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Medical Device Registration in the Philippines
Medical device registration in the Philippines is managed by the Center for Device Regulation, Radiation Health and Research (CDRRHR) within the Department of Health. 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. The Administrative Order introduces risk classification of medical devices, as well as new requirements for initial device registration and renewal.
Medical Device Status
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 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. The new review time and registration fees vary by risk categorization:
|Class A Notification (CMDN)
|4 to 12 weeks for authentication
|Class B Registration (CMDR)
|Within 180 days
|Class C Registration (CMDR)
|Within 180 days
|Class D Registration (CMDR)
|Within 180 days
IVDs are not included in this classification. A separate Administrative Order is set to be issued regarding IVDs.
Device Conformity Assessment
New regulations implemented on April 1, 2019 require 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. The new regulations will be implemented in phases:
- Currently all Class A medical devices must have a CMDN, and all Notified (those listed in Circular No. 2021-001-A) Class B, C and D medical devices must have a CMDR.
- All non-Notified (those not listed in Circular No. 2021-001-A) Class B, C and D medical devices must have an initial CMDN in place by April 1, 2024, then upon renewal a more involved CMDR will be required.
- NOTE: Originally, the deadline for non-Notified medical devices was April 1, 2022 but the Philippines FDA has issued an extension to the grace period until 2024. See here for more information.
Home country approval, or reference country approval is required for all classes of devices.
Bordeline Products & Product Confirmation
Manufacturers unsure of their product’s classification and/or product category can request official feedback from the PFDA for a fee of PHP 550.
The PFDA will expect to see the following documents as part of their review:
- Letter of Intent
- Complete Technical Profile of the Product and must include the following:
- Formulation/List of ingredients with corresponding amount per unit dose, expressed in the metric system;
- Directions for use;
- Claims (if any); and
- Labeling materials/Brochure.
- Classification of the product in the country of origin
- List of countries where the product is currently marketed and the corresponding classification of the product in these countries
- Representative sample
- Proof of payment + LRF (₱ 550.00)
Australia – Canada – European Union – Japan – United States
In addition to Home/Reference Country Approval, Notifications and Registrations require technical documentation in accordance with the CSDT Template. Notifications require a device description, Certificate of Conformity, Declaration of Conformity, Declaration of Shelf Life and clear, complete, colored pictures of the labeling. Registrations require additional documentation such as risk assessments and clinical evidence.
Quality Systems Conformity Assessment
Class 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.
Medical device registration in the Philippines is fairly straightforward and efficient.
Expedited Review Options
As 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. This new process aims to shorten the review time to 30 business days. To learn more about this, please see our blog on the topic here.
Exceptions to Home Country Approval Requirement
Medical devices used strictly for research, clinical trial, exhibit and/or donated new are exempt from Notification and Registration. Researchers and institutions using exempt devices must apply for a Certificate of Medical Device Listing.
Validity and Renewal
CMDNs and CMDRs are valid for 5 years, and must be renewed every five years after the initial approval. Renewals can be filed 90 days prior to the expiry of the CMDR or CMDN.
Certificates 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). Certificates of Exemption (COE) issued under the old rules will remain valid until November 3, 2021, or two years after issuance (whichever is shorter). To learn more of License Maintenance in the Philippines, click here.
For CMDN/CMDR transfer projects, Asia Actual will request to review a copy of the existing license and the supporting Foreign Agency Agreement. The transfer application requires the original Registration certificate. Asia Actual will assist to obtain this document from the current holder in the Philippines. However, if the current holder does not cooperate, then a full registration process will be required. The license transfer process typically takes 2 to 3 months to process.
Documents required for the transfer include:
- Letter of Request
- Termination of Contract / Deed of Assignment
- CMDN/CDMR (original)
- Complete Labeling set
- Foreign Agency Agreement
- ISO 13485 certificate
License Holder Requirements
The License Holder must be involved in the customs clearance process for devices for which it holds the Import License. Competitively bid third-party services (e.g., freight forwarding) are charged on a pass-through basis. A Shipment Report is generated per event to record fees and document receipts. The License to Operate of the importer, distributor or manufacturer must be up-dated with the foreign manufacturing source data.
Benefits of Using Asia Actual as Your Independent License Holder
- Sell directly to multiple regional distributors, avoiding mark-up by a national importer
- Increase transfer pricing
- Improve leverage in distributor negotiations/responses
- Add or change distributors as required
- Keep intellectual property away from local commercial agents
- Assure expert handling of post market vigilance and license maintenance
Contact Asia Actual for assistance with your medical device registration in the Philippines or to confirm the cost and time lines that apply to your specific devices of interest. Asia Actual has experienced, bi-lingual consultants in the Philippines to manage the application, importing, and post-market surveillance needs.
Philippines Regulatory Support
Charmaine’s Regulatory Hint
“During this transitory time through 2023, it can be difficult to understand what requirements are currently being applied. We can help.”
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