1. Device Classification REGULATED — PARTIAL DATA

Status: French Polynesia follows a device classification framework that mirrors the French/EU model, given the historical alignment of its health system with French metropolitan practice. Devices are categorised by risk level.

Available Information

• Classification broadly follows 4 classes: Class I (low risk), Class IIa (medium-low), Class IIb (medium-high), Class III (high risk), aligned with historical French practice prior to EU MDR.
• In-vitro diagnostic devices (IVDs) classified separately.
• DSPF is the competent authority for classification determinations.
• Active implantable devices treated as high-risk (Class III equivalent).

Laws & References

2. Market Authorization / Registration UNCLEAR

Status: No formal pre-market approval or registration system for medical devices has been confirmed for French Polynesia. The system appears to rely primarily on CE marking as a quality proxy, with import notification obligations through customs/Direction des affaires économiques.

Available Information

• Devices bearing CE marking (or equivalent conformity mark) may be placed on the market without separate Polynesian pre-market authorisation.
• Importers and distributors must register with commercial authorities; no separate device register confirmed.
• DSPF may require notification or documentation for certain high-risk devices or novel technologies.
• Class III / active implantable devices may face stricter DSPF scrutiny at importation.
• No FIMEA-/TGA-/ANVISA-style device register found for French Polynesia.

Laws & References

3. Quality Management System (QMS) UNCLEAR

Status: No specific QMS regulation (equivalent to ISO 13485 requirement or GMP decree for medical devices) has been identified in local Polynesian law. Quality requirements are implicitly tied to CE marking requirements for imported devices.

Available Information

• ISO 13485 compliance is implicitly expected for manufacturers who hold CE marking (required by EU MDR/MDD for CE certification) — but this is not a locally enacted QMS requirement.
• DSPF inspections of healthcare facilities may cover quality aspects of medical devices in use.
• No local QMS certification requirement for manufacturers or importers has been identified.
• MDSAP: Not applicable — French Polynesia does not participate in MDSAP.

4. Clinical Trials REGULATED — PARTIAL DATA

Status: French Polynesia has provisions for clinical research / biomedical research under its health code. Research involving human subjects requires ethical review and authorisation from the DSPF.

Available Information

• Biomedical research on human subjects is regulated under the Code de la santé de la Polynésie française.
• An ethics committee (Comité de protection des personnes equivalent, or referral to metropolitan committee) reviews research protocols.
• Investigators must hold appropriate qualifications; sponsor responsibilities apply.
• Clinical investigations of medical devices (as distinct from drug trials) have limited specific local provisions — gap exists.
• PMCF studies and Post-Market Clinical Follow-Up: no local framework confirmed.

Laws & References

5. Importation REGULATED — MODERATE DATA

Status: Medical device importation is regulated. French Polynesia controls imports through customs and the Direction des affaires économiques (DAE). Health product imports require DSPF clearance for certain categories.

Available Information

• Imports require customs declarations through French Polynesia's own customs authority (separate from French metropolitan customs — but aligned with French customs tariff nomenclature).
• Specific health products, including medical devices, may require prior authorisation or notification from DSPF before importation.
• Importers must be duly registered commercial entities in French Polynesia.
• Customs tariff: French Polynesia has its own tariff schedule (not EU CET). Medical device HS codes generally benefit from 0% import duty under WHO/health product provisions, but local rates must be confirmed.
• Temporary importation for clinical use or demonstration may be permitted under special conditions.
• An Authorized Representative (AR) in French Polynesia may be required for non-resident manufacturers — not confirmed by local law.

Laws & References

6. Unique Device Identification (UDI) GAP — NO REGULATION

Status: No UDI system exists in French Polynesia. The EU's UDI/EUDAMED system does not apply. No local law or regulation requiring UDI labelling or registration has been identified.

7. Labeling REGULATED — MODERATE DATA

7a. General Requirements

Medical device labels must meet general health product requirements under the Code de la santé de la Polynésie française. Devices must provide sufficient information for safe use. CE marking requirements serve as a de facto baseline for imported devices.

7b. Language Requirements CONFIRMED

Required language: French. French is the official language of French Polynesia under the Loi organique. All labelling, IFU, and user documentation must be in French. Tahitian (reo Mā'ohi) is a co-official language but not required for medical device labelling.

7c. Primary Packaging Label

Must include at minimum: device name, manufacturer details, lot/serial number, expiry date (if applicable), sterility indicators (if applicable), CE marking (for EU-manufactured devices), storage conditions, and warnings — consistent with French CE marking practice.

7d. Secondary Packaging Label

Same general requirements as primary packaging; IFU reference; quantity.

7e. IFU (Instructions for Use)

Must be provided in French. General health product requirements apply. No specific local IFU decree confirmed beyond language requirement.

7f. e-IFU GAP

No local e-IFU regulation identified. EU Commission Regulation (EU) 207/2012 on e-IFU does not apply.

7g. Symbol Requirements

ISO 15223-1 symbols are widely used and likely recognised, particularly for imported devices. No local standard mandating specific symbols beyond CE marking confirmed.

Laws & References

8. CE Marking / Conformity Assessment REGULATED — MODERATE DATA

Status: CE marking is recognised in French Polynesia as evidence of conformity for medical devices imported from the EU/EEA. However, CE marking is not legally mandated by local law for all devices — its recognition is practical/customary rather than legislative.

Available Information

• Devices with CE marking under the EU Medical Device Directive (93/42/EEC, now transitioning per EU MDR) are generally accepted without separate conformity assessment.
• No local Notified Body exists in French Polynesia.
• Conformity assessment is performed by EU Notified Bodies; certificates issued in EU are recognised.
• For devices without CE marking (e.g., from non-EU countries), DSPF may require additional documentation to demonstrate safety and performance.
• No specific local conformity assessment pathway has been established.

