Ecuador Multiple References and Kits: Entry Caps, Combined Certificates and Set Rules

1. Key takeaways

The new regulation sets clear structural rules for one certificate covering many models: the per-application entry cap is 100 entries for devices and 50 entries for in vitro diagnostics (DMDIV) (Article 10 applies to general registration and variations, Article 32 to simplified registration); the conditions for combining models under one certificate are listed separately for devices and IVDs in Article 14; sets/kits may be covered by a combined certificate under Article 15, and Article 16 provides that their validity period follows the shortest service life among members while their risk class follows the highest risk. These rules reward careful product-line architecture before any filing is made.

2. Legal basis

Correction note: some Chinese and English sources misstate the 50-entry cap as 50 class IV risk products. The official text refers to 50 entries for DMDIV (in vitro diagnostic medical devices), which is unrelated to risk class. The original wording of Article 32 reads: cien (100) ítems o referencias… para el caso de DMI, DMNI y DMA y cincuenta (50) ítems para DMDIV. Planning based on the misreading would seriously distort IVD portfolio grouping.

3. Expert insights

Insight 1: the combining conditions differ between devices and IVDs and cannot be interchanged. Article 14 has two paragraphs:

• Devices may be combined under one certificate where they share the same: device type, risk class, product owner (titular del producto), manufacturer, and intended use as declared by the product owner;
• IVDs may be combined under one certificate where they share the same: risk class, analytical methodology (metodología analítica), analyte group to be investigated (grupo a investigar), manufacturer, intended use, and product owner.

The two IVD-specific conditions of analytical methodology plus analyte group mean that reagents using different methodologies or detecting different analytes cannot be combined under one certificate, even where the risk class is identical. ARCSA will issue separate instructions determining the grouping and methodology criteria, so the boundaries may still move.

Insight 2: sets and systems have different combining conditions. Article 15 distinguishes two categories:

• Sets (sets/kits): where commercial packaging contains two or more devices combined for a specific therapeutic or diagnostic purpose, a substantive justification is required, and the components must be packed in the same container or package;
• Systems (sistema): devices forming a system may be combined under one registration number provided it is demonstrated that they are dedicated to the operation of that system and belong to the same manufacturer.

Insight 3: the two derivative rules of Article 16 create the weak-link effect for sets. The validity period of a set equals the shortest service life among its members, and its risk class equals the highest risk among them. Packaging a short-life consumable together with a long-life device therefore shortens the validity of the entire package. Portfolio managers should model these derivative effects before deciding what goes into a set.

Insight 4: Articles 10 and 11 together impose a fix-once constraint, yet Article 10 also provides the expansion path. Article 10 provides that applications exceeding the cap are not reviewed until the applicant corrects them, and Article 11 provides that entries may not be added or changed after submission. However, Article 10 also states that once an application with 100 entries (devices) is approved, the holder may add further entries through a variation application. This creates a lawful path for phased expansion of multi-model product lines, effectively treating the first certificate as the anchor of the portfolio.

Insight 5: packaging strategy is directly linked to official fees. Because registration, renewal and variation each require payment (Article 8), while a single certificate can cover dozens of models, spreading official fees across a series of models is the core cost optimization lever for multi-product-line companies. The saving compounds further at renewal, when the same certificate structure is maintained at a single fee rather than one fee per model.

4. Practical recommendations

1. Group models under the Article 14 conditions: devices by the five-way identity of type plus class plus owner plus manufacturer plus intended use; IVDs additionally by methodology plus analyte group.
2. Model the weak-link effect before assembling a set: confirm that the shortest-life member does not cut the package validity unacceptably short.
3. Lock the model list once before submission and pre-plan phased expansion through variation applications for additional entries.
4. Split product lines above 100/50 entries into multiple applications, sequenced by market priority.
5. Record the weakest member of each set in the certificate register to support renewal and validity management.

5. Verification checklist

• □ Completed model grouping under the Article 14 conditions (five-way for devices / seven-way for IVDs)
• □ Checked the entry caps (100 entries for devices / 50 for DMDIV)
• □ Locked the model list before submission
• □ Completed the dual calculation of shortest service life and highest risk for each set
• □ Prepared the phased expansion plan for models above the cap
• □ Recorded the weakest member information of each set in the certificate register

Regulatory information verified as of October 29, 2026

Core service areas

1. Global market access: EU CE (MDR/IVDR), US FDA (510(k)/De Novo/PMA), UK UKCA, Australia TGA, Canada Health Canada, Brazil ANVISA and Russia RZN, plus premarket registration pathway planning and filing execution across Latin America, Southeast Asia, the Middle East and other markets.
2. Authorized representative services: EU authorized representative (EC REP), UK responsible person (UK RP), Swiss authorized representative (CH REP), Australia sponsor and US Agent, together with neutral certificate-holder structure design.
3. Quality system compliance: ISO 13485 implementation and maintenance, MDSAP audit preparation, GMP conformity coaching, and technical documentation (TD) authoring and remediation.
4. Clinical and evaluation: clinical evaluation plans (CEP) and reports (CER), equivalence argumentation, PMCF planning and execution, and IVD performance evaluation.
5. Post-market compliance: vigilance and adverse event reporting, FSCA and recall execution, registration change and renewal management, and maintenance of national regulatory databases.

Why GRZAN

• Local regulatory teams: filings in each target market are executed by locally licensed regulatory professionals and prepared directly in the official language of the market, without secondary translation.
• Neutral holding structure: certificate-holding arrangements that are not tied to any distribution channel, keeping registrations independent of channel partners.
• Regional leverage: a single technical dossier can be reused across Andean Community and Mercosur member states, spreading regional compliance cost.
• Full lifecycle support: end-to-end service from classification, pathway design and dossier preparation through certificate holding, customs clearance, post-market vigilance and renewal.

Contact

• GRZAN provides medical device registration support in Ecuador for manufacturers, importers and authorized representatives.
• Email: info@grzanglobal.com
• Service inquiries: Ecuador and Andean market registration plans, certificate-holding structure design, official fee and timeline estimation