Philippines Essential Principles Checklist and Declaration of Conformity

1. Key takeaways

Yes, they are required. The Philippine CSDT file contains two related elements: the Essential Principles Checklist, which requires compliance with each applicable AMDD essential principle to be argued item by item, and the Declaration of Conformity, which is the formal statement issued by the product owner. Class A devices filed through the CMDN route must also submit a Declaration of Conformity.

GRZAN note: the checklist is the one module that touches almost every other module in the dossier, because each entry has to cite evidence that lives somewhere else in the file. It should therefore be written last and read first: written last so that every citation points to a document that already exists, and read first by reviewers who use it as a map of the whole submission. The module can be remembered as 2 documents, 4 elements per argument, and 1 rule that no principle is ever left blank.

• Essential Principles Checklist covering every applicable principle of the AMDD;
• Declaration of Conformity signed by the product owner;
• Declaration of Shelf Life stating the basis for the claimed shelf life;
• The same Declaration of Conformity obligation applies to Class A devices under the CMDN route.

The reason the checklist attracts so much reviewer attention is that it is the only place where the dossier states, in one sequence, what the device is claimed to satisfy and on what basis. A strong checklist shortens review because the reviewer can follow the citations outward; a weak one lengthens review because every claim has to be reconstructed from the underlying reports.

2. Legal basis

The obligation, its parent framework and the associated declarations are summarised below. The Philippine order does not invent the principles; it operationalises a regional framework, and the technical content of those principles traces back to the GHTF work that the ASEAN framework itself drew on. That lineage matters in practice, because it explains why the same supporting evidence can often serve several markets at once. It also explains why the checklist is familiar terrain for reviewers trained on the regional framework, and why unexplained deviations from that pattern attract attention.

3. Expert insights

Insight 1: the checklist is an argument chain, not a tick-box table. The most common error is to turn the checklist into a column of ticks. The correct form is a four-part argument: the applicable principle, then the specific method by which this product satisfies it — standard number, test method and result — and then the conclusion drawn from that evidence. For principles that do not apply, the entry must state the reason, for example that a non-sterile device is not subject to the principles governing sterilisation, rather than being left empty. The four parts also make each entry independently auditable: a reader can accept or challenge the method without having to ask what the claim was meant to prove.

Insight 2: an argument must point to verifiable evidence, not to adjectives. A statement that the product is safe and reliable carries no weight in review. An effective entry reads as follows: biological evaluation was completed in accordance with ISO 10993-1, the cytotoxicity, sensitisation and irritation tests all met the limits set by the standard, and the report carries a specific number. What the reviewer needs is a traceable evidence number, not an assurance. The distinction is not stylistic; an adjective cannot be checked, and anything that cannot be checked cannot support a conclusion in a technical review.

Insight 3: the checklist is the module where one change moves everything. Its entries cite the risk management report, verification reports, clinical evidence, labelling and almost every other module. The workable drafting order is therefore to complete the other technical modules first and compile the checklist last, so that each argument points to an evidence number that is already in place. The reverse order produces a checklist full of empty references, and each empty reference becomes a deficiency that has to be answered after filing rather than before it.

Insight 4: Class A carries a Declaration of Conformity obligation as well. The CMDN document list for Class A includes both the Declaration of Conformity and the Declaration of Shelf Life. The content is lighter than the CSDT set, but these remain formal documents that must be signed and retained on file. This confirms the pattern that runs through the classification system: the Class A file is light, but the obligations attached to it are not. Companies that treat the Class A route as a purely administrative notification sometimes discover this only when a signed declaration is requested and no authorised signatory is available to provide one.

4. Practical recommendations

• Write every entry in the four-part structure. Principle, then method expressed as standard plus test plus result, then evidence number, then conclusion.
• Give reasons for principles that do not apply. An empty entry is read as a missing entry, not as a justified exclusion.
• Compile the checklist last and place the evidence first. Confirm that every citation resolves to a specific report number before the file is finalised.
• Use the checklist as an internal compliance map. It doubles as a self-check that the product actually satisfies every essential principle, not merely that a document says so.

Read together, these four points turn the checklist from a bureaucratic appendix into a working instrument. The four-part structure forces the argument to be explicit, the rule on inapplicable principles removes the most common silent gap, the drafting order guarantees that citations resolve, and the internal-map habit surfaces substantive product issues while there is still time to address them.

5. Verification checklist

• □ Essential Principles Checklist complete, with no entry left empty
• □ Every entry states method, result and a report number
• □ Inapplicable principles carry a written justification
• □ Declaration of Conformity signed by the product owner, original verified
• □ Declaration of Shelf Life present with the basis for the claimed shelf life
• □ Cross-references to other modules consistent, with report numbers cross-checked

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