The timeline for NMPA certification of microscopic devices can be affected by a variety of factors, making it difficult to provide exact figures. The length of the certification cycle usually depends on the nature of the product, the efficiency of the certification body, the speed of the NMPA review, and the issues related to the application documents or matters that need to be further resolved.
In general, the time period for NMPA certification of microscopic devices may include the following main phases:
Preparation Phase: You will need to prepare technical documentation, quality management system documents, clinical trial data (if applicable), and the duration of this phase depends on your preparedness.
Audit and Assessment Phase: The documents you submit will be reviewed and evaluated by the certification body, which can take several months, depending on the efficiency of the certification body.
Validation testing phase: If a product requires validation testing, the timing of this phase depends on the complexity of the test and the time required.
Pre-qualification and issuance of certificates: The NMPA pre-audits the results of the certification body's assessment and issues the certificate if everything meets the requirements. The timing of this stage also depends on the speed of NMPA approval.
Registration phase: You will need to register your product information in the NMPA's device registration system, which usually takes some time.
It is important to note that this is only a general phase, and the specific certification cycle will vary depending on the type of product, changes in regulatory requirements, and the specific situation. Therefore, it is recommended that you communicate with your certification body and NMPA to understand the latest regulatory requirements and certification process before starting certification to more accurately assess the certification cycle.