Mexican Medical Device market is expected to reach $6.5 billion by 2020. Being the second largest market for medical devices in Latin America, Mexico offers a good bet of business opportunities. However, to market the devices in the region, manufacturers need to follow certain standards and procedures and should perform a clear-cut mapping of organizational goals and capabilities with that of Mexico’s regional Regulatory requirements. Manufacturers are required to have a comprehensive outlook on Mexican Medical Device Regulatory regime. It starts with decoding:
- Health Authority information (The Federal Committee for Protection from Sanitary Risks [COFEPRIS])
- Import permits
- Device classification system (Class I, II, or III)
- How to reach the market – is there any requirement for local representative?
- How and where to register the medical device? The application types, fees and documentation required
- What is the documentation for imported products? Certificate of free sale, Certificate of Good Manufacturing Practice issued by the health authority country of origin
- Health authority timelines to respond on applications submitted
- Labeling requirements for medical devices – general information and languages to be represented
Likewise, the process of Mexican medical device registrations and licensing includes many aspects that require your attention when entering the market. To give you a comprehensive overview, Freyr presents an exclusive webinar “Medical Device Registrations – A Global Perspective” – Part 1 MexicoonSep, 15th, 2017, 09.30 AM EST, Duration – 45 Min. Get your dose of information. Register your spot.