Category: Device Announcements

SUSPENSION OF TRANSACTIONS OF RADIATION REGULATION DIVISION (RRD) ON DECEMBER 9-11 2019

Due to the Scheduled Operational Planning and Performance Review of the Radiation Regulation Division (RRD) Of The Center for Device Regulation, Radiation Health, And Research, Food and Drug Administration On Dec. 9-11, 2019, There Will Be No Transaction for The Submission of Application for The Following Authorizations:

  1. License to Operate an X-Ray Facility
  2. Certificate of Compliance for Hospital Based X-Ray Facilities
  3. Radiofrequency Radiation (RFR) Safety Evaluation Report for RFR Facilities
  4. Clearance for Customs Release (CFCR) For Radiation Emitting Devices

Applicants Are Encouraged to Submit Their Application Before December 9, 2019.

Thank You.

Attachment:-> SUSPENSION OF TRANSACTIONS OF (RRD) ON DECEMBER 9-11 2019

KAPIHAN AT TALAKAYAN SA FDA FOR MEDICAL DEVICE ESTABLISHMENTS

MEMORANDUM

The CDRRHR shall be holding the aforementioned activity on 19 September 2019,Thursday, 9:OOAM – 12:OOPM at the FDA Lobby.

The Kapihan at Talakayan aims to provide a venue for the discussion, clarification and/or suggestion on the implementation of Administrative Order No. 2018-002, Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements.

All interested parties may signify their attendance thru registration by e-mail at [email protected] Registration shall be on a first-come, first-serve base and one (I) representative shall be allowed per company.

A total of 100 slots shall be made available and confirmation as an attendee shall be made via e-mail.

For your information and guidance.

Attachment-> : KAPIHAN AT TALAKAYAN SA FDA FOR MEDICAL DEVICE ESTABLISHMENTS

8th ASEAN Medical Device Committee Meeting and its Related Activities on 4-8 August 2019

The Center for Device Regulation, Radiation Health and Research (CDRRHR) will be hosting the 8th ASEAN Medical Device Committee Meeting and its Related Activities on 4-8 August 2019 at the Shangri-la Hotel, Makati City under FPO No. 2019-0442.

There will be NO TRANSACTION for any medical device applications on the said dates.

However, letters and compliance documents shall be received by FDAC.

All transactions will resume on 12 August 2019.

For important concerns, please email us at [email protected]

For your guidance.

Attachment-> : 8th ASEAN Medical Device Committee Meeting and its Related Activities on 4-8 August 2019