French Polynesia — Medical Device Regulatory Gap Assessment
Prepared by: RegDesk Regulatory Intelligence Unit | Date: July 8, 2026 | Version: 1.0
Regulatory Authority: Direction de la Santé de Polynésie française (DSP) — https://www.service-public.pf/dsp/
📋 Executive Summary
French Polynesia is a French Overseas Collectivity (Collectivité d'outre-mer) under Article 74 of the French Constitution. It has broad autonomous self-governance since its 2004 Statute of Autonomy. French Polynesia enacts its own laws ("Lois du pays") via its Assemblée de la Polynésie française.
⚠️ CRITICAL: The EU Medical Device Regulation (EU 2017/745) does NOT apply. The French national Code de la Santé Publique does NOT automatically apply. French Polynesia enacts its own laws via its own legislature.
OVERALL FINDING: No dedicated medical device regulatory framework has been identified in French Polynesia. Medical devices are imported and used without pre-market authorization requirements. Regulatory coverage is largely absent across all standard tiles.
📊 Summary Statistics
| Status | Count |
|---|
| ❌ Full Gap | 17 |
| ⚠️ Partial Coverage | 4 |
| ℹ️ Not Applicable | 3 |
| TOTAL | 24 |
⚖️ Legislation Module
| # | Law Title | Type | Year | Status | Reference |
|---|
| 1 |
Loi organique n° 2004-192 du 27 février 2004 portant statut d'autonomie de la Polynésie française |
Organic Law |
2004 |
Active |
legifrance.gouv.fr |
| 2 |
Loi du pays n° 2026-4 du 15 mai 2026 — Code des douanes de Polynésie française |
Customs Law |
2026 |
Active |
assemblee.pf |
| 3 |
Arrêté n° 1771 CM du 26 août 2021 portant organisation de la Direction de la Santé |
Ministerial Decree |
2021 |
Active |
lexpol.cloud.pf |
| 4 |
Loi du pays n° 2017-25 du 27 juillet 2017 relative à la prévention et à la gestion des déchets en Polynésie française |
Environmental Law |
2017 |
Active |
lexpol.cloud.pf |
| 5 |
Arrêté n° 3149 CM du 20 novembre 2019 fixant les modalités de gestion de certaines catégories de déchets |
Implementing Decree |
2019 |
Active |
lexpol.cloud.pf |
| 6 |
EU MDR (EU) 2017/745 |
EU Regulation |
2017 |
NOT APPLICABLE |
— |
| 7 |
EU IVDR (EU) 2017/746 |
EU Regulation |
2017 |
NOT APPLICABLE |
— |
🗂️ Tile-by-Tile Assessment (24 Tiles)
❌ Tile 1 — QMS (Quality Management System) Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None identified |
| Finding | No QMS requirements for medical device manufacturers or importers. DSP's internal Cellule biomédicale (Arrêté n° 1771 CM, 2021) manages hospital equipment maintenance only — not a manufacturer QMS requirement. |
| Recommendation | Flag as regulatory gap. Note international ISO 13485 best practice. |
❌ Tile 2 — Clinical Trials Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None identified |
| Finding | No specific law governing medical device clinical trials. DSP conducts epidemiological surveillance but no clinical trial framework for medical devices exists. It is unclear whether the French national Jardé Law (n° 2012-300) applies by administrative practice. |
| Recommendation | Flag as gap. Seek clarification from DSP on Jardé Law applicability. |
⚠️ Tile 3 — Importation Partial Coverage
| Status | ⚠️ Partial Coverage |
| Gap Level | Partial |
| Reference Laws | Loi du pays n° 2026-4 du 15 mai 2026 — Code des douanes de Polynésie française (assemblee.pf) |
| Finding | A Customs Code was enacted in 2026. Medical devices pass through standard customs (general goods import). No dedicated pre-market authorization, registration, or import permit system for medical devices exists. DSP's Pharmacie d'approvisionnement handles internal DSP facility supply only — not a market authorization mechanism. |
| Recommendation | Document customs process as partial coverage. Flag medical device authorization requirement as a regulatory gap. |
❌ Tile 4 — UDI (Unique Device Identification) Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None. EU EUDAMED/UDI system does not apply. |
| Finding | No UDI system implemented. No local UDI database, no AIDC/HIBC/GS1 requirement. |
| Recommendation | Full gap. |
❌ Tile 5a — Labeling — General Requirements Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None identified |
| Finding | No specific general labeling requirements for medical devices identified. |
| Recommendation | Full gap. |
⚠️ Tile 5b — Labeling — Language Partial Coverage
| Status | ⚠️ Partial Coverage |
