Where was the Hasten Market Access — COFEPRIS-04-050 Registration study run?

The Hasten Market Access — COFEPRIS-04-050 Registration study was executed in Mexico by bioaccess® in the pain management / rehabilitation area.

What was the outcome of the Hasten study?

Reported outcomes for the Ampcare TENS Device: Master Services Agreement executed for multi-country LATAM regulatory framework; Work Order No. 1 (Mexico — Ampcare TENS device) launched under Tier 1 Market Access Essentials; Filing routed through COFEPRIS-04-050 abbreviated pathway (30 business-day review post-acceptance).

Hasten — COFEPRIS-04-050 Abbreviated Pathway: Ampcare TENS Device Registration in Mexico

Name: Hasten — COFEPRIS-04-050 Abbreviated Pathway: Ampcare TENS Device Registration in Mexico
Creator: bioaccess®

Hasten LLC — a Wyoming-based US commercial bridge that brings foreign medical-device manufacturers into Mexico — partnered with bioaccess® under a Master Services Agreement to register a TENS (transcutaneous electrical nerve stimulation) device manufactured by Ampcare LLC of Fort Worth, Texas. bioaccess® is delivering the engagement under its Tier 1 Market Access Essentials subscription via the COFEPRIS-04-050 abbreviated pathway, which provides a 30 business-day review window once the submission is accepted. The MSA framework is structured to scale across Latin America as Hasten's distribution portfolio grows.

Study facts

Sponsor / company: Hasten LLC
Device manufacturer: Ampcare LLC
Indication / area: Pain Management / Rehabilitation
Country: Mexico
Study type: Market Access — COFEPRIS-04-050 Registration
Device / product: Ampcare TENS Device (Transcutaneous Electrical Nerve Stimulation (TENS) Unit)
Regulatory pathway: COFEPRIS-04-050 — COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), Mexico (30 business days post-acceptance)

Key metrics

Pathway: COFEPRIS-04-050
Review Window: 30 biz days
Manufacturer: Ampcare LLC
Service: Tier 1 MAE

The challenge

Hasten acts as the US commercial bridge for foreign medical-device manufacturers entering Mexico — not the manufacturer itself. To bring Ampcare LLC's TENS device into Mexico (130M+ population, the second-largest medical device market in Latin America), Hasten needed a Mexico Registration Holder, COFEPRIS-04-050 abbreviated-pathway dossier preparation, certified Spanish translations, apostille handling, NOM-240-SSA1-2012 technovigilance compliance, and a vetted distributor channel — packaged as a single, predictable annual fee rather than a fragmented vendor stack, and on a framework that scales to additional LATAM countries without re-papering.

bioaccess® solution

bioaccess® executed a Master Services Agreement with Hasten and launched Work Order No. 1 for Mexico under its Tier 1 Market Access Essentials subscription (US$7,500/year per country, all-inclusive per MSA §6.2). bioaccess® is acting as Mexico Registration Holder (MRH) through its Mexican affiliate and is filing the Ampcare TENS device under COFEPRIS-04-050 — the abbreviated equivalence pathway that triggers a 30 business-day review window once the submission is accepted. The engagement bundles dossier preparation and submission, certified translations, notarization and apostille coordination, NOM-240-SSA1-2012 technovigilance, AI-powered Mexico market intelligence, and identification of 5–10 vetted distributors with warm introductions to the top three and 90 days of follow-up support. The MSA is built so additional countries (Colombia, Brazil, Argentina, Chile, Peru, Ecuador, Panama, Costa Rica, Dominican Republic) can be activated via a one-page Work Order.

Results

Master Services Agreement executed for multi-country LATAM regulatory framework
Work Order No. 1 (Mexico — Ampcare TENS device) launched under Tier 1 Market Access Essentials
Filing routed through COFEPRIS-04-050 abbreviated pathway (30 business-day review post-acceptance)
bioaccess® appointed as Mexico Registration Holder (MRH) for Hasten/Ampcare
All-inclusive annual subscription — single predictable fee per country (per MSA §6.2)
NOM-240-SSA1-2012 technovigilance and ongoing regulatory monitoring included
5–10 vetted Mexican distributors to be identified with warm intros to top 3
Framework ready for rapid expansion to 9 additional LATAM countries via one-page Work Orders

Frequently asked

What did bioaccess® do for Hasten?: bioaccess® executed a Master Services Agreement with Hasten and launched Work Order No. 1 for Mexico under its Tier 1 Market Access Essentials subscription (US$7,500/year per country, all-inclusive per MSA §6.2).
Where was the Hasten Market Access — COFEPRIS-04-050 Registration study run?: The Hasten Market Access — COFEPRIS-04-050 Registration study was executed in Mexico by bioaccess® in the pain management / rehabilitation area.
What was the outcome of the Hasten study?: Reported outcomes for the Ampcare TENS Device: Master Services Agreement executed for multi-country LATAM regulatory framework; Work Order No. 1 (Mexico — Ampcare TENS device) launched under Tier 1 Market Access Essentials; Filing routed through COFEPRIS-04-050 abbreviated pathway (30 business-day review post-acceptance).

Run a similar trial: Clinical trials in Mexico

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