Affected by a variety of factors, medical device business enterprises are facing development difficulties, some of which have shifted their core business to production, and become medical device registrants in the form of commissioned research and development, entrusted registration and entrusted production, and completed the transformation from operation to production.
The journey from operation to production is long and arduous, and enterprises need to receive professional guidance and help in the process of transformation in order to reduce investment and improve efficiency.
Q:becomeMedical devicesRegistration** programWhat are they
Answer: Taking Class II medical devices as an example, the main steps are as follows: Register an enterprise;R&D products;Synchronous commissioned testing, system construction, operation and review, and compilation of application materials after completionSubmit an application for registration;System declaration and assessment;Technical Review;Obtain a product registration certificate. See flowchart for details.
Q:Medical devicesRegistrantDoes a company need a quality manager?
Answer: Yes, at least 1 quality person in charge and 1 management agent are required, and they are on the job.
Q:What information needs to be prepared to apply for a medical device registration certificate?
Answer: There are mainly R&D data, product technical requirements, clinical reports, test reports, etc. Clinical reports are product-specific and not required if they are listed in the exempt list.
Q:How long does it take to apply for a medical device registration certificate?
Answer: It does not include R&D and data preparation time, it takes one to one and a half years from submission to certification for similar products, and about three years for similar products.
Q:No R&D team, productR&D dataWhat to do
Answer: Obtain R&D data authorization and conversion, the conversion period is about 4-6 months. Commissioned research and development, the time depends on the difficulty of the product.
Q:What to do if you don't have the production conditions
Answer: The medical device registrant may entrust an enterprise with production conditions to provide production services. After the product is successfully registered, the registrant enterprise obtains the "Medical Device Registration Certificate" and the manufacturer obtains the "Medical Device Production License".
The above questions and answers are all from real consultation and feedback, and are summarized and provided by Dazihui Great Wisdom - Dazi Pharmaceutical and Biological Industry Incubation Platform, **Please indicate the source!.