The Announcement of Principles of Technical Guidance on Clinical Evaluation of Medical Devices by China Food and Drug Administration (No 14, 2015)

Released May, 19, 2015

 1.Purpose

The clinical evaluation of medical devices refers to the validation process through which the applicant of a product registration (referred to as "the Applicant" hereafter) determines whether the product has met the requirements for its use and scope of application by using the information collected from clinical literatures, clinical experience data and clinical trials. The Guidance is intended to provide technical instructions for the Applicant to prepare the clinical evaluation documents and guideline for the administrative departments of China Food and Drug Administration (CFDA) to review the clinical evaluation documents.

2.Regulation basis

2.1.Regulations for the Supervision and Administration of Medical Devices (The State Council Order No. 650)

2.2.Provisions on Medical Device Registration (CFDA Order No. 4)

2.3.The relevant provisions for the quality control of clinical trials of medical devices.

3.Scope

The Guidance applies to the clinical evaluations of Class II and III medical devices for the registration; does not apply to in vitro diagnostic reagents, which are administered as medical devices. In case any new principles of technical guidance on clinical evaluation for specific products are released, the specific requirements of clinical evaluation for the specific products shall be followed.

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