Registration Holder and Provider in Panama: Two Separate Legal Roles

1. Key takeaways

Panama splits the notion of a holder into two legal concepts, which is unusual in Latin America. Definition 90 of Article 2 of DE 490 provides that the Titular del producto is the manufacturer; definition 91 provides that the Titular del registro sanitario is the natural or legal person in whose name the corresponding registration certificate is issued. A third role is the proveedor, or supplier: definition 37 of Article 6 of Ley 90 requires it to be a natural or legal person with accredited links (vínculos acreditados) to the manufacturer, engaged in the import, sale, distribution, manufacture and/or final disposal of devices and related products. That accredited link is not satisfied by an ordinary power of attorney. Comunicado No. 009 of 25 September 2023 fixed it in a standard Panama distributor representation letter with six items, a to f, which must be apostilled. While sanitary registration remains closed, the practical holding of a product sits on the combination of the proveedor operating licence and the signature on the CCT.

2. Legal basis

The provisions below are grouped by role rather than by article order, because the practical question is always who carries which obligation rather than what a single article says. The first group defines the three roles, the second governs the link between manufacturer and local party, and the third governs what happens when that link or the manufacturer changes.

3. Expert insights

Insight 1: separating the product holder from the registration holder is the most easily missed feature of the system. Definition 90 fixes the product holder as the manufacturer in a single phrase, while definition 91 defines the registration holder as the signatory of the certificate. The legal meanings are different: the product holder carries design and manufacturing responsibility, and the registration holder carries the filing, change and vigilance obligations attached to the certificate. While registration remains closed, both roles are compressed into the CCT signature and the local proveedor, but once registration opens, the signatory will determine who is first in line for vigilance, recall and change obligations.

Insight 2: the threshold for a proveedor is an accredited link, not a letter of authorisation. Definition 37 of Article 6 of Ley 90 uses the phrase with accredited links to the manufacturer. Comunicado 009 turns that accreditation into an executable form: a standard distributor letter with six items and an apostille. An ordinary authorisation issued by an overseas manufacturer therefore does not satisfy the evidentiary requirement, and a letter in the wrong format or without apostille will stop at the formal review of the dossier.

Insight 3: changing the representative changes the certificate signature, not just a contract. Article 43, second paragraph lists a change of manufacturer information, including the manufacturing site, as a substantial change; Article 67 item 2 lists a change of manufacturer as a ground for CCT cancellation; and item 9 lists revocation of the authorisation as a further ground. Read together, replacing the local representative may result in cancellation rather than amendment, which makes a single representative a condition of the certificate continuing rather than a commercial preference.

Insight 4: revocation of the authorisation reaches the certificate directly. Article 67 item 9 treats revocation as a cancellation ground, which shows that DNDM regards the authorisation relationship between manufacturer and local party as part of the certificate basis. GRZAN therefore usually advises against naming the first distributor that wins a tender, and in favour of placing the representative role in an entity controlled by the manufacturer that can carry vigilance and recall duties, with distribution authorised beneath it.

4. Practical recommendations

• Settle the representative before the distributor. A change of representative affects the CCT under Articles 43 and 67, while distributors can be added or removed at any time. Reversing the order transfers channel risk onto the certificate.
• Issue the letter strictly under Comunicado 009. Use the DNDM format, complete all six items and obtain the apostille in the issuing country; do not reuse a power of attorney from another market.
• Write vigilance and recall duties into the representation agreement. Under Article 52.6 a supplier must designate at least one qualified professional, and under Article 58 a recall requires prior authorisation and domestic traceability, so the agreement must state who reports to DNDM and who produces the traceability data.
• Keep the manufacturer-side evidence chain. ISO 13485 under Article 36 item 10 as rewritten by DE 416, and the manufacturer support letter under Article 25, are the substantive evidence of an accredited link and must be updated alongside the representation letter.
• Assess cancellation risk before changing manufacturer or site. Under Article 43 and its second paragraph with Article 67 item 2, such a change may require a new application rather than an amendment; confirm the current position before scheduling production.

5. Verification checklist

• □ Titular del producto as manufacturer under definition 90 distinguished from titular del registro sanitario as certificate signatory under definition 91
• □ Local proveedor confirmed to have accredited links with the manufacturer under definition 37 of Article 6 of Ley 90
• □ Distributor letter issued in the Comunicado No. 009 format with all six items a to f
• □ Apostille obtained for the representation letter
• □ Agreement states the vigilance officer requirement of at least one person and the recall and traceability data duties
• □ Valid ISO 13485 and the Article 25 manufacturer support letter updated together
• □ Two company-side substantial changes under Article 43 and the cancellation grounds under Article 67 items 2 and 9 flagged to management
• □ Representative change route confirmed, with the certificate not left in the name of a single distributor

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