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:

FROM

TO

Authorization Requirement: Certificate of Product Registration (CPR)

Authorization Requirement: Certificate of Medical Device Registration (CMDR) or Certificate of Medical Device Notification (CMDN).

Import Clearance Requirement: Clearance for Customs Release (CFCR)

Import Clearance Requirement: Certificate of Medical Device Registration (CMDR) or Certificate of Medical Device Notification (CMDN).

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.

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

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).

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

 

 

References:
FDA Circular No. 2017-013 - Guidelines on the Issuance of Clearance for Customs Release of Radiation Devices by FDA

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