This page covers the regulatory authority, device classification, registration process, local representative requirements and FAQs for medical device registration in the Philippines. Medical devices in the Philippines are regulated by the Center for Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (FDA Philippines), and EVERBIZ can support you through the entire process from classification to registration.
1. Regulatory Framework
Medical devices in the Philippines are regulated by the Center for Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (FDA Philippines).
Core regulations:
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Administrative Order No. 2018-0002 – the main medical device regulatory framework, introducing risk-based classification
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FDA Circular No. 2020-001 / 001-A – classification list and list of registrable devices
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FDA Circular No. 2021-002 – transition guidance for ASEAN harmonized requirements
The classification rules are aligned with the ASEAN AMDD, submissions use the CSDT template, and all documents must be in English.
2. Risk Classification and License Types
The Philippines uses four risk classes, mapped to two types of certificates:
| Class | Risk | Certificate type |
|---|---|---|
| Class A | Low | CMDN (Certificate of Medical Device Notification) |
| Class B | Low–moderate | CMDR (Certificate of Medical Device Registration) |
| Class C | Moderate–high | CMDR (Certificate of Medical Device Registration) |
| Class D | High | CMDR (Certificate of Medical Device Registration) |
These certificates – CMDN/CMDR/CPR – are collectively the product marketing authorization.
3. Prerequisites for Registration
1. License to Operate (LTO): The local entity must first obtain an LTO as a medical device manufacturer or distributor (MDDC) – including importers, exporters and wholesalers. The LTO is applied for via the FDA e-services system and is a mandatory prerequisite for product registration.
2. Local Authorized Representative (LAR): Foreign manufacturers must appoint a local Philippine entity holding a valid LTO as authorized representative, responsible for submissions, compliance and vigilance.
3. Non-exclusive distribution allows multiple registrations: The Philippines allows the same product to be registered separately by several LTO holders under non-exclusive agreements, in contrast to Indonesia’s “single License Holder” policy, making it easier for manufacturers to manage multiple distribution channels.
4. Registration Process
Step 1 — Obtain an LTO: The local entity applies for and obtains an MDDC LTO via FDA e-services.
Step 2 — Product classification and grouping: Determine the class under Circular 2020-001 / 001-A; the FDA performs a pre-assessment before application to confirm classification and grouping.
Step 3 — Prepare the application documents
General documents:
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CSDT technical dossier (required for CMDR; CMDN only needs basic product information)
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ISO 13485 certificate – mandatory for all Class A/B/C/D; FDA or PMDA audit reports are also accepted
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Letter of Authorization (LOA) – imported devices must include a notarized declaration by the manufacturer or product owner in the country of origin confirming the authorization
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CFS (Certificate of Free Sale) – authenticated by the Philippine consulate
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Regulatory approval in the country of origin / reference country (US FDA, CE, PMDA, etc.)
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Risk analysis report
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Labeling and IFU – English or Filipino
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Distribution agreement between the importer and the manufacturer
Step 4 — Submit via the FDA e-Portal
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Class A → e-Notification portal
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Class B/C/D → CMDR submission channel
Step 5 — FDA CDRRHR review: Complete dossiers proceed to evaluation. If there are deficiencies, there is a single 90-calendar-day period to respond; failure to comply leads to disapproval, and the applicant may reapply within 60 days.
Step 6 — Obtain the CMDN / CMDR
5. Fast Track: ASEAN Abridged Pathway
Class B/C/D devices approved by another ASEAN member state’s NRA can follow the abridged pathway –
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Leveraging assessments already completed in the region to avoid duplicate review
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Significantly shortening time to market
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A concrete example of the Philippines’ recognition of ASEAN regional regulatory harmonization
Strategic value: Singapore HSA approval is the most commonly used basis for this pathway. Products already registered in Singapore can enter the Philippines much faster.
