TBT BSN | Notification

Notification Detail :: G/TBT/N/PHL/186/Add.2

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

“Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”

Objective

Harmonization (TBT)

Product Covered

This Administrative Order applies to all medical devices to be sold, imported, exported, manufactured, and used in the Philippines, except in-vitro diagnostic and refurbished medical devices, for both of which separate Administrative Orders shall be issued.

Document Notification

Link to ePing

HSCODE

ICSCODE

Keywords

Specific Regions

Description

These guidelines shall cover Class B, C and D medical devices that are not included in the list of registrable medical devices in FDA Circular No. 2020-001 as amended by FDA Circular No. 2020-001-A. The Circular provides for specific timelines for relevant stakeholders to follow for Certificate of Medical Device Notification (CMDN) and Certificate of Medical Device Registration for Class B, C and D.

Notified Document

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/PHL/186/Add.2

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