Last reviewed: July 2026.
Qserve Group is a global medical-device consultancy known for EU MDR/IVDR strategy, notified-body preparation, clinical evaluation, US FDA submissions and quality systems. It's a strong fit for sponsors whose primary need is EU MDR/IVDR readiness or a broad global regulatory strategy. bioaccess® is purpose-built for a narrower job: LATAM medical device registration across 19 markets on published two-part pricing (one-time registration fee plus annual holder fee), with the registration held through our own in-country entities.
| Metric | bioaccess® | Qserve Group |
|---|---|---|
| Service focus | LATAM medical device registration + in-country registration holder / importer of record | Global full-lifecycle regulatory affairs consultancy — many regions, many services |
| Geographic scope | 19 Latin American & Caribbean markets (Colombia, Brazil, Mexico, Argentina, Chile, Peru, Panama, Ecuador, El Salvador, Dominican Republic) | Global multi-region — strong in US FDA, EU MDR/IVDR, UK, Canada, Australia, Japan, China and more |
| Pricing model | Published two-part pricing: one-time registration fee (initial government fees and certified translations included up to a stated cap) + annual holder fee from year 2; no multi-year contract | Category norm across global RA consultancies: registration fees, government/agency fees, translations, and registered-agent / authorized-representative services are typically quoted as separate line items |
| Published pricing | Registration $4,000–$22,250 one-time by country/class + holder fee $3,900–$7,500/yr from year 2 | Category-level: not publicly listed; usually a project quote plus recurring authorized-representative / holder fees |
| Additional registrations (same country) | Additional registrations, or models the agency requires to be filed separately, are quoted separately | Category-level: typically re-quoted per SKU family; specifics vary by shop |
| Registration holder / importer of record | bioaccess® is the contractual registration holder across 19 LATAM markets, working with our local partners in-country | Qserve Group operates under a global consultancy model; local registration-holder / authorized-representative services vary by country and are commonly outsourced or partnered |
| Regulatory anchoring | LATAM registrations built on FDA / Health Canada / CE-mark reliance pathways (e.g., COFEPRIS vía abreviada, INVIMA reliance) | Broad regulatory coverage worldwide — including original submissions in the US, EU and elsewhere |
Category-level, widely-known facts about Qserve Group as a global regulatory-affairs consultancy. Competitor pricing statements describe the general category norm, not a company-specific quote. Any comparative cost figures are based on quotes and published pricing for equivalent scope obtained as of July 2026; individual quotes vary by consultancy. bioaccess® figures reflect our published LATAM registration operating model.
Only in a narrow slice. Qserve Group is a large, reputable global regulatory-affairs consultancy serving customers across the US, EU and many other regions with the full regulatory lifecycle. bioaccess® is purpose-built for one job: medical device registration and in-country registration-holder / importer-of-record services across 19 Latin American & Caribbean markets. If you need a single global RA partner across many regions, Qserve Group is often the better fit. If your near-term milestone is LATAM registration with published two-part pricing per country, bioaccess® is purpose-built for it.
The annual holder fee per country and device family includes the government submission fees, certified or sworn translations where the agency requires them, the in-country registered agent, and the regulatory liaison. Electrical/EMC and RF homologation for wireless devices are handled through the country's telecom authority at vendor cost plus a 20% G&A handling fee.
Typical time-to-registration once the dossier is submitted: varies by study; we confirm per protocol for low-risk devices and a timeline that varies by study (we confirm it per protocol) for Class II/III — varying by country and classification, and excluding health-authority queries and audit scheduling outside our control. Indicative review windows vary by country and device class: INVIMA (Colombia) Class I/IIa automatic issuance, Class IIb/III full prior review within 90 business days once the file is complete (Decreto 582/2017 art. 1, https://normograma.invima.gov.co/normograma/compilacion/docs/decreto_0582_2017.htm); ANMAT (Argentina) imported Class I/II by sworn-declaration prior notice (Disp. 236/2026); locally made Class II reviewed in 15 business days (ANMAT Disp. 9688/2019, art. 5, https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-9688-2019-332646/texto) and Class III/IV in a 110-business-day review period (Disp. 9688/2019, arts. 5–6); COFEPRIS (Mexico) ~30-working-day processing target on the equivalence route (vía abreviada) for eligible devices and standard-route review times that vary by class (we confirm per protocol); ISP (Chile) (varies by study; we confirm per protocol) (experience-based); ANVISA (Brazil) notificação (Class I/II, effectively immediate on a valid submission) or registro, subject to statutory maximums of ~250 days (equipment), 320 (materials) or 365 (IVD).
Yes — this is a common pattern. Sponsors regularly use Qserve Group (or a similar global RA consultancy) for US FDA and EU MDR/IVDR work and pair that with bioaccess® for LATAM registration and in-country registration-holder services. Our documentation is designed to be portable and to reuse the FDA or CE technical file so the LATAM submission slots in cleanly.
Choose Qserve Group (or another global RA consultancy in its category) when your primary need is US FDA original submissions, EU MDR/IVDR with a notified body, MDSAP, or a single global RA partner spanning many regions beyond LATAM. bioaccess® is the right choice when LATAM registration in one or more of our 19 markets is the near-term milestone and you want published two-part pricing with the local entity accountability included.
LATAM Market Access hub · LATAM registration pricing · LATAM Importer of Record guide
Colombia (INVIMA) · Brazil (ANVISA) · Mexico (COFEPRIS) · Argentina (ANMAT) · Chile (ISP)