6. Registration Timelines and Validity
| Item | Time |
|---|---|
| CMDN (Class A) | Relatively fast, usually 1–3 months |
| CMDR (Class B/C/D) | 6–9 months; up to 9–12 months including deficiency responses |
| Renewal | 3–6 months |
Validity:
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CMDN / CMDR: 5 years
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Renewal applications must be submitted within 90 days before expiry
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Some categories (such as certain transitional CMDNs) may be valid for 1 or 2 years (non-renewable; must be converted to CMDR)
7. Key Compliance Requirements
Labeling (English or Filipino, including):
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CMDN / CMDR registration number
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Names and addresses of the manufacturer and the license holder (importer/distributor)
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Lot / serial number
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Manufacturing and expiry dates
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Sterility status and method
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Warnings, contraindications and special storage conditions
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Intended use (diagnostic or radiation devices must state the nature and intensity)
IVDs and local testing:
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Some IVDs (e.g. pregnancy test kits, COVID-19 tests, HIV tests) must undergo performance evaluation testing at a National Reference Laboratory (NRL)
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Testing fees are paid separately
8. Post-Market Obligations
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Adverse event reporting and FSCA notifications
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Variation notifications – changes to product name, packaging, labeling, accessories, address, etc.
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Transfer of the certificate holder is treated as a variation – provided the original agreement has been terminated, a new agreement signed and the original certificate is in hand
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Subject to routine or random FDA inspections
9. Key Transition Milestones (Timeline)
| Time | Event |
|---|---|
| January 2018 | AO 2018-0002 issued, introducing the risk-based classification framework |
| 7 February 2020 | Circular 2020-001 takes effect; four-tier classification formally implemented |
| 2021 | Circular 2021-002 issued, launching the full transition from “non-registrable” devices to CMDN/CMDR |
| April 2022 | Certificates of Exemption (COE) expire; imports may continue as long as a CMDN application has been filed |
| April 2023 | FDA stops accepting CMDN applications for formerly “non-registrable” Class B/C/D devices; first renewals must convert to CMDR |
| April 2024 | Full transition completed; all Class B/C/D devices must hold a CMDR |
| May 2025 | FDA suspends certain registration fees for new medical devices |
| July 2025 | FDA appoints a new Director General |
| October 2025 | Notification list updated |
10. Recent Developments
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Electronic IFU (eIFU) rules – advanced across ASEAN in 2025; the Philippines has issued related guidance
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Strengthened post-market surveillance – greater PMS coordination across ASEAN
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Registration fee suspension (May 2025) – benefits certain categories
Strategic Value and Challenges
Opportunities:
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A market of about 110 million people in ASEAN with steadily growing healthcare demand
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Multiple registrations allowed – parallel registration through several channels under non-exclusive distribution, more flexible than Indonesia
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The ASEAN abridged pathway recognizes approvals by regional NRAs, and Singapore HSA registration can serve as a basis for acceleration
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The common CSDT template lowers the cost of reuse across the region
Challenges:
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Relatively long review times (CMDR 6–12 months)
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The 90-day deficiency period is a one-time opportunity; missing it means reapplying
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LOAs require notarization + consular authentication, making document preparation time-consuming
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Some IVDs require mandatory local NRL performance testing
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Long regulatory transition – the status of existing CMDN/CMDR certificates needs to be reviewed to avoid gaps
How EVERBIZ Can Help
EVERBIZ has offices in Shanghai, Hong Kong, Germany, Austria, Singapore, Malaysia, Thailand and Vietnam. For the Philippines market, we offer:
- Product classification and registration pathway planning
- Preparation and review of CSDT technical documentation
- Local authorized representative / registration holder arrangements
- Submission, responses to deficiency letters and progress tracking
- Post-market compliance maintenance (changes, renewals, adverse event reporting)
Contact us for a Philippines medical device registration plan and quote, or see our registration services for other countries and regions.
Philippines Medical Device Registration FAQs
Which authority regulates medical devices in the Philippines?
The Center for Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (FDA Philippines).
What types of medical device registration exist in the Philippines?
Class A devices require a Certificate of Medical Device Notification (CMDN), while Class B, C and D devices require a Certificate of Medical Device Registration (CMDR).
Do foreign manufacturers need a local company?
Yes. Applications must be submitted by a local Philippine importer or distributor holding an FDA License to Operate (LTO).
How long is a Philippine medical device registration valid?
CMDN / CMDR certificates are generally valid for 5 years, and renewal applications must be submitted within 90 days before expiry.