With the continuous change of the management system and the opening of policies, more and more inspection institutions have the qualifications and scope of medical device inspection, so how should we choose the right inspection agency as a registrant. I'm going to talk to you about this topic today.
The first thing to tell you is what is a medical device inspection and testing institution
They are a group of institutions that specialize in using a variety of high-tech equipment and professional knowledge to conduct comprehensive, accurate and reliable inspections of medical devices. These inspection and testing work is of great significance to ensure the safety, effectiveness and quality controllability of medical devices, and is an important means to protect the health rights and interests of the people. In order to help these inspection and testing institutions improve their capabilities, the State Drug Administration organized and formulated the "Guiding Principles for the Capacity Building of Medical Device Inspection and Testing Institutions". This guiding principle clarifies the overall requirements, main tasks, and key measures of medical device inspection and testing institutions in terms of capacity building, and provides a clear development direction and specific operational guidelines for medical device inspection and testing institutions.
Why do you need to find a testing agency for medical device registration?
That's because the National Medical Products Administration requires applicants to conduct product registration inspections in order to protect public health and ensure that medical devices are safe and effective. Then, the testing agency has professional technology and equipment to comprehensively and accurately test medical devices. These tests include aspects such as performance, safety, reliability, and more. For example, for devices that require clinical trials, a report issued by a testing institution within half a year must be submitted.
How to find a suitable testing agency for your own products when registering medical devices
First of all, we have to give the inspection agency a "qualification test"!See if they have the "golden signboard" of Article 75 of the Regulations on the Supervision and Administration of Medical Devices. This is a mandatory requirement and cannot be ambiguous!Next, we have to find a "counterpart" testing agency. Don't look for those who don't have the ability to carry out inspections, otherwise your report may be judged to be unqualified, you will have to re-test, and you may even face the risk of being withdrawn!Therefore, you must choose a qualified agency that can undertake inspection!Then, don't forget to submit the inspection according to the technical requirements of the product, and you also have to submit the inspection report. This report can be measured by yourself or commissioned by a qualified agency. In short, make sure that the report is authentic and reliable!So, how do you find the right agency?Don't worry, the Food and Drug Administration has made a list for you, covering 31 medical device inspection agencies at the provincial and municipal levels. Finally, don't take it lightly!Choosing the wrong testing agency can lead to jokes and may even lead to registration failure. Therefore, you must keep your eyes open during the selection process to ensure that the selected institution is reliable and professional!