The design, development, manufacture, processing, packaging, storage, installation method and facility of medical devices for use in clinical trials shall, unless otherwise regulated by regulations of this Chapter, be governed by regulations of Chapter 2 in this Part.

Where manufacturers have not yet established validated manufacturing processes for medical devices for use in clinical trials, or have not yet established comprehensive manufacturing control standards, aforesaid manufacturers shall establish in writing operational procedures and keep detailed and accurate records for each batch of products manufactured and each batch of raw material used. Batch manufacturing records shall be kept until clinical trials are completed, or until at least two years after the product is completed, whichever period is longer.

Where manufacturers provide medical devices for use in clinical trials, aforesaid devices, in addition to conforming to regulations governing labeling in the Act, must also be labeled “for use in clinical trials only”, and marked with the name of the trial sponsor and a trial code sufficient to identify the trial site and research personnel involved.

Manufacturers shall determine suitable expiration dates for medical devices for use in clinical trials based on the product properties, container characteristics and storage conditions; the expiration dates marked on aforesaid devices may not exceed the expiration dates marked on the original product packaging.

Where manufacturers have medical devices for use in clinical trials manufactured or tested on a contract basis, aforesaid contract shall clearly state that the product in question is for use in clinical trials only.

Where manufacturers destroy medical devices for use in clinical trials, destruction of aforesaid devices may not take place until all clinical trials and the final report are completed; detailed records shall be kept of the destruction process, and aforesaid records shall be preserved by the manufacturers.