PH Philippinen
  • 11 - Medizintechnik

Medical equipment (ICS 11.040)

Draft Administrative Order No. ____ : Guidelines on the Conduct of Clinical Investigation of Medical Devices for Human Subjects in the Philippines (17 page(s), in English)

The Philippines, as a signatory to the ASEAN Agreement on Medical Device Directive (AMDD), is mandated to institutionalize an appropriate system for the conduct of clinical investigation of medical devices, taking into accout the Helsinki Declaration adopted by 18###sup/sup### World Medical Assembly in Helsinki, Finland, in 1964 and any subsequent amendments or revisions to this Declaration by the World Medical Association.

As the regulatory agency for medical devices in the Philippines and pursuant to the provisions of Republic Act 9711, otherwise known as the "Food and Drug Administration (FDA) Act of 2009", FDA has been tasked to develop policies on the regulation of medical devices to ensure public health and safety from the use of these products. In addition, FDA is also given the power to conduct, supervise, monitor and audit research studies on health and safety issues of health products undertaken by entities duly approved by the FDA. To implement the mandate of FDA and to ensure that all measures relating to the protection of human subjects are carried out during the conduct of clinical investigation of medical devices, this set of guidelines is hereby issued for strict compliance of all concerned.