The inspection and quarantine is done by the State Administration of Inspection, not Customs, time or according to do the project and the number of fixed
Medical device inspection center What are?Guangdong, Beijing, Jiangsu and other places have specialized medical device inspection ah
Medical device inspection to test what certificates, titlesMedical device inspection certificate, title:
1. medical device inspector
2. "medical device internal auditor certificate"
3. If you want to take the academic certificate: biomedical engineering / instrumentation / electronic engineering and other specialties. Electronic engineering and other specialties.
Medical device product testing methodsThe applicant or the filer should prepare to register or record the product technical requirements of medical devices. Class I medical device product technical requirements by the filer for the record when submitted to the Food and Drug Administration. Class II, Class III medical device product technical requirements by the food and drug supervision and management department in the approval of the registration to be approved.
The product technical requirements mainly include the performance indicators and test methods of finished medical devices, of which the performance indicators refer to the functionality of the finished product can be objectively determined, safety indicators and other indicators related to quality control.
Medical devices marketed in China should comply with the technical requirements of the products approved or filed by the registration.
Article 16 The application for registration of Class II and Class III medical devices shall be registered test. Medical device testing organizations should be based on product technical requirements for the registration of the product inspection.
The production of registration test samples should be in line with the relevant requirements of the quality management system of medical devices, registration test qualified before clinical trials or apply for registration.
For the first class of medical devices for the record, the filer can submit the product self-test report.
Article XVII of the application for registration test, the applicant shall provide the inspection agency for the registration test of the relevant technical information required, the registration test with samples and product technical requirements.
Article 18 The medical device testing organization shall have a medical device testing qualifications, within the scope of its inspection and testing, and the applicant to submit the product technical requirements for pre-evaluation. Pre-evaluation of opinions with the registration of test reports issued to the applicant.
Not yet included in the scope of medical device testing organizations to undertake inspection of medical devices, by the corresponding registration and approval departments to designate the ability of the inspection agency to carry out the test.
Article XIX of the same registration unit should be able to test the product on behalf of the registration unit within the safety and effectiveness of other products.
The purpose of the medical device registration inspection?
According to the "Administrative Measures for the Registration of Medical Devices" Article IX: Class II, Class III medical devices by the State Food and Drug Administration in conjunction with the State General Administration of Quality Supervision, Inspection and Quarantine recognized medical device testing organizations to carry out the registration test, the test meets the applicable product standards before being used in clinical trials or apply for registration.
Simply put, the test you want to register the product is not in line with the relevant national, industry and corporate standards, only the test meets the standard of the product is eligible to apply for registration.
How to do inspection medical equipment business
According to your company to determine, some companies need to go out and run the business, while some companies are telemarketing and conference marketing, so it depends on the company's marketing model
Medical equipment inspection of the factory work well
From the factory's actual public installations, process conditions, according to the standard or inspection protocols inspection, should not be difficult to do. It should not be difficult to do.
How long does it take to do a clinical trial of a Class II medical device
The time is needed to evaluate the product, generally simple without the need to pass the ethical meeting, it is only two or three months of time.
What file on medical devices in the type inspection requirements? How often?
Product standards, generally require at least once a year
How long does it take to certify a medical device product?This depends on what you want to certify that aspect of the la, a year, slow a few years there, you want to look for certification, you can look at the Ao Zi Da medical device consulting company, very professional. I hope to help you.