What information is required for the filing of a class of medical device products?
The first class of medical devices manufacturers to normal production and operation, you need to apply for the following documents:
A first class of medical device product registration filing;
0. A copy of the business license copy, a copy of the organization code certificate;
1. Product risk analysis information-safety risk analysis report
2. Technical requirements
3. Product compliance with the list of national industry standards
4. Product test report Jining
5. Clinical evaluation information ball seek
6. Product manuals and labels 154
8 production and manufacturing information 963
9 Clinical evaluation information 2616
Two, the first class of medical devices Production for the record;
1 business license, organization code copy
2 legal person ID card
3 production, quality management personnel education certificate
4 production management, quality inspection positions, employees, education, title list
5 plant lease contract and supporting documents
6 main production equipment and testing devices
7 medical device quality management and program documents
All of the above have, in order to produce and operate.
How to check the production record of Class I medical devices?
1, open the browser, enter the location of the enterprise's government service center, submit a pre-approval of the application to generate a pre-acceptance number.
2, the applicant needs to submit paper application materials to the window.
3, the relevant departments will be reviewed after acceptance, acceptance of the conditions, do not meet the return, incomplete materials to tell the applicant one-time corrective materials.
4, will be handed over to the higher authorities for approval, to be filed for the production of certificates, issued by the first class of medical devices production record vouchers, inadmissible issued by the notice of non-adoption.
5, the applicant in the window to get the first class medical device production record certificate or not through the decision letter
What is the composition of a class of medical devices record certificate?
The first class medical device record vouchers include: "Class I Medical Device Record Voucher" and "Class I Medical Device Manufacturing Record Voucher"
The "Class I Medical Device Record Voucher" is the product's proof of approval, equivalent to the product's ID card, with this voucher, the product also has the legal qualification of registration.
"Class I medical device production record certificate" is the product is allowed to produce the approval of the certificate, equivalent to the enterprise production license, if there is no such certificate, the enterprise can not produce the product.
What is the validity period of the Class I Filing Information Form?
The validity period of the Class I medical device registration certificate is the same as that of the medical device registration certificate, which is valid for 5 years.
The filing of Class I medical device refers to the handling of Class I medical device product certificates in accordance with the relevant requirements of the Regulations for the Supervision and Administration of Medical Devices, which is equivalent to the product's ID card for marking the product's name, use, description, expiration date, etc., as well as the manufacturer, commissioned by the manufacturer, etc., to prove that the product has been filed by the drug supervision and management authorities and has the force of law.
Filing refers to the registrant to submit the product filing materials, make relevant commitments, and the filing of the authenticity of the materials, integrity and compliance is responsible for; market supervision and management department shall file the filing materials submitted by the filer to meet the requirements of the form of examination for the record.
A class of devices for the record inquiry?
The first class of medical devices product filing information publicity
2021 (01)
According to the "Supervision and Administration of Medical Devices Regulations", "Measures for the Administration of Registration of Medical Devices" (the former State Food and Drug Administration Decree No. 4) and the former State Food and Drug Administration, "on the filing of Class I medical devices on the matters of the Announcement" (Announcement No. 26). (Announcement No.) of the provisions and procedures, the Bureau of Yunnan Hai Feng Pharmaceutical Co., Ltd. class I medical device product record materials for formal review, meet the relevant filing requirements, to be filed, the record information is hereby made public.