Philippines · FDA registration
Medical device registration in the Philippines
Every medical device sold in the Philippines must be notified or registered with the FDA, by risk class, before it reaches the market. We classify the device, prepare the dossier, and handle the CMDN or CMDR through to approval.
Classification
Medical device risk classes
The FDA follows the ASEAN Medical Device Directive, from Class A to Class D, and the class sets which certificate you need.
Class A · low risk
Non-invasive, minimal risk, such as bandages, stethoscopes, and non-digital thermometers. Needs a Certificate of Medical Device Notification (CMDN).
Class B · low to moderate
May be invasive with limited risk, such as blood pressure monitors, suction pumps, and contact lenses. Needs a CMDR.
Class C · moderate to high
Life-sustaining or invasive with higher risk, such as ventilators, infusion pumps, and hemodialysis machines. Needs a CMDR.
Class D · high risk
Sustains or supports life, or is implanted in contact with vital organs, such as defibrillators, heart valves, and pacemakers. Needs a CMDR.
Which certificate
CMDN or CMDR
Notification for the lowest-risk class, full registration for the rest.
| CMDN | CMDR | |
|---|---|---|
| Device class | Class A (low risk) | Class B, C, and D |
| Type | Notification | Registration |
| FDA review | Acknowledges the device’s notification | Full review of safety, efficacy, and quality |
| Dossier | Basic product information | ASEAN CSDT dossier, with risk and clinical data |
Requirements
What a registration needs
The documents every application carries, plus more for the higher-risk classes.
Every application
- Valid License to Operate (LTO)
- Medical device product dossier, in ASEAN CSDT format
- Proof of registration from the country of origin: Certificate of Free Sale or equivalent
- Notarized and apostilled Letter of Authorization from the foreign manufacturer
- ISO 13485 certificate or a quality-system audit report
- Labeling and packaging artwork and inserts
- Product samples and classification confirmation
- Application form and payment of fees
Additional for Class C and D
- Clinical evaluation reports
- Performance testing or biocompatibility reports
- Radiation safety data, where applicable
Foreign manufacturers cannot register directly. A device made abroad is registered by a Philippine-based License Holder, a licensed importer or authorized representative that holds the LTO and carries the obligations after approval. Emerhub acts as the product holder for foreign manufacturers and handles the registration on their behalf, so you can reach the market without setting up a Philippine entity first.
Labeling
Medical device labeling requirements
Labeling follows the ASEAN Medical Device Directive and is reviewed by the FDA as part of the application. Labels have to be in English, or English and Filipino, and carry the details the FDA expects: the product name and code, the registration number from the CMDN or CMDR, the manufacturer and the Marketing Authorization Holder’s name and address, the batch or serial number, the manufacture and expiry dates, the sterility status and method where it applies, and the warnings, storage conditions, and intended use. More complex devices also need instructions for use.
Getting the label right at the registration stage saves rework, since changing it afterwards means amending the certificate.
The process
The registration process
Five stages, starting from the license behind it.
Step 1 — Secure your License to Operate
A CMDN or CMDR sits on a valid LTO, so the license comes first. A foreign manufacturer registers through a local License Holder that holds it.
Step 2 — Classify and compile the dossier
We confirm the device’s class, A to D, and compile the technical documentation, in ASEAN CSDT format for Class B, C, and D.
Step 3 — Submit through the FDA portal
We file the application through the FDA e-portal in the format the device centre requires, so the review is not held up on formatting.
Step 4 — Evaluation and payment
The FDA assesses the application by risk class. We handle its queries and guide you through the fees.
Step 5 — Approval
On approval the FDA issues the CMDN or CMDR, valid for five years, and the device can be imported and sold.
Validity and timelines
How long it takes, and how long it lasts
Both the CMDN and the CMDR are valid for five years, and a renewal can be filed up to 90 days before the certificate expires. Timelines depend on the risk class: a full Class C or D registration can take around 180 days, while a device already approved in another ASEAN country that uses the CSDT, such as Singapore or Malaysia, can qualify for an expedited route aiming at about 30 business days.
In-vitro diagnostics sit under a separate, transitioning regime. Only a defined list of registrable IVDs, such as HIV, hepatitis B and C, and syphilis test kits, currently require registration, often with local testing, and broader IVD rules are expected to follow.
How we help
Emerhub handles the registration
Our FDA team classifies the device, prepares the CSDT dossier, and manages the CMDN or CMDR through to approval, acting as or working alongside your local License Holder. We have handled registrations across all four device classes, and we track the five-year renewal so the certificate does not lapse.
Not sure which class your device falls under, or whether it needs a CMDN or a CMDR? Talk to our FDA team and we will classify it before you file.
Common questions
Medical device registration questions
What device companies entering the Philippines ask most.
Can foreign manufacturers apply for a CMDR directly?
No. A foreign manufacturer registers through a Philippine-based License Holder, a licensed importer or authorized representative that holds the LTO. The manufacturer authorizes it with a notarized, apostilled letter of authorization.
What is the ASEAN CSDT?
The ASEAN Common Submission Dossier Template, the standard format for the technical dossier behind a Class B, C, or D registration. It harmonizes device submissions across ASEAN markets.
What is a Certificate of Free Sale?
Proof from the country of origin that the device is approved and freely sold there. The FDA uses it as evidence of the device’s regulatory standing abroad.
Which devices need a CMDN and which a CMDR?
Class A, the lowest risk, needs a CMDN by notification. Class B, C, and D need a CMDR, which involves a full FDA review of safety, efficacy, and quality.
How long does CMDR approval take?
It varies by class. A full Class C or D registration can run to around 180 days, while devices already approved in another CSDT-using ASEAN market can use an expedited route of about 30 business days.
How long is a CMDR valid?
Five years, the same as a CMDN. Renew within the 90 days before it expires to keep the device on the market without a gap.
Do in-vitro diagnostics need registration?
Some do. A defined list of registrable IVDs requires registration, often with local testing, and the IVD regime is moving toward the same risk-based classification as other medical devices.
On the ground in Manila
Talk to our FDA team
Tell us the device and where it is already approved. Our FDA team in Manila will classify it, prepare the CSDT dossier, and manage the CMDN or CMDR through to approval, acting as or alongside your local License Holder.
Phone+63 928 516 2791
OfficeUnit 710, High Street South Corporate Plaza Tower
2 26th St, Taguig
1634 Metro Manila, Philippines
2 26th St, Taguig
1634 Metro Manila, Philippines