CryoConcepts, LP — COFEPRIS Registration & Regulatory Transition for Histafreezer® STAT in Mexico

CryoConcepts, LP, a U.S.-based leader in cryosurgical devices since 1991, partnered with bioaccess® to manage the COFEPRIS regulatory transition for their Histafreezer® STAT Portable Cryosurgical System in Mexico. The project involves an address change modification to their existing COFEPRIS registro sanitario, transitioning from their previous regulatory agent to bioaccess® as the new titular and regulatory representative. bioaccess® is handling the full administrative modification pathway, distributor setup, and regulatory compliance to ensure uninterrupted market access in Mexico — the second largest medical device market in Latin America with 130M+ population.

Study facts

• Sponsor / company: CryoConcepts, LP
• Indication / area: Dermatology / Cryosurgery
• Country: Mexico
• Study type: Market Access — COFEPRIS Registration

Key metrics

• Mexico Registration: COFEPRIS
• Product: Histafreezer® STAT
• Service: Reg. Transition
• Market: 130M+ pop.

The challenge

CryoConcepts needed to transition their existing COFEPRIS registro sanitario for the Histafreezer® STAT from their previous regulatory agent to a new titular and regulatory representative. The transition required navigating COFEPRIS's administrative modification pathway while ensuring zero interruption to their market access in Mexico — a critical market with 130M+ population and the second largest medical device market in Latin America.

bioaccess® solution

bioaccess® assumed full responsibility as the new titular and regulatory representative for the Histafreezer® STAT in Mexico. The team managed the complete COFEPRIS address change modification, coordinated distributor setup, and ensured regulatory compliance throughout the transition. bioaccess®'s deep familiarity with COFEPRIS administrative processes enabled a smooth handover from the previous agent with no disruption to CryoConcepts' commercial operations.

Results

• COFEPRIS registro sanitario transition managed from previous agent to bioaccess®
• Address change modification submitted through COFEPRIS administrative pathway
• bioaccess® appointed as new titular and regulatory representative in Mexico
• Distributor setup and regulatory compliance coordinated end-to-end
• Uninterrupted market access maintained for Histafreezer® STAT in Mexico

Frequently asked

What did bioaccess® do for CryoConcepts, LP?

bioaccess® assumed full responsibility as the new titular and regulatory representative for the Histafreezer® STAT in Mexico. The team managed the complete COFEPRIS address change modification, coordinated distributor setup, and ensured regulatory compliance throughout the transition.

Where was the CryoConcepts, LP Market Access — COFEPRIS Registration study run?

The CryoConcepts, LP Market Access — COFEPRIS Registration study was executed in Mexico by bioaccess® in the dermatology / cryosurgery area.

What was the outcome of the CryoConcepts, LP study?

Reported outcomes for CryoConcepts, LP's device: COFEPRIS registro sanitario transition managed from previous agent to bioaccess®; Address change modification submitted through COFEPRIS administrative pathway; bioaccess® appointed as new titular and regulatory representative in Mexico.

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