Laws & References

9. Advertisement & Promotion UNCLEAR

Status: General advertising rules under French Polynesia's commercial and health laws apply. No specific medical device advertising regulation confirmed.

Available Information

• Health product advertising is subject to general health code provisions — claims must not be misleading.
• Direct-to-consumer advertising of high-risk medical devices is likely restricted, consistent with French practice.
• No DSPF pre-approval process for MD advertising confirmed.

10. Packaging UNCLEAR

No specific medical device packaging regulation confirmed in local law. CE marking requirements (which include packaging requirements per EU MDD/MDR Annex I) serve as a de facto baseline for imported devices. Sterile packaging must comply with applicable ISO standards (ISO 11607).

11. Cybersecurity GAP — NO REGULATION

No cybersecurity regulation for medical devices identified in French Polynesia. The EU MDR Article 18 (implant card + cybersecurity) and MDCG guidance documents do not apply locally.

12. Post-Market Surveillance (PMS) UNCLEAR

Status: DSPF oversees health product safety in the market. No formal PMS framework (PSURs, complaint handling, FSN/FSCA tracking) has been confirmed by local legislation for medical devices.

Available Information

• DSPF has general powers to monitor health products and take corrective action.
• No local requirement for manufacturers to submit PSURs, periodic safety reports, or formal complaint logs to DSPF.
• FSN/FSCA: No local procedure confirmed — manufacturers issuing EU FSNs/FSCAs should voluntarily notify DSPF.

13. Adverse Events / Vigilance Reporting REGULATED — PARTIAL DATA

Status: Health product vigilance is addressed in the Code de la santé de la Polynésie française. Healthcare providers and importers/distributors are expected to report serious incidents to DSPF.

Available Information

• Serious adverse events involving medical devices should be reported to the DSPF.
• No dedicated matériovigilance decree (equivalent to French ANSM's matériovigilance system) has been confirmed for French Polynesia.
• DSPF contact for vigilance: Direction de la Santé, BP 611, Papeete, Tahiti.
• Reporting obligation applies to economic operators (importers, distributors) placing devices on the Polynesian market.

Laws & References

14. Recalls REGULATED — PARTIAL DATA

Status: DSPF has authority to order recall or withdrawal of unsafe health products. Voluntary recall by manufacturers/importers is also possible.

Available Information

• DSPF can issue withdrawal or recall orders for health products including medical devices when a safety risk is identified.
• No formal recall procedure (notification timelines, classes of recall) for MDs specifically confirmed.
• EU recall actions (FSCA) should be communicated to DSPF — no confirmed legal obligation to do so locally.

15. Renewals GAP — NO REGULATION

Since no formal pre-market registration/authorization system has been confirmed, no renewal process exists. If a notification/authorization system is established in the future, renewal requirements would likely follow. Currently not applicable.

16. Timeline & Fees GAP — NO DATA

No official fee schedule for medical device-related DSPF services has been identified. Import customs duties (if any) are administered by Direction des affaires économiques.

17. e-Submission GAP — NO PORTAL

No electronic submission portal for medical devices has been identified for French Polynesia. DSPF manages filings by paper/email. No online regulatory system equivalent to EUDAMED, TGA portal, or CDSCO portal exists.

18. Battery Requirements GAP — NO REGULATION

No specific local battery regulation for medical devices confirmed. CE marking requirements (which include battery safety per applicable standards) serve as a de facto baseline for imported CE-marked devices. No local battery disposal regulation specific to MDs identified.

19. Shelf-Life UNCLEAR

General health code requirements on product expiry apply. No specific shelf-life regulation for medical devices (as distinct from pharmaceuticals) has been confirmed in local law. Expiry dates must appear on labels (implied by general health product labelling rules).

20. REACH / RoHS / Environmental GAP — NOT APPLICABLE

EU REACH (Regulation EC 1907/2006) and EU RoHS Directive (2011/65/EU) do NOT apply to French Polynesia. No equivalent local chemical restriction legislation for medical devices has been identified. General environmental protection laws of French Polynesia apply to waste management but not specifically to MD chemical content.

21. Change Control GAP — NO REGULATION

No change control regulation for medical devices has been identified in French Polynesia. Given the absence of a formal pre-market registration system, change notifications to a regulatory authority are not required.

22. Over-the-Counter (OTC) UNCLEAR

OTC medical devices (e.g., wound care, thermometers, pregnancy tests) are available in pharmacies and general retail in French Polynesia. No specific OTC-designation law for medical devices has been identified. Sales restrictions by device class may apply.

23. Export Certificates UNCLEAR

Manufacturers based in French Polynesia seeking to export devices may require a Certificate of Free Sale or equivalent from DSPF. French Polynesia's small manufacturing base means this is a rare requirement. No confirmed export certificate procedure identified.

24. Transportation / Storage UNCLEAR

General health code requirements on storage conditions for health products apply. Cold-chain requirements for temperature-sensitive devices are implied but no specific MD transportation regulation has been confirmed locally. IATA/ICAO dangerous goods regulations apply to air transport (French Polynesia uses Faa'a International Airport, Papeete).

25. Waste Management / WEEE UNCLEAR

EU WEEE Directive does not apply. French Polynesia has its own environmental protection laws. Medical waste (including end-of-life medical devices, sharps, contaminated devices) is regulated under local environmental / public health rules. No WEEE-specific electronics recycling scheme for MDs confirmed.

Laws & References