إجراء مقترح من الفلبين: كواشف تشخيصية أو مخبرية على حامل

The proposed Administrative Order aims to provide guidelines on the conduct of clinical investigation of medical devices and clinical performance study of in-vitro diagnostic medical devices. This Order adopts the relevant provisions of: PNS ISO 14155:2022 entitled 'Clinical investigation of medical devices for human subjects – Good clinical practice'; PNS ISO 20916:2022 entitled 'In-vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice'