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Medical Device Registration Case Studies

How real registration outcomes become useful anonymized stories: each case combines a verified result with a disclosed, researched reconstruction of the problems and decisions along the way.

Case Studies
One Balloon-Catheter Line Through Two ANVISA Routes

A cardiovascular line split across ANVISA notification and Class IV registration, with the BGMP work scoped behind the coronary balloon.

One Contrast-Injection Catalog, Twenty-Four EUDAMED Device Groups

How a variant-heavy consumables catalog became 21 Class IIa and 3 Class IIb Basic UDI-DI groups, and the grouping criteria that decided it.

Class III Dermal Fillers: From Scope to PSUR Under the EU MDR

An aesthetic filler catalog inherits implant-grade duties: Annex XVI scope, Rule 8 classification, clinical evidence, SSCP and PSUR.

How a Single-Use Endoscopy Platform Became Six ANVISA Notifications

One platform, one planned filing — until grouping rules, intended purpose and the accessory boundary turned it into six Class II records.

Onboarding an EU Authorized Representative for a Surgical Robot

Article 11 verification, mixed Class IIa and Class I routes, EUDAMED registration and the artwork gate behind one AR mandate.

One Oncology Assay System, Several Regulatory Objects in Vietnam

One laboratory system crossed provincial and central workstreams, with separate central authorizations for the assay and its controls.

One IVD Reagent Menu, Sixteen COFEPRIS Registrations

Mexico registers determinations, not menus: how an ECLIA immunoassay menu became sixteen files across two risk classes.

A Sports-Medicine Fixation Line Into Colombia, in Neutral Hands

Why the manufacturer kept its INVIMA registration out of distributor ownership, with several importers operating beneath one holder.

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