Second Category Medical Device Registration Covery Review Technical Service System (Trial)
Second Category Medical Device Registration Covery Review Technical Service System (Trial)
1. This system is applicable to the application for the registration of the second type of medical device product, and the declaration of the product is "exempt from the Clinical Trial Medical Device Product Catalog", or provides clinical evaluation information with the same variety comparison, there are national standards, Industry standards or guiding principles and other related standards, while the product has applied for medical device registration test.
2. When the registration, the applicant applies for registration inspection, it can also submit the application for the second type of medical device product registration volume to the Henan Food and Drug Review Center (hereinafter referred to as "Center") website, and will mail the declaration information To the central integrated business department 520 room.
3. Covered Review Technical Service Declaration Information includes: Register Applicant According to No. 43 of 2014, submit product registration data (except for registration inspection report), two copies; "second type medical device registration volume review technical service application A table.
4. The relevant requirements of the documentation review of technical service work procedures and working hours and the Measures for the Administration of Medical Devices. The Center reviews the declaration of the report, and it is necessary to correct the information that needs to be corrected. The applicant submits the correction information (two copies), and the center reviews the correction materials and proposes the review. The operation of the technical service, in line with the requirements of the technical review, and returned the applicant's declaration information, and the center is returned; the applicant is not compliant with the requirements of the technical review, all materials and review opinions.
5. After the registration inspection, the applicant has received the registration inspection report, and the application information and review of the authorities of the establishment of the technical service, submitted to the Henan drug supervision government service hall, and entered the registration review process. After receiving the formally submitted product registration data, the center has reviewed the information and related products of the registration inspection report, and the association is reviewed within 30 working days, and the review will be issued.
6. If there is a serious difference in the reporting information of the inspection report and the documentary review technology service, it has caused a deviation of the review of the review of the technical service of the volume, affecting the conclusions of product registration technology review, and work procedures. Medical Device Registration Management Measures, No longer performing article 5.
7. If the product registration data submitted by the acceptance department is inconsistent with the declaration information of the standby examination technology service, there is a major difference, affecting the conclusions of the product registration technology, no longer executes Article 5, and no longer accepts within one year. The applicant's arid review technical service application is applied.
8. Adhere to the voluntary principles, the applicant can choose whether or not to perform a volume review technology service. If you enter the volume review technology service procedure, before the end of the volume review technology service, select the direct access to the product registration process, and the technical service work is automatically terminated. Applicants will change the declaration plan in the process of waiting for the registration inspection report, and can submit the withdrawal application to the center integrated business section, withdraw the documentary review technical service application and the application materials. Annex 2 Second Category Medical Device Registration Roll Review Technical Service Application Form Product Name Classification Code Model specifications Structural composition Scope of application Clinical evaluation Method £ is "Free Contents" Products Catalog for Clinical Test Medical Devices £ same variety alignment Applicable standard product technical requirements Medical equipment inspection agency inspection acceptance number Volume review Technical Services Applicant enterprise name Production address Legal representative * Entrusted agent * * Contact Address (from the postal delivery notice) Applicant committed
1. Our unit voluntarily applies for the second type of medical device product registration volume review technology service.
2. Our unit declared product belongs to the product in the Catalog of Clinical Test Medical Devices. £ Our unit declared product adopts the same variety alignment to provide clinical evaluation information. £
3. Our unit declared products with national / industry standards / product registration technology review guidelines, and the application of the product has been referenced in the product technical requirements of the product. The declared product has been applied for medical instrument registration test and accepts it.
4. My unit has carefully read the requirements in the "Second Category Medical Device Registration Currency Review Technical Service System (Trial)", and agree to the implementation. Other questions that need to be explained: Sub-legal representative (signature) declaration unit (signature) Year, month, month Note: Plus "*" item is used for mailing fees, and must be confirmed. If the contact error cannot be mailed, the responsibility is borne by the applicant.
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