Law Summary
Objectives of the Circular
- Streamline the CFCR issuance process to ensure clear identification, traceability, and inventory control of radiation devices.
- Guarantee proper distribution and accountability from importer to end-user.
Applicability and Coverage
- Applies to all importers of radiation devices for medical and non-medical use entering the country.
- Non-emitting radiation devices or devices not listed are exempt from CFCR requirements.
Key Definitions
- Bureau of Customs (BOC): Governs import/export enforcement.
- CDRRHR: FDA division regulating radiation-emitting devices.
- CFCR: Document authorizing Customs release.
- Certificate of Product Registration (CPR): Certification issued for approved devices.
- Device: Includes medical devices and radiation devices.
- Medical device: Intended for diagnosis, prevention, monitoring, treatment without pharmacological means.
- Radiation device: Electrical/electronic apparatus emitting ionizing/non-ionizing radiation.
- Device Accessories: Supplementary parts not emitting radiation.
- Importer: Person or entity importing devices.
- Non-emitting radiation devices: Devices incapable of producing radiation.
Application and Submission Requirements
- Submission of a written request to CDRRHR Director with detailed device and importer info.
- Requirements include number of units, intended use, importer/supplier info, installation site, notarized letter for buyer info submission, and safety certification.
- Medical devices require a CPR or equivalent safety certificate authenticated by Philippine Consulate; temporary notarized letter submission allowed.
- Non-medical devices require safety certification or international standard documentation.
- Additional required documents: brochure, importer’s local government permit, proforma invoice.
Evaluation and Issuance Procedure
- CDRRHR evaluates submission within three (3) working days to confirm radiation-emitting status.
- If confirmed, CFCR is required before customs release.
- Specific enumerated radiation devices for medical and non-medical use require CFCR (e.g., CT scanners, X-ray machines, laser devices).
- Some device accessories (e.g., RF coils, ultrasound probes, X-ray tubes) must have CFCR; others (e.g., cassettes, printers, software) are exempt.
Fees and Payment
- A non-refundable fee of ₱300.00 per device is payable to FDA prior to CFCR processing as per Administrative Order No. 50 s. 2001.
Processing Time
- CFCR application must be processed within three (3) working days post payment.
Repealing Clause
- Revokes B.O. No. 020 s. 2007 and all other inconsistent rules to harmonize regulations.
Separability Clause
- Invalidity of any provision does not affect the remaining provisions of the Circular.
Effectivity
- Circular is effective immediately upon recording and publication.