![]() Competitively bid third-party services (e.g., freight forwarding) are charged on a pass-through basis. The License Holder must be involved in the customs clearance process for devices for which it holds the Import License. Termination of Contract / Deed of Assignment.The license transfer process typically takes 2 to 3 months to process.ĭocuments required for the transfer include: However, if the current holder does not cooperate, then a full registration process will be required. Asia Actual will assist to obtain this document from the current holder in the Philippines. ![]() The transfer application requires the original Registration certificate. License Transferįor CMDN/CMDR transfer projects, Asia Actual will request to review a copy of the existing license and the supporting Foreign Agency Agreement. To learn more of License Maintenance in the Philippines, click here. Certificates of Exemption (COE) issued under the old rules will remain valid until November 3, 2021, or two years after issuance (whichever is shorter). Renewals can be filed 90 days prior to the expiry of the CMDR or CMDN.Ĭertificates of Product Registration (CPR) issued under the old rules will remain valid until expiry, at which point a license renewal application will generate a fresh CMDN, valid for 5 years with a fee of PhP 5,150 (US $110). Validity and RenewalĬMDNs and CMDRs are valid for 5 years, and must be renewed every five years after the initial approval. Researchers and institutions using exempt devices must apply for a Certificate of Medical Device Listing. Medical devices used strictly for research, clinical trial, exhibit and/or donated new are exempt from Notification and Registration. Exceptions to Home Country Approval Requirement To learn more about this, please see our blog on the topic here. This new process aims to shorten the review time to 30 business days. Expedited Review OptionsĪs of September 2022, the Philippines FDA is only providing expedited approval for applications submitted with CSDT documents used for applications submitted and approved in other ASEAN markets. Medical device registration in the Philippines is fairly straightforward and efficient. Quality Systems Conformity AssessmentĬlass A, B, C and D devices all require ISO 13485 or an audit report from the FDA or Japanese PMDA to certify the quality system of the legal and/or actual manufacturing facilities. Registrations require additional documentation such as risk assessments and clinical evidence. Notifications require a device description, Certificate of Conformity, Declaration of Conformity, Declaration of Shelf Life and clear, complete, colored pictures of the labeling. In addition to Home/Reference Country Approval, Notifications and Registrations require technical documentation in accordance with the CSDT Template. Home country approval, or reference country approval is required for all classes of devices. ![]() NOTE: Originally, the deadline for non-Notified medical devices was Apbut the Philippines FDA is expected to issue an extension to the grace period.2021-001-A) Class B, C and D medical devices must have an initial CMDN in place by April 1, 2023, then upon renewal a more involved CMDR will be required. All non-Notified (those not listed in Circular No.2021-001-A) Class B, C and D medical devices must have a CMDR. Currently all Class A medical devices must have a CMDN, and all Notified (those listed in Circular No.The new regulations will be implemented in phases: New regulations implemented on Aprequire risk Class A medical devices obtain a Certificate of Medical Device Notification (CMDN), and risk Class B, C and D medical devices obtain a Certificate of Medical Device Registration (CMDR) to in order to be imported and placed on the market in the Philippines. Please click the following links for more information on classifying and grouping medical devices in the Philippines. A separate Administrative Order is set to be issued regarding IVDs. IVDs are not included in this classification. ![]() The new review time and registration fees vary by risk categorization: The current product classifications are harmonized according to the ASEAN Medical Devices Directive with four classes A, B, C and D ranked from low to high risk categorization. Instruments, machines, in vitro reagents, software and similar or related articles that make therapeutic or medical claims are considered Medical Devices in the Philippines. The Administrative Order introduces risk classification of medical devices, as well as new requirements for initial device registration and renewal. With efforts to harmonize the Philippine Regulatory Guidelines in accordance with the ASEAN Medical Devices Directive, the Philippines Department of Health recently released Administrative Order 2018-0002. Medical device registration in the Philippines is managed by the Center for Device Regulation, Radiation Health and Research (CDRRHR) within the Department of Health.
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