Risk Classification of Medical Devices
Your device’s risk classification determines the documentation and timeline required for FDA registration in the Philippines.
Class A: Low Risk
Devices that are non-invasive with minimal risk, such as bandages, stethoscopes, and non-digital thermometers. Requires a Certificate of Medical Device Notification (CMDN).
Class B: Low to Moderate Risk
Devices in this category may be invasive but with limited risk, and include blood pressure monitors, suction pumps and contact lenses. Requires a Certificate of Medical Device Registration (CMDR).
Class C: Moderate to High Risk
These devices may be used in sustaining life or be invasive, with a higher potential risk. It includes devices like ventilators, infusion pumps, and hemodialysis machines. Requires a Certificate of Medical Device Registration (CMDR).
Class D: High Risk
These are devices often used to sustain or support life, prevent impairment, or implantable devices that are in direct contact with vital organs. It includes defibrillators, heart valves, and implantable pacemakers.
CMDN vs CMDR: Which Certification Do You Need?
The type of FDA registration and certification you require will depend on your medical device’s risk classification.
| Feature | Certificate of Medical Device Notification (CMDN) | Certificate of Medical Device Registration (CMDR) |
|---|---|---|
| Applicable Device Class | Class A (Low Risk) | Class B, C, and D (Low-Moderate to High Risk) |
| Process Type | Notification | Registration |
| Purpose | Serves as an official acknowledgement of the device’s notification to the FDA. | Requires a full review by the FDA to ensure product safety, efficacy, and quality. |
Key Requirements for Medical Device Registration in the Philippines
- Valid License to Operate (LTO)
- Medical Device Product Dossier (CSDT Format)
- Proof of Registration from Country of Origin: Certificate of Free Sale (CFS) or equivalent, and foreign regulatory approval.
- Notarized and Apostilled Authorization Documents: Letter of Authorization (LOA) from the foreign manufacturer.
- Labeling and Packaging Information: Label artwork and packaging inserts, which must include product name, intended use, batch number, expiration date, etc.
- Product Samples
- Product Classification Confirmation
- Duly Accomplished Application Form
- Payment of Application Fees
- Additional Documentation for High Risk Devices (Class C and D): Includes clinical evaluation reports (CER), performance testing or biocompatibility reports, and radiation safety data (if applicable)
Medical Device Registration Steps with Emerhub
1
Secure a License to Operate (LTO)
Before registering your medical device, you must first obtain a valid FDA LTO. Our team will assist with completing the LTO registration process efficiently, ensuring all documentary and legal requirements are in place.
2
Medical Device Classification and Document Compilation
Your medical device must be classified according to the FDA guidelines. We will identify the correct classification and compile all the technical documentation as required, including product dossiers, certifications, and labeling requirements.
3
Application Submission via the FDA Portal
Once the documents are ready, we will submit your CMDR application through the FDA’s e-Portal. Our experts will ensure your application adheres to the proper formatting as required by the FDA for a smooth review process.
4
FDA Evaluation and Payment
The FDA will assess your application based on risk classification, and we will coordinate with their personnel to ensure all questions and concerns are addressed accordingly. After the evaluation, we will guide you through the payment process through your preferred payment gateway.
5
CMDR Approval From the FDA
Upon approval, a Certificate of Medical Device Registration will be issued by the FDA. We will notify you immediately and provide any post-approval guidance to ensure that your product is prepared for market entry. The CMDR will be valid for 5 years and needs to be renewed at least 90 days before its expiration date.
Have questions or need more information?
Why Choose Emerhub For Your CMDR in the Philippines?
A reliable FDA partner is key to successful medical device registration. With Emerhub, you get a trusted partner that handles the complexities for you.
Experienced in Medical Device Compliance
We’ve successfully handled registrations across all device classifications (Class A to D) for 14 years, ensuring your product meets FDA requirements from start to finish.
Efficient Process Handling
From classification to dossier preparation and submission, we streamline every step to minimize delays and avoid issues with the FDA, saving your time and resources.
Professional Regulatory Team
Our consultants stay updated with the latest FDA regulations and ASEAN harmonization rules, so your devices align with evolving standards to avoid costly rework or delays.
FAQs on FDA Philippines Medical Device Registration
No, foreign manufacturers cannot apply for a CMDR directly. Only local Philippine companies with an LTO can act as the legal license holder or distributor for CMDR applications. Foreign companies must appoint a licensed local representative or distributor like Emerhub to handle the registration and compliance process.
It is the Common Submission Dossier Template that is required by the FDA for CMDR applications. It includes product description, risk assessment, test data, labeling, etc.
A Certificate of Free Sale is evidence that the medical device is approved, legally circulated, and freely sold in its country of origin, issued by that country’s competent authority. It is commonly required in export markets to prove both regulatory approval and market presence in the exporting manufacturer’s home country.
Approval timelines for the CMDR vary, but typically take around 6 to 12 months, depending on the device classification, complexity of the medical device, and completeness of documents.
Variants may sometimes be grouped under a single CMDR, but this depends on specific FDA rules and on whether the variants share essential similarities like intended use, risk classification, manufacturing process, etc.
Often, products with different variants will require separate registrations and certifications with the FDA. Exact requirements are determined on a case-by-case basis by the authorities.
If your CMDR expires, you must immediately cease importation and distribution of the affected product in the Philippines. Only after the CMDR is renewed or newly issued may these activities resume.
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Liz Servañez
Liz Servañez serves as Branch Manager in the Philippines.
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Christine Aguilar
Christine Aguilar serves as Head of Operations in the Philippines.
Start Your CMDR Process with Emerhub Today
Get clarity on CMDR requirements, classifications, and timelines. Schedule a call with us, and our experts will guide you through every step.
Email Us
philippines@emerhub.com
Call Us
+63 945 726 2635
Visit Us
35th Floor Penthouse, Ecotower, 32nd Street, 9th Ave, Taguig, 1800 Metro Manila, Philippines