Category: Device Announcements

FDA has released a total of 235 COVID – 19 Test Kits (81 – PCR based, 86 – Rapid Antibody, 58 – Immunoassay and 10 – Others)

As of  today, 17 August 2020, FDA has released a total of 235 COVID – 19 Test Kits (81 – PCR based, 86 – Rapid Antibody, 58 – Immunoassay and 10 – Others)

Click the link below for details.

https://bit.ly/2Zd0CZ4

RRD-CDRRHR ANNOUNCEMENT 03 August 2020

Please be informed that due to COVID-19, the Radiation Regulation Division of the Center for Device Regulation, Radiation Health, and Research – Food and Drug Administration will temporarily shift to online transaction from August 3, 2020 to August 18, 2020 for the following transactions:

  1. License to Operate (LTO)/Certificate of Compliance (COC)/Certificate of Registration (COR) of radiation facilities
  2. Clearance for Customs Release (CFCR) of radiation devices

All official communications and applications regarding radiation facilities are hereby requested to be sent to [email protected].

For your information and guidance.

FDA has released a total of 214 COVID – 19 Test Kits (75 – PCR based, 79 – Rapid Antibody, 53 – Immunoassay and 7 – Others)

As of  today, 30 July 2020, FDA has released a total of 214 COVID – 19 Test Kits (75 – PCR based, 79 – Rapid Antibody, 53 – Immunoassay and 7 – Others)

Click the link below for details.

https://bit.ly/2Zd0CZ4

FDA has released a total of 211 COVID – 19 Test Kits (72 – PCR based, 79 – Rapid Antibody, 55 – Immunoassay and 5 – Others)

To date, FDA has released a total of 211 COVID – 19 Test Kits (72 – PCR based, 79 – Rapid Antibody, 55 – Immunoassay and 5 – Others)

Click the link below for details.

https://bit.ly/2Zd0CZ4

FDA has released a total of 208 COVID – 19 Test Kits (72 – PCR based, 78 – Rapid Antibody, 53 – Immunoassay and 5 – Others)

To date, FDA has released a total of 208 COVID – 19 Test Kits (72 – PCR based, 78 – Rapid Antibody, 53 – Immunoassay and 5 – Others).

Click the link below for details.

https://bit.ly/2Zd0CZ4

FDA has released a total of 178 COVID – 19 Test Kits (60 – PCR based, 69 – Rapid Antibody, 45 – Immunoassay and 4 – Others)

To date, FDA has released a total of 178 COVID – 19 Test Kits (60 – PCR based, 69 – Rapid Antibody, 45 – Immunoassay and 4 – Others)

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

FDA has released a total of 161 COVID – 19 Test Kits (59 – PCR based, 62 – Rapid Antibody, 36 – Immunoassay and 4 – Others)

To date, FDA has released a total of 161 COVID – 19 Test Kits (59 – PCR based, 62 – Rapid Antibody, 36 – Immunoassay and 4 – Others).

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

FDA has released a total of 155 COVID-19 Test Kits (56- PCR based, 60- Rapid Antibody, 36- Immunoassay and 3- Others)

To date, FDA has released a total of 155 COVID-19 Test Kits (56- PCR based, 60- Rapid Antibody, 36- Immunoassay and 3- Others)

Click the link below for details.

https://drive.google.com/drive/folders/1Dk8KjbCzk8g92HydWDRvg8K-ATp7gBez?fbclid=IwAR2v60QZvEV-cV18ft2ZLtvighX6oxCtn3_pWv41fUY2fxjdRo3joNxpXV0

FDA ADMINISTRATIVE ORDER NO. 2018-0002 || Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN HARMONIZED TECHNICAL REQUIREMENTS.

Check this video on how to apply for a CERTIFICATE OF MEDICAL DEVICE NOTIFICATION via FDA Electronic Portal.

/ In Device Announcements / By Administrator / Comments Off on FDA ADMINISTRATIVE ORDER NO. 2018-0002 || Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN HARMONIZED TECHNICAL REQUIREMENTS.

Kapihan at Talakayan Sa FDA For Medical Device Establishments on 28 February 2020

The CDRRHR shall be holding the aforementioned activity on 28 February 2020, Friday, 9:00AM – 12:00PM 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. 2018-0002, 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-served basis. Only one (1) representative shall be allowed per company.

A total of 150 slots shall be made available and confirmation as attendee shall be made via e-mail.

For your information and guidance.

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

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