August 13, 2018

With an aim to strictly adhere to the provisions set by the ASEAN Agreement on Medical Device Directive (AMDD), the PFDA has issued a 3rd draft on the Rules and Regulations for the Registration Application for In-Vitro Diagnostic (IVD) Medical Devices to be placed in the Philippine Market.

The draft includes procedural guidelines on the classification, registration and renewal applications, including the imposition of penalties, grounds of disapproval and administrative sanctions corresponding to any violations of this Administrative Order.

The key points of this regulation are hereby outlined as follows:

PH aug18




Rules and Regulations Governing the Issuance of an Authorization for an In-Vitro Diagnostic (IVD) Medical Device based on the ASEAN Harmonized Technical Requirements