Philippines | Hierarchy of Product Standards for Medical Devices to be Complied with for Notification/Registration Purposes | FDA Circular No. 2021-001

Title of document
FDA Circular No. 2021-001 Hierarchy of Product Standards for Medical Devices to be Complied with for Notification/Registration Purposes (2 page(s), in English)

Description
This Administrative Order was formulated to guide the local manufacturer, importer and/or distributor of medical devices regarding the product standards to conform prior to notification/registration with the Philippines' Food and Drug Administration as part of the implementation of Administrative Order No. 2018-0002: Guidelines Governing the Issuance of an Authorization for a Medical Device Based on the ASEAN Harmonized Technical Requirements.

Notifying member: Philippines

Notification: G/TBT/N/PHL/252

Objective tag
Protection of human health or safety

Documents

• FDA-Circular-No.2021-001.pdf

Agency responsible
FOOD AND DRUG ADMINISTRATION PHILIPPINES DEPARTMENT OF HEALTH

Timing:

• Submission: 07/05/2021
• Reception: 07/05/2021
• Distribution: 07/05/2021
• Final date for comments: N/A
• Proposed date of adoption: N/A