CMDN Application Process: Notification Steps for Class A Devices and Common Rejection Reasons

1. Key takeaways

The CMDN (Certificate of Medical Device Notification) is the notification route that the Food and Drug Administration of the Philippines issues for Class A medical devices. The order of work is fixed: confirm that the licence holder has a valid LTO, verify the risk classification of the product, prepare the notification dossier, file it through the eServices portal, complete the system initial evaluation and obtain the Order of Payment, then pay so that the application is accepted and the certificate is released. Since 10 March 2025 every Class A CMDN has to be filed through the eServices portal. The practical cycle is about 1 to 3 months.

• CMDN is the notification route for Class A devices; Class B, C and D products follow the CMDR route instead, and filing a higher-class device as Class A leads to immediate return of the application.
• The dossier rests on five groups of material: device description, declaration of conformity, shelf-life statement, reference country evidence and colour label images. Each group has its own formal requirements.
• Colour label images are the single most frequent reason for a returned notification: black-and-white copies, screenshots, incomplete labels, Chinese characters or text too small to read are all rejected.
• The certificate is valid for 5 years and renewal has to be filed within 90 days before expiry; an expiry ledger should be opened on the day the certificate is issued.
• Because the notification route skips technical review, teams tend to treat it as a formality. The returns we see are almost never technical problems; they are document consistency problems.

2. Legal basis

The route is created by Department of Health Administrative Order No. 2018-0002 of 26 January 2018, which defines the CMDN in Section IV, item 4, and assigns it to Class A devices. The submission channel was moved to the eServices portal by FDA Advisory No. 2025-0189, which took effect for Class A notifications on 10 March 2025. Validity and renewal follow the 5-year term and the 90-day pre-expiry window applied under AO No. 50 s. 2001 during the current moratorium. The fee is settled against the Order of Payment generated by the portal, so the payment slip is also the evidence that the application has entered the queue.

3. Expert insights

The CMDN list is shorter than the CMDR list, but short does not mean loose. The notification concentrates on five groups of material: device description, declaration of conformity, shelf-life statement, reference country evidence and colour label images. Every one of them has a formal requirement attached. Reference country evidence means proof that the product is already lawfully marketed in the country of origin or in a reference market, for example a CFS. Colour label images must be clear, complete and in colour; a black-and-white photocopy or a screenshot does not qualify. That single point accounts for a large share of returned notifications, and it is entirely avoidable.

Returns cluster into four categories. Across Class A files handled by GRZAN, the recurring reasons are consistent. First, non-compliant label images: not in colour, missing elements, containing Chinese characters, or printed so small that the text cannot be read. Second, an LTO problem: the holder licence has expired, or the activities it lists do not cover device import and distribution. Third, product names that do not match: the name and model differ across the LOA, the CFS, the label and the application form. Fourth, a broken authorisation chain: the LOA is not notarised, the Apostille is missing, or the document has already expired.

None of these four is a technical difficulty. They are all failures of document consistency management. A single four-way name comparison table, maintained from the start of the project through to submission, removes most of the exposure. The discipline is unglamorous but it is what separates a clean notification from a cycle of returns, and it costs far less than a reworked file.

The costliest Class A mistake is choosing the wrong pathway. If a product actually belongs in Class B, C or D but is notified as Class A, the application is returned outright. A related trap deserves equal attention: CMDN applications for Class B, C or D devices that are not on the list of registrable devices have not been accepted since 1 October 2024, because the grace period under FC No. 2024-003 expired on 30 September 2024. This is one of the most frequent errors found in Chinese-language material during verification.

A CMDN also needs a five-year expiry ledger. Work after issuance is routinely neglected. The certificate runs for 5 years, renewal has to be filed within 90 days before expiry, and late filing is handled through a penalty. With the post-market obligations of AO No. 2025-0030 in place, a Class A holder also has to run vigilance and record-keeping processes. Being exempt from technical review is not the same as being exempt from post-market responsibility.

4. Practical recommendations

• Write a classification decision memo before preparing any material. Record the rule and the item number applied and the reasoning behind the conclusion, so that the pathway choice can be defended if it is questioned at the counter.
• Build a four-way name comparison table. Check the product name and model word by word across the LOA, the CFS, the label and the application form, and keep the table under version control until the certificate is issued.
• Approve a compliant label proof before printing. Use colour photographs of the physical label or high-resolution colour scans, and confirm the absence of Chinese characters and the presence of every mandatory element.
• Verify the LTO before filing. Check four items: licence number, expiry date, activity type and the name of the qualified person. A licence that does not cover device import and distribution invalidates the whole filing.
• File only through the eServices portal and keep the Order of Payment. The payment slip ties the submission to a date and a fee reference, which is useful when the file has to be traced later.

5. Verification checklist

• □ Product is genuinely Class A under the AMDD classification rules.
• □ Product is not an IVD and not a refurbished device (AO No. 2018-0002, Section III).
• □ Holder LTO is valid and its activities match import and distribution.
• □ Colour label images are complete, legible, free of Chinese characters and carry all mandatory elements.
• □ Product name and model are identical in all four documents.
• □ LOA is notarised and Apostilled, with the original available and an online verification record.
• □ Submission was made through the eServices portal at eservices.fda.gov.ph.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including the Philippines. Our team prepares CMDN/CMDR dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the FDA Philippines, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com