Tuesday, December 18, 2012

No Acceptance of Application for Authorization for Medical Devices

December 18, 2012
Calling the attention of all medical device representatives, please be reminded that FDA-Philippines is not accepting application for authorization of Medical Device from December 16, 2012 until January 13, 2013.

Among the applications not accepted are Licence to operate, Certificate of Product Registration, Certificate of Exemption for product & establishment licenses and Amendment of CPR & LTO (including add/delete source).

The Bureau will still receive and process other application such as Application for Automatic Renewal (as specified to FDA memorandum No. 2012-008), Application for Renewal of LTO ( as specified to FDA Memorandum No. 2012-008), Compliance documents for deficiencies both LTO & CPR applications (Tuesday - Friday 8am to 3 pm) and Applications for Certificate of Non-Radiation Emitting (Monday - Friday 8 am to 5 pm). 

Please be guided with the above schedules to avoid non-acceptance of documents/ applications. 

Resource: FDA Memorandum No. 2012-040


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