CCT Special Requirements by Risk Class: What B, C and D Add

1. Key takeaways

The special requirements of Article 37 of Decreto Ejecutivo N° 490 are cumulative, class by class. A class A device only has to satisfy the thirteen general requirements, with nothing added. A class B device adds two items to the class A baseline: the sterilisation process used for sterile products, and the sterilisation and/or cleaning method to be applied to reusable devices. A class C device adds two further items to the A and B baseline: a summary of clinical studies or trials on safety and effectiveness, and a description of the manufacturing and packaging materials, both of which are disapplied for biomedical equipment. A class D device adds four items on top of A, B and C: risk analysis and the safety measures adopted to reduce risk, a traceability protocol, detailed information on clinical and preclinical safety and effectiveness studies, and, optionally, a currently valid ISO 13485 certificate.

The logic is a staircase rather than a menu. Each class inherits everything required of the class below it, so a class D file contains the whole class A, B and C set before its own four items begin. The practical consequence is that a dossier cannot simply be upgraded at the margin when a product is reclassified upward; the underlying structure has to carry the additional layers from the start.

• Class A: the thirteen general requirements only.
• Class B: two microbiology-related additions.
• Class C: a clinical summary and a materials description, both disapplied for biomedical equipment.
• Class D: risk analysis, traceability protocol, detailed clinical and preclinical information, and an optional ISO 13485 certificate.
• Class C and D files are evaluated with at least two specialist users of the relevant specialty taking part.

2. Legal basis

Article 37 of Decreto Ejecutivo N° 490 of 4 October 2019 sets out the special requirements by risk class in four numbered items, one per class. Articles 31 and 33 of the same decree govern how the evaluation itself is conducted and explain why the documentary burden rises with the class.

Two of the four items carry internal exclusions. The clinical summary and the materials description in item 3 do not apply to biomedical equipment, which follows the same pattern as items 8, 12 and 13 of the general list. The optional ISO 13485 certificate in item 4 is the only place in Article 37 where a requirement is expressed as discretionary, and that wording has to be read together with the amendment made to Article 36.

3. Expert insights

Insight one: the ISO 13485 certificate for class D is described as optional, but item 10 of the general requirements has made it substantively mandatory. Article 37, item 4(d) reads Certificado ISO 13485 vigente de manera opcional, a currently valid ISO 13485 certificate, optional. That word reflects the 2019 text and belongs to the column of class D special requirements. Decreto Ejecutivo N.º 416 has since rewritten item 10 of Article 36 as a mandatory current ISO 13485 certificate, and a class D device must satisfy every general requirement. The optional space therefore no longer exists in practice. This is the typical case of a lower and a higher provision in tension, resolved in favour of the amended text, and it is exactly why the amendment status of each article has to be checked line by line.

Insight two: both class B additions point at microbiological control. Items 2(a) and 2(b) address the sterilisation process for sterile products and the sterilisation or cleaning method for reusable devices respectively. The substance is that class B is where devices begin to be invasive or to come into contact with the patient, so microbiological control becomes a review concern. A class B dossier should therefore carry validation material covering both dimensions, the process at the manufacturing end under (a) and the method at the point of use under (b). Supplying only one of the two is treated as an incomplete submission.

Insight three: the clinical requirement stops at a summary for class C and only becomes detailed information for class D. Article 37, item 3(a) asks for a Resumen de estudios o ensayos clínicos, a summary of studies or clinical trials, while item 4(c) asks for Información detallada de estudios clínicos y preclínicos, detailed information on clinical and preclinical studies. The gradient is deliberate: class C is assessed on the conclusions, class D on the whole process. A class D file therefore needs the depth of a complete technical documentation set, and the volume of material is typically several times that of a class C file.

Insight four: the traceability protocol is a stand-alone class D requirement and echoes the implant traceability rule in Article 62. Item 4(b) requires class D applicants to submit protocolos de trazabilidad, with the qualifier cuando lo requiera el fabricante, when the manufacturer so requires. This does not conflict with Article 62, under which traceability of implantable devices is mandatory. Article 62 addresses the post-market traceability obligation for implants, while Article 37, item 4(b) addresses the protocol document at the time of application. Together they form a continuous chain from filing through to use.

4. Practical recommendations

• List the additional requirements of Article 37 against the final risk class, and do not reuse the document structure of a lower class when a product has been reclassified upward.
• For class B, prepare two sets of microbiological control material: the sterilisation process at the manufacturing end and the sterilisation or cleaning method at the point of use.
• For class C, prepare a clinical summary that states the objective, design, sample size, primary endpoints and conclusions of each study.
• For class D, prepare clinical and preclinical material to the detailed information standard, and attach the risk analysis under item 4(a) and the traceability protocol under item 4(b).
• Always prepare the ISO 13485 certificate as a mandatory document and never rely on the optional wording in Article 37, item 4(d).
• Confirm the final risk class with the authority before the dossier structure is fixed, since the whole documentary staircase depends on that classification.

5. Verification checklist

• □ Final risk class confirmed as A, B, C or D
• □ Additional requirements listed class by class against Article 37
• □ Class B: sterilisation process and sterilisation or cleaning method both present
• □ Class C: clinical summary and manufacturing and packaging materials description both present
• □ Class D: risk analysis, traceability protocol and detailed clinical and preclinical information all present
• □ ISO 13485 certificate prepared as mandatory under item 10 of the general requirements
• □ Where the class C or D route applies, the evaluation panel includes at least two specialist users of the relevant specialty

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Panamanian market. Our team manages Ministry of Health (MINSA) sanitary registration applications, prepares Spanish-language dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com

Regulatory information verified as of 29 October 2026.