| Gap Level | Partial |
| Reference Laws | None specific to medical devices. French is the official language per constitutional framework. |
| Finding | French is the official language of French Polynesia. No law explicitly mandates French-language labels for medical devices. French-language labels are consistent with practice but no formal mandate confirmed. |
| Recommendation | Note French as de facto official language. Flag explicit mandate as a gap; recommend authority contact. |
❌ Tile 5c — Labeling — Primary Packaging Label Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None |
| Finding | No specific requirements for primary packaging labeling of medical devices. |
| Recommendation | Full gap. |
❌ Tile 5d — Labeling — Secondary Packaging Label Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None |
| Finding | No specific requirements for secondary packaging labeling of medical devices. |
| Recommendation | Full gap. |
❌ Tile 5e — Labeling — e-IFU Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None. EU 2021/2226 does not apply. |
| Finding | No regulation on electronic Instructions for Use for medical devices. |
| Recommendation | Full gap. |
❌ Tile 5f — Labeling — IFU (Instructions for Use) Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None |
| Finding | No requirements for IFU language, format, or mandatory content. |
| Recommendation | Full gap. |
❌ Tile 5g — Labeling — Labeling Format Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None |
| Finding | No format specifications (font size, layout, structure) for medical device labels. |
| Recommendation | Full gap. |
❌ Tile 5h — Labeling — Symbol Requirements Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None. EU MDR symbol requirements (ISO 15223-1) do not apply. |
| Finding | No mandatory standardized symbol requirements for medical device labels. |
| Recommendation | Full gap. |
ℹ️ Tile 6 — CE Marking Not Applicable
| Status | ℹ️ Not Applicable |
| Gap Level | N/A |
| Reference Laws | EU 2017/745 — NOT applicable. EU 2017/746 — NOT applicable. |
| Finding | French Polynesia is NOT part of the EU or EEA. CE marking is neither required nor sufficient for legal market access in French Polynesia. No local conformity marking scheme has been enacted. |
| Recommendation | Document as not applicable. Flag absence of any local conformity marking requirement as a regulatory gap. |
❌ Tile 7 — Advertisement & Promotion Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None specific to medical devices |
| Finding | No sector-specific regulation for medical device advertising or promotion identified. General consumer protection principles may apply. |
| Recommendation | Full gap. |
❌ Tile 8 — Packaging Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None specific to medical devices |
| Finding | No medical device-specific packaging requirements (materials, sterile barrier, design) found. |
| Recommendation | Full gap. |
❌ Tile 9 — Cybersecurity Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None |
| Finding | No cybersecurity requirements for connected or software-based medical devices. |
| Recommendation | Full gap. |
❌ Tile 10 — Post Market Surveillance (PMS) Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | Arrêté n° 1771 CM du 26 août 2021 — covers disease surveillance only, not device PMS. |
| Finding | DSP's Bureau de Veille Sanitaire monitors public health/infectious diseases under International Health Regulations. No medical device PMS system, PSUR requirement, or PMCF framework identified. |
| Recommendation | Full gap for device-specific PMS. |
⚠️ Tile 11 — Adverse Event Reporting Partial Coverage
| Status | ⚠️ Partial Coverage |
| Gap Level | Partial |
| Reference Laws | Arrêté n° 1771 CM du 26 août 2021 portant organisation de la Direction de la Santé (Bureau de Veille Sanitaire)
Contact: veille.sanitaire@administration.gov.pf / (+689) 40.48.82.01 |
| Finding | DSP has a general undesirable event ('événement indésirable') reporting system and mandatory disease notification (maladies à déclaration obligatoire). These cover infectious diseases and food-related incidents — NOT medical device adverse events. No device vigilance database, no mandatory device-incident reporting mechanism. |
| Recommendation | Partial coverage for general health adverse events. Full gap for device-specific vigilance. |
