Filing Multiple Models: Qualification Criteria for Medical Device Grouping

1. Key takeaways

The Philippines has released a draft of the Guidelines on the Qualification Criteria for Grouping of Medical Devices in Product Registration for public comment. The draft would allow several devices to be combined into a single registration application where they share the same product owner, the same risk class, the same brand name, a common intended use, and a common design and manufacturing process. As of the verification date the guideline remains at the consultation stage and has not entered into force, so current CDRRHR practice continues to govern.

• The document is still a Draft for Comments, not an issued circular. It cannot be relied on as a basis for commitments to clients or to management.
• The eligibility test is cumulative: same owner, same risk class, same brand name, common intended use, common design and manufacturing process.
• IVDs are outside the scope of the draft, consistent with the way AO No. 2018-0002 and FC No. 2022-008 treat IVDs.
• Kits and reagent kits containing medicinal products, medicinal boxes containing devices, and device-medicinal combination products are excluded.
• Budget and schedule should still be built on one application per model until the guideline is formally issued and its transition arrangements are known.

2. Legal basis

The draft is titled Guidelines on the Qualification Criteria for Grouping of Medical Devices in Product Registration and remains a Draft for Comments as of 27 October 2026. Its parent provisions are Section 10(g)(1) of RA No. 3720 as amended by RA No. 9711, which defines a medical device, together with Section VII.E item 11, and Section VII.A items 2.c and 2.f, of Book I of the RA No. 9711 Implementing Rules and Regulations. The scope covers manufacturers, traders and distributors, including importers, exporters and wholesalers, who apply for product registration, and expressly does not cover IVDs. The operative administrative order today remains AO No. 2018-0002 of 26 January 2018.

3. Expert insights

Once the grouping rule lands, it will change the cost structure of multi-model portfolios. In a market without grouping, every model needs its own application, its own fee and its own maintenance. A grouping rule allows models that meet the family definition to be merged into one registration application, which reduces official fees, dossier volume and the ongoing cost of maintaining the registrations. For manufacturers with broad product lines, such as imaging systems, monitoring devices or consumable ranges, this is a material benefit rather than a procedural convenience.

Of the five draft conditions, common design and manufacturing process is the hardest to satisfy. Same owner, same risk class, same brand name and common intended use are relatively straightforward to demonstrate. Common design and manufacturing process requires that the differences between models do not touch the design principle or the manufacturing flow. Differences in appearance or dimensions will usually qualify; differences in working principle, in critical components or in process flow mean the models are not in the same family, however similar they look on a price list.

IVDs are expressly outside the grouping rule. The draft states that the circular applies to manufacturers, traders and distributors applying for product registration, excluding in vitro diagnostic medical devices. This mirrors the consistent treatment of IVDs in AO No. 2018-0002 and FC No. 2022-008. IVDs in the Philippines continue to run on a separate track, and an IVD portfolio should be planned without any assumption of grouping relief.

At draft stage, do not make commitments on the basis of the rule. GRZAN’s position is that the grouping rule deserves attention and advance preparation, but project schedules and budgets should still be estimated on the current one-model-one-application basis. There are two reasons. The draft may be modified before issuance, and even once issued it would normally carry a transition period. Preparing product files in family logic is worthwhile groundwork; promising a client that fewer applications will be needed is not, until the text is final.

4. Practical recommendations

• Organise product files in family logic now. Group every model against the five criteria of owner, risk class, brand, intended use and design and manufacturing process, and produce a family list that can be applied the moment the rule takes effect.
• Confirm current practice separately before filing. Ask CDRRHR whether grouped filing is being accepted and on what conditions, and keep the written answer with the project file.
• Do not widen the filing scope in order to create a grouping. Forcing models that do not share a common design and process into one application risks the return of the entire application, including the models that would otherwise have passed.
• Plan IVD lines separately. The grouping rule does not apply, so IVD timelines and fees should continue to be built on individual applications.
• Watch the transition arrangements. When the guideline is issued, check whether applications already in the queue can be regrouped, because that determines whether waiting is worthwhile.

5. Verification checklist

• □ Formal status of the grouping guideline checked on the FDA website (Draft for Comments or issued circular).
• □ Five family conditions verified: owner, risk class, brand, intended use, design and process.
• □ IVD status confirmed as excluded (draft Section III).
• □ Combination product status confirmed: medicated kits, medicinal boxes and device-drug combinations are excluded.
• □ Current CDRRHR position obtained in writing before any grouped filing.
• □ Budget still estimated on one application per model.

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