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Philippines Medical Device Registration
Medical device product 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:
|Classification Type||Risk Level||Review Time||Application Fee||Evaluation Fee||Annual Retention Fee|
|Class A Notification (CMDN)||Low||4 to 12 weeks for authentification||PhP 7,500||PhP 750||PhP 5,150|
|Class B Registration (CMDR)||Low-moderate||Within 180 days||PhP 7,500||PhP 750||PhP 5,150|
|Class C Registration (CMDR)||Moderate-high||Within 180 days||PhP 7,500||PhP 750||PhP 5,150|
|Class D Registration (CMDR)||High||Within 180 days||PhP 7,500||PhP 750||PhP 5,150|
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 Class A, B, C and D medical devices to attain a Certificate of Medical Device Notification (CMDN) in order to be imported and placed on the market in the Philippines. The new regulations will be implemented in three phases:
- All Class B, C, and D devices will be required to obtain a CMDN.
- Will require Class D devices to meet Certificate of Product Registration (CMDR) standards.
- All Class B and C devices will be required to obtain a CMDR.
The Notification Number or Registration Number will be issued to the device with an approved CMDN or CMDR.
Home country approval, or reference country approval is required for all classes of devices.
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 ISOs or an audit report from the FDA or Japanese PMDA to certify the quality system of the legal and/or actual manufacturing facilities.
Registration in the Philippines is fairly straightforward and efficient.
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).
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.
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 13486 certificate
Benefits of Independent License Holding through Asia Actual
- 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, top level consultants in the Philippines to manage the application process.
Philippines Regulatory Support
Charmaine’s Regulatory Hint
“While the new medical device regulations are transitioning, it can be difficult to understand what requirements apply when. We can help.”
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Latest Market Updates
- The Philippines FDA Issues Guidance for Retailers of Medical DevicesOctober 15, 2021 - 11:27 am
- The Philippines FDA Releases List of VAT Exempt Therapeutic ProductsSeptember 22, 2021 - 9:57 am
- Philippines Releases New Guidance on Class A Medical DevicesAugust 24, 2021 - 10:23 am
- Philippines Extends Grace Period for Non-Notified Class B, C, and D Medical Device RegistrationAugust 18, 2021 - 2:05 pm
- Philippines Announces New PEMDL Essential Medical Device ListJune 30, 2021 - 3:17 pm