TBT BSN | Notification

Notification Detail :: G/TBT/N/PHL/186/Add.3

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Administrative Order - The New Documentary Requirements for the Registration of Medical Device Products (19 pages, in English)

Objective

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

11.040 - Medical equipment

Keywords

Human health

Specific Regions

Description

FDA Circular No.2021-002-B  Amendment to FDA Circular No. 2021-002-A entitled “Addendum to FDA Circular No. 2021-002 Re: Full Implementation of Administrative Order No. 2018-0002 entitled “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”” aims to extend the date wherein all the non-registrable Class B, C and D medical devices stated in Section III of this Circular may continue to be manufactured, imported, exported, distributed, transferred, sold or offered for sale without CMDN. Furthermore, this Circular also aims to amend the start period for requiring CMDN or at least with pending CMDN application for the aforementioned medical devices.

Notified Document

1:File here

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.3

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