Compliance runs inside the operation.
Vigilance, adverse-event reporting, marketing review and data protection run inside the same operation that holds the licence, imports the device and sells it. This page sets out who carries which obligation.
Alzey Danışmanlık ve Ticaret Ltd. Şti. — Master Distributor for Allurion Swallowable Gastric Balloon and Allurion VCS across Türkiye and the CIS · registration holder and importer.
- Signal
- Case log
- Assessment
- Authority filing
- Manufacturer loop
- Closure
- Signal
- Case log
- Assessment
- Authority filing
- Manufacturer loop
- Closure
Vigilance & adverse events
We carry medical-device vigilance obligations and the adverse-event reporting flow under authorised-distributor responsibility.
When a signal comes in from the field we log the case, assess it, file with the competent authority where a report is required, and close the loop in coordination with the manufacturer. The record, the follow-up and the correspondence sit with us.
Why compliance sits inside the operation
Compliance retrofitted after market entry tends to live in a binder: the obligations get listed, yet nobody in the field owns them, and the first real test is an incident. When that happens in a distribution channel, the damage attaches to the manufacturer's name.
We built the layer the other way round. The licence sits in our name and the channel that sells the device is ours to run, so the distributor-level obligations attach to us directly. Field vigilance, the adverse-event reporting flow, marketing review and the data-processor role move in the same rhythm as import, stock and collections. For a manufacturer that means one counterparty in Türkiye.
Regulatory service items
- Regulatory feasibility and classification assessment
- Label and Turkish IFU compliance check
- Technical file compilation and gap analysis
- TİTCK application file and official follow-up
- ÜTS registration and product numbering
- Promotional material compliance review
- Change notifications (minor/major) and renewals
- Vigilance and adverse-event reporting
The full narrative sits on the medical operations page.
Operating layers of compliance
Marketing compliance (Red/Amber/Green)
Every outbound piece passes a three-tier lens:
- Red
- non-compliant, not published (e.g. superlative clinical claims, patient testimonials, before/after imagery, price statements). There is no rework path at this tier; the piece is dropped.
- Amber
- needs evidence/qualifier, not released until fixed. The piece waits until the source is attached or the wording is qualified.
- Green
- sourced and compliant. Only this tier reaches publication.
Turkish advertising rules (12.11.2025), including the brand-name restriction on clinic-facing content, are coded into this lens.
Quality system and certification
Quality-management certification is a standard line in any manufacturer's assessment of a distribution partner. We won't present ourselves as further along than we are.
We do not hold ISO 13485 today, and we carry no standard on this site that we cannot evidence. ISO 13485 certification is a defined work item on our quality-system roadmap; once the certificate is issued it will be published in this section with its date and number.
Regulatory status
- FDA
- PMA Class III full approval· 23.02.2026
- CE
- CE 0123 (TÜV SÜD) — Article 120 transition regime
- Türkiye
- TİTCK licensed · ÜTS registered
Regulatory status may change; consult official TİTCK and FDA records for the current position.
Data protection — role split
Data-controller responsibility splits by the data flow:
For Allurion Program patient/clinical data
Data Controller = Allurion Inc. · Türkiye Representative = Kavlak · Alzey = Data Processor.
For Alzey’s own corporate forms (partnership / contact)
Data Controller = Alzey Danışmanlık ve Ticaret Ltd. Şti.
The full notice covering corporate-form data sits in our Data Protection Notice (KVKK).