Regulatory research starts with the legal manufacturer, exact model, intended use and destination country. A certificate image, establishment number or another country’s authorization does not answer all four questions.
Build a model-specific evidence file
| Evidence | What to match |
|---|---|
| Product identity | Model, product reference, legal manufacturer and current labeling. |
| Marketing route | The applicable regulator record and exact cleared/authorized scope, where required. |
| Intended use | Population, setting, prescription/OTC route and limitations in the local label. |
| Responsible parties | Manufacturer, local representative, importer and distributor roles. |
| Validity and changes | Document date, current status, relevant expiry and version history. |
U.S. example: registration is not approval
The FDA establishment registration and device listing database expressly states that registration, a registration number and listing do not denote approval of an establishment or its products. Check the applicable marketing authorization route separately, including whether the exact model and intended use match.
The FDA’s import guidance explains that applicable U.S. requirements extend to foreign manufacturers and imported devices. Checks can include the legal marketing pathway, registration/listing, a U.S. agent where required, importer role and post-market duties. These are U.S. examples; other jurisdictions have their own requirements.
A document review should end with an explicit gap list
- Verified: record URL, identifier, model and reviewed date.
- Unclear: naming differences, untranslated label, missing appendix or unsupported intended use.
- Required next step: original document or regulator confirmation from the responsible party.
This checklist does not establish authorization for VivaChek CGM, GS1 or any supplier in a particular market. Do not turn a regional product page into regulatory clearance evidence.
Original sources
Sources reviewed 18 October 2026. Model features and local access should be checked against the current instructions and market record.