SERVICES
Regulatory strategy
Experience doesn’t eliminate regulatory challenges—it teaches you how to overcome them. Regulatory success is rarely achieved by following a checklist. It requires experience, judgment, and the ability to adapt. Our structured approach helps manufacturers navigate complex regulatory environments with confidence, balancing compliance, timelines, and commercial priorities from day one.
Holder service
Protecting registrations. Preserving partnerships. Since 1980. Decades of experience, financial stability, and exclusive focus on medical devices provide manufacturers with confidence that their registrations remain protected throughout the product lifecycle.
Importer of Record
Know-How That Protects Your Investment.
Our team understands how Importer of Record decisions influence regulatory approvals, logistics, taxation, distribution, and long-term market access.
Compliance partner
Ongoing guidance for timely, business-oriented regulatory decisions across borders. Medisi America helps manufacturers, importers, distributors, and authorized representatives design, implement, and maintain quality and regulatory systems aligned with international and Mexican requirements. From ISO 13485 and NOM-241 implementation to warehouse compliance, NOM-240, training, internal audits, and operational execution, we become your long-term compliance partner.
CONTACT BY NEED
I’m an international manufacturer and I need product grouping and approvals.
Email Us
I own a branch in Mexico and need compliance guidance.
Email Us
Soy distribuidor y necesito registros y/o poner mi establecimiento en regla.
Email Us
Soy fabricante nacional y necesito NOM 241 / ISO 13485.
Email Us
我来自中国，需要在不同市场进行产品注册。
Email Us
REGULATORY FAQ
COFEPRIS registration for medical devices in Mexico requires product classification, technical documentation, local regulatory strategy, and coordination with an authorized local representative or Importer of Record when applicable.
An Importer of Record can support market access when a foreign manufacturer needs a compliant local structure for medical devices, customs coordination, post-market continuity, and long-term regulatory affairs execution.
Each authority has its own requirements, but a coordinated regulatory affairs strategy can help manufacturers prepare documentation, timelines, and market-entry decisions for Mexico, Colombia, Brazil, and other Latin American markets.
Classification determines the registration pathway, evidence requirements, review expectations, and approval timeline. Early classification work reduces rework and helps medical device registration move with fewer delays.
Yes. Manufacturers entering Mexico or Latin America often need local regulatory affairs support for medical device registration, documentation review, authority communication, and post-approval compliance.
Approval is only one step. Medical devices require ongoing regulatory affairs attention, including renewals, variations, importer coordination, quality-system alignment, labeling updates, and market surveillance obligations.