PFDA released FDA Circular No. 2017-013-A as an amendment document to harmonize with the DOH Administrative Order (AO) No. 2018-0002 and to provide guidelines for medical radiation devices through FDA Circular No. 2021-002.
The summary of FDA Circular No. 2017-013-A is as follows:
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Authorization Requirement: Certificate of Product Registration (CPR) |
Authorization Requirement: Certificate of Medical Device Registration (CMDR) or Certificate of Medical Device Notification (CMDN). |
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Import Clearance Requirement: Clearance for Customs Release (CFCR) |
Import Clearance Requirement: Certificate of Medical Device Registration (CMDR) or Certificate of Medical Device Notification (CMDN). |
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RF Coils for MRI, ultrasound probes or transducers, x-ray tubes (other parts or device accessories used for replacement of x-ray tube) will require CFCR |
Accessories and software that are intended by the manufacturer to be used in combination with a medical radiation device for its intended purpose are required to have CMDN or CMDR. |
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Devices listed in FDA Memorandum Circular No. 2014-005 and amendments will require CPR.
For Devices not listed in the document, they will require a Certificate of Exemption (COE) |
Revoked |
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Medical Radiation Devices and Accessories intended for research, clinical studies, clinical investigations, exhibits, private use of health institutions, sample product for analysis/testing with ongoing CPR application or donated brand new products will require Certificate of Medical Device Listing (CMDL). |
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Medical Radiation Devices and Accessories that are part of foreign donations to the health sector shall follow DOH AO No. 2020-001. |
All other provisions of FC No.2017-013 not affected by these changes shall remain valid and in effect