Medical device registration before acceptance of technical issues consulting is what

Medical device manufacturers in the preparation of product declarations and technical review of the issuance of compensation process, often have some questions and doubts, hoping to get the review center to answer and guide.

In response to this status quo, the center combined with the actual situation of the technical review work, successively launched the technical review of the consulting and registration of technical issues before the acceptance of consulting services, and the introduction of the "technical review of medical devices consulting management norms", to improve the quality and efficiency of the technical review of medical device registration work, and has played a positive role in promoting. In addition to the center's previous acceptance window on the acceptance of the problem of consulting services, the center's current consulting services are mainly divided into three kinds:

Acceptance window on the acceptance of the problem of consulting, pre-registration acceptance of technical issues consulting and consulting in the technical review.

Scope of Consultation

Communication and Q&A on the acceptance of application materials and formal review of matters related to pre-registration filing.

Purpose of the consultation

To help applicants better understand the domestic application for registration of Class III products, the import of Class II and III products, the continuation of the application, change and filing and other matters related to the requirements to improve the quality and efficiency of registration and reporting work.