❌ Tile 12 — Recalls Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None identified |
| Finding | No medical device recall regulation, mandatory procedure, or authority mandate. No equivalent of FDA MedWatch, ANSM recall framework, or any recall database. |
| Recommendation | Full gap. |
ℹ️ Tile 13 — Renewals Not Applicable
| Status | ℹ️ Not Applicable |
| Gap Level | N/A |
| Reference Laws | None |
| Finding | No device registration system exists in French Polynesia; therefore no renewal requirements apply. |
| Recommendation | Not applicable — predicated on a registration system that does not exist. |
❌ Tile 14 — Timeline & Fees Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None |
| Finding | No established service fees or regulatory timelines for medical device authorization, as no authorization system exists. |
| Recommendation | Full gap. |
❌ Tile 15 — e-Submission Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None |
| Finding | No electronic submission portal for medical devices. DSP has a general health professional portal (service-public.pf/dsp/) but no device-specific e-submission tool. |
| Recommendation | Full gap. |
❌ Tile 16 — Battery Requirements Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None |
| Finding | No battery safety, compliance, or disposal requirements specific to medical devices. |
| Recommendation | Full gap. |
❌ Tile 17 — Shelf-Life Requirements Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None |
| Finding | No shelf-life validation or stability requirements for medical devices found. |
| Recommendation | Full gap. |
ℹ️ Tile 18 — REACH Not Applicable / No Local Equivalent
| Status | ℹ️ Not Applicable / ❌ No Local Equivalent |
| Gap Level | N/A (EU scope) / Full Gap (local) |
| Reference Laws | EU REACH (EC 1907/2006) — NOT applicable. |
| Finding | EU REACH does not apply. No local chemical substances legislation equivalent to REACH for medical devices identified. |
| Recommendation | Document EU REACH non-applicability. Flag absence of local chemical substance controls as a gap. |
ℹ️ Tile 19 — RoHS Not Applicable / No Local Equivalent
| Status | ℹ️ Not Applicable / ❌ No Local Equivalent |
| Gap Level | N/A (EU scope) / Full Gap (local) |
| Reference Laws | EU RoHS (2011/65/EU) — NOT applicable. |
| Finding | EU RoHS does not apply. No local restriction on hazardous substances in electrical/electronic medical device equipment found. |
| Recommendation | Full gap locally. |
❌ Tile 20 — Change Control Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None |
| Finding | No requirement to notify the authority of design, material, software, or manufacturing changes to marketed devices. |
| Recommendation | Full gap. |
❌ Tile 21 — OTC Requirements Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None specific to OTC medical devices |
| Finding | No OTC-specific medical device rules. General retail/consumer law may apply but no device-specific OTC framework found. |
| Recommendation | Full gap. |
❌ Tile 22 — Export Certificates Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None |
| Finding | No formal procedure identified for DSP or any authority to issue export certificates (CFS, CFG, Health Certificate) for medical devices. |
| Recommendation | Full gap. |
❌ Tile 23 — Transportation & Storage Full Gap
| Status | ❌ Full Gap |
| Gap Level | Full Gap |
| Reference Laws | None specific to medical devices |
| Finding | No transport or storage requirements specific to medical devices identified. General goods transport rules may apply. |
| Recommendation | Full gap. |
⚠️ Tile 24 — Waste Management Partial Coverage
| Status | ⚠️ Partial Coverage |
| Gap Level | Partial |
| Reference Laws |
• Loi du pays n° 2017-25 du 27 juillet 2017 relative à la prévention et à la gestion des déchets en Polynésie française (lexpol.cloud.pf)
• Arrêté n° 3149 CM du 20 novembre 2019 fixant les modalités de gestion de certaines catégories de déchets (lexpol.cloud.pf)
|
| Finding | French Polynesia has a general waste management law (2017) covering hazardous waste (déchets dangereux). Medical waste (déchets d'activités de soins — DASRI) is likely covered under the general hazardous waste framework, but no device-specific WEEE/e-waste or end-of-life medical device regulation was identified. |
| Recommendation | Partial through general waste law. Research DASRI-specific provisions further. Recommend direct DSP inquiry. |