Philippines Medical Device Classification: Class A to Class D

1. Key takeaways

The Philippines applies a four-tier risk classification that is fully aligned with the ASEAN Medical Device Directive (AMDD): Class A for low risk, Class B for low to moderate risk, Class C for moderate to high risk, and Class D for high risk. The class is determined from intended use, invasiveness, duration of contact, whether the device is active, and whether software is involved, judged against the GHTF classification rules. The outcome cannot be carried over from a Chinese NMPA classification, and must be re-determined under AMDD rules before any application is prepared.

Classification is the single decision that sets everything downstream, because the class selects the authorisation route, the depth of the technical file, the review queue and the fee band. It is also the decision most often made informally, by an engineer comparing the product to a similar device already on the market rather than by applying the rules to the intended use. When the classification is later overturned, the cost is not only the official fee, which is not refunded, but the whole elapsed period.

• Four classes: A, B, C and D, matching the AMDD risk tiers.
• Class A files a CMDN; Class B, C and D file a CMDR.
• Rules applied: GHTF classification rules, adopted through the ASEAN harmonised technical requirements under ACCSQ-MDPWG.
• Scope limit: AO No. 2018-0002 Section III excludes in vitro diagnostics and refurbished devices, which are governed separately.
• Regional status: the AMDD was signed by the Philippines in 2014 and ratified on 18 November 2020.

2. Legal basis

The operative instrument is DOH Administrative Order No. 2018-0002 of 26 January 2018. Section III defines the scope and carves out two categories, while Section IV carries the definitions that the classification decision is expressed in. The regional framework sits above it: the AMDD supplies the risk tiers and the GHTF rules supply the technical mechanics, so a classification memo normally cites both the ASEAN rule and the Administrative Order clause that gives it domestic effect.

Section III is drafted as a broad scope with a narrow exception, and the exception is easy to miss because it appears at the end of the sentence rather than in a separate provision. The order applies to all medical devices sold, imported, exported, manufactured and used in the Philippines, except in vitro diagnostic devices and refurbished medical devices, which are the subject of separate administrative orders. In practice this means the first question about any new product is not which class it belongs to, but which instrument governs it at all.

3. Expert insights

Insight one: classification decides the pathway, not the label on the certificate.

In the Philippines, the class does not determine a grade of certificate so much as which route the product travels. Class A goes through notification and receives a CMDN. Class B, C and D go through registration and receive a CMDR. The two routes differ in the depth of documentation, the length of review and the structure of fees. Filing a Class B product as a Class A notification is the most common and the most damaging route error, because once the class is found to be wrong the entire application is returned and the process restarts from the beginning rather than being converted in place.

Insight two: AMDD rules and NMPA rules produce different answers for several product families.

The AMDD grades invasive devices by duration of contact and by the anatomical site invaded, grades active devices by the mode of energy transfer and by criticality, and grades software by its contribution to diagnosis or treatment. Manufacturers in China often reason by intuition from the familiar Class II and Class III categories, yet the two systems derive from different sources: the NMPA system from a national catalogue, the AMDD from the GHTF rules. A product landing in a different tier is not unusual. We recommend preparing a dedicated classification determination memo before filing, recording the rule numbers applied, the reasoning for each determination, and the registration numbers of comparable cleared products. The memo serves internal decision-making and also serves as the basis for any conversation with CDRRHR.

Insight three: the exclusion of IVDs and refurbished devices is the first gate in the classification exercise.

Because Section III removes these two categories from the scope of AO No. 2018-0002, the first step with an IVD is not to assign A, B, C or D under the device rules but to confirm which rule set governs it. Treating the exclusion as a footnote is a recurring error, and it usually surfaces late, after a technical file has been assembled against the wrong template. The same logic applies to refurbished equipment, where the relevant question is the remanufacturing status of the unit rather than its original classification.

Insight four: there is an official route for resolving ambiguity.

Where the application of the rules is genuinely unclear, a classification enquiry can be submitted to CDRRHR. Our experience is that it is better to resolve classification before filing than to defend it in a deficiency response. Once a classification is reversed, the official fees already paid are not refunded and the clock restarts, so a short written enquiry is almost always cheaper than a resubmission.

4. Practical recommendations

• Judge from intended use, not from product form. The first input to classification is the intended use, not the hardware. The same physical device can fall into different classes depending on what it is indicated for. Chinese technical files frequently describe indications more broadly than a Philippine filing needs, and the wording should be narrowed to match the use actually being applied for.
• Cross-check against comparable cleared products. Search the FDA Verification Portal for the registration numbers and classes of similar products and use them as third-party corroboration. This carries weight both in internal review and in correspondence with the centre.
• Determine the primary function first for combination products. Products that combine device and drug functions, and devices containing medicinal substances, do not follow the ordinary device classification route under AO 2018-0002 and require a separate determination of which regime applies before any dossier work starts.

5. Verification checklist

• □ Confirm the classification rule set against the AMDD rules and AO No. 2018-0002.
• □ Confirm whether the product is an IVD by checking the Section III exclusion in AO No. 2018-0002.
• □ Confirm whether the product is a refurbished device, which is excluded on the same basis and covered by a separate administrative order.
• □ Compare the NMPA class with the AMDD class line by line and record every point of divergence.
• □ Confirm the class of comparable cleared products through the FDA Verification Portal.
• □ Confirm the regime applicable to any combination product with CDRRHR before filing.

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