
and the product name of the registered certificate and its attachments、Model、Specification、Structure and composition、Applicable range、Product technical requirements、The production address of imported medical device and the corresponding content in the "other content" columns, etc.，The registrant shall apply to the original registration department for a license to change。
For the content that has not changed in the registration certificate and its attachments,，Enterprises shall do a good job of related work in accordance with their own quality management system，and ensure the stake betting appcontinuous and effective operation of its quality management system。

2、Can the changes and licenses of medical device registration be applied at the same time?
According to the "Announcement on the Registration of Medical Devices (Including External Diagnostic Reagents) for Medical Device (Internal Diagnostic Reagents)" (Announcement on the Corporation of the General Administration "，Changes of registered matters and changes in permitted matters can be applied separately，You can also merge the application。
Merge application，The applicant shall fill in the "Application Form for Changes in Medical Device/In vitro Diagnostic Reaging Reagents" and "Application Form for Changes in Medical Device/External Diagnostic Reagent Registration License"，and change the merger registration items/license items in the "other issues that need to be explained"。Different registration applications of the same product use the same information (including proof files and technical information)，Only one piece of information can be provided with any registration application for application，In other applications, the original source of the application information must be indicated。
After April 1, 2015，​​The above matters can still apply at the same time，Announcement on the "Announcement on Registration Reported stake betting appon Medical Device (Including External Diagnostic Reagents)" (No. 129) Requirements at the same time。Related applications shall be handled according to the procedure of changing the application in the license item。

Three, what is approved medical device?
A registered medical equipment，refers to the medical device that is consistent with the registration certificate and attachment limited content of the medical device and produced at the validity period of the medical device registration certificate。
　
4. What does the relevant notarization requirements mean?
According to the "Specifications for the Third Category and Imported Medical Device Registration Approval" (Food and Drug Administration [2014] No. 208)，Imported product declaration information，If there is no special explanation，The original information should be signed by the applicant。The original information "sign" refers to: Signature of the applicant's legal representative or person in charge，or signature and stamped with the organization's seal，and shall be submitted to the notarized document issued by the notary agency where the applicant is located。
Its notarization is mainly for the "signature" for the original information，to ensure that the application for the registration of imported products and the information it provided，My stake betting appIndeed is the applicant's own true wishes，The related behavior is true。