Legal Analysis: Medical Device FDA Certification Time Cycle:
Class 1 Medical FDA Registration Cycle: within 1 week
Class 2 Medical Device FDA Registration: about 6 months
Class 3 Medical Device FDA Registration: 10 to 12 months
The agency conducts a self-registration FDA approval process that can take anywhere from one week to eight months of time, depending on whether it is self-registered, submits a 510(k) application or submits a pre-market approval (PMA) application.Bringing a medical device to market is not a quick process, with studies showing that it takes a total of three to seven years to go from conception to approval***, compared to an average of 12 years for drugs.
The most effective way to speed to market is to assess the level of risk associated with a medical device and determine whether it is a Class 1, 2 or 3 device.There are three pathways to market acceptance:
1. Self-registration
2. 510(k) Submission
3. Pre-market Approval
The three-step process:
1. Paying the registration fee.
2. Electronic submission of listing and registration information.
3. Receive an acceptance e-mail from the FDA.
Legal basis: "Measures for the Administration of Medical Device Registration" Article 32 The Food and Drug Administration receives the application for formal review of the declaration information, and according to the following circumstances, respectively, to deal with: (a) the application belongs to the terms of reference of the department, the declaration of information is complete, in line with the requirements of the form of review, to be accepted;
(b) the declaration of information that can be corrected on the spot, the applicant shall be allowed to Correction of errors, the applicant should be allowed to correct on the spot;
(C) the declaration is incomplete or does not meet the formal review requirements, the applicant should be informed of all the contents of the need to make corrections within five working days at a time, the late notification, from the date of receipt of the declaration information is admissible;
(D) the application does not fall within the purview of the department, the applicant should be informed of immediate The applicant is inadmissible.
Food and Drug Administration acceptance or inadmissibility of applications for registration of medical devices, should be issued with the special seal of the department and the date of acceptance or inadmissibility of the notice.