2021 medical equipment registration inspection instructions
Date：2021-06-25 Views：
First, medical device registration inspection applicable Any of the "Medical Device Registration Management Measures" and its related documents are regulated to our hospital, it is proposed for the inspection application, which is a medical device registration test. Second, medical device registration inspection classification Medical equipment registration inspection classification include: domestic registration, imported registration, registration, and continuation registration. Third, the form that applies for medical device registration test should be filled in Apply for medical device registration tests should be filled in "Inspection Application Form". If the medical device has been approved, it should be filled in the medical device's overseas inspection projects, and the "Application Form of the Medical Device Overseas Testing Project" should also be filled out. Fourth, the information should be submitted by medical device registration inspection Medical instrument registration inspection data consists of the following parts: (1) The test application letter issued by the declaration unit (if necessary, the registration approval for approval documents); (2) Product technical requirements (description of the grass when necessary); (3) If the import registration application is recognized, the original record of self-examination, the original record of the inspection report and the original text of the inspection report. (4) Applicants should also provide: At the same time, the applicant is also approved by the medical device. 1. The original text and Chinese translation of the primary government of the country of origin; 2. Approve the copy of the certificate document; 3. Relevant information (such as the detection record and data analysis of the application for a recognized project), and the official seal or print of the providing unit is stored. The above information must be stated in the official seal of the application unit. It is proposed to comply with the following two situations: 1) In the safety performance indicator or important performance indicators, if a single test has more than 30 days; 2) In an important performance indicator, detection cannot be performed due to the number of samples. 5. Apply for medical device registration inspection requirements for sample requirements Quantity requirements: Under normal circumstances, the number of inspections should be three times the amount of inspection. In special cases such as expensive samples, the inspectors indicate that "no application review" in the "Application Inspection Registration Form" can be reduced as appropriate, but must not be inspected and re-test. Preserving status requirements: Inspection should be packaged, there is a full label, and the content of the label should comply with the relevant documents of the National Bureau's medical device label manual, and there is a quotable label. On the label, you should indicate the name, number or number, model or specifications, production units, production units. The content of the label should be consistent with the application letter (commissioned), and the declaration information is consistent. Sample life requirements: The surplus of the sample generally meets 2 test cycles, except for special circumstances (such as stability test), the sample that has not been met by the prolonged period or validity is not accepted. Sixth, send inspection registration considerations Send samples to check the registration procedures to be detailed, familiar with sample characteristics, understand the information content and registration management requirements, and correctly fill in the inspection application form to be responsible for the content filled. After receiving registration, check the contents of the registration form, confirm that there is no mistake, check or seal, and ask for a receipt and keep it properly, take the report credentials as a query. 7. Preparation number definition and role The number of inspection numbers is the uniqueness identification of the sample after accepting the test application. Inspection acceptance receipts will indicate the printed number, the application unit can query progress on the website (http://www.nifdc.org.cn) based on this number. This number should be provided by receiving the report. Eight, supplementary sample information notice and refund notice The comprehensive business office of the Medium Hospital meets the sample information that meets the requirements, and the inspection department will conduct technical audit on it. If there is a problem impact on the test work, the TCP will issue a "supplemental sample" within 10 days. Data Notice, Technical Review Confirmation Cannot Carry out the test work, the TCP will propose a refund application within 10 days and handle it according to the reflection program. Nine, payment of inspection costs The technical review of the TCU has confirmed that the sample information is in line with the registration inspection work requirements. It will determine the inspection project, and verify the inspection fee item by item based on the national approval, payment the payment unit and contact to the test application form. . The payment unit has been transferred to the Central Financial Bank of the Notice, and the payment certificate is summarized. 10. Test report acquisition pathway After the inspection report of the TCU is issued, the applicant can take the following ways to obtain reports and review opinions. (1) The contact address filled in the Inspection Application Form is mailed to the applicant by the Contact Address of the Trial Application Form. (2) Application units send people to the unit introduction letter and ID card to the General Office of the TCE Institute. (3) Sending samples and accepts receipts and ID cards to the Comprehensive Business Office of the Central Recruitment Institute. When necessary, send a report after the applicant issued a payment certificate. XI, registration test application form and fill in Scan the inspection application form below, or enter the application form for the online check system to enter the inspection system. Application for inspections online, please go to the official registration procedures through the General Office of the Interview Institute after the first test. 12. This "Inspection Notice" According to the current medical device registration management document, when the relevant medical device registration management regulates the registration, I will revise the instructions. This instructions are not appropriate to the upper regulations, and is implemented according to relevant national regulations. More related medical equipment registration, medical equipment certification, US 510K registration, EU medical device CE certification, medical equipment production license, medical equipment business license, etc. Medical equipment consultation, welcome to Beijing Zhong Lijun Mechanic Technology Co., Ltd.!
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