Draft Guidelines on the Labeling Requirements for Medical Devices in the Philippines

Title of document
Draft Administrative Order No. ___ : Guidelines on the Labeling Requirements for Medical Devices in the Philippines (10 page(s), in English)

Description
The Food and Drug Administration (FDA) through the Center for Device Regulation, Radiation Health and Research (CDRRHR) is the primary agency authorized to enforce regulatory requirement on manufacture, importation, distribution, sale, and offering for sale of medical devices in accordance with the provisions of Republic Act 9711 also known as FDA Act of 2009, its Implementing Rules and Regulations (IRR). As stipulated in the IRR, the CDRRHR is mandated to establish an effective regulatory system and mechanism to ensure the safety, quality and performance of medical devices in the Philippines.

Notifying member: Philippines

Notification: G/TBT/N/PHL/215

Objective tag
Consumer information, labelling

Objective
This Administrative Order aims to provide guidelines on the labeling requirements for medical devices aligned with the provisions of the ASEAN Medical Device Directive.

Documents

• 19_1879_00_e.pdf

Agency responsible
Department of Health - Food and Drug Administration

Timing:

• Submission: 02/04/2019
• Reception: 02/04/2019
• Distribution: 03/04/2019
• Final date for comments: 02/06/2019
• Proposed date of adoption: N/A