Consulting Services
IDG helps you approach the medical device market with ease of mind. We assist you with Medical Device and IVD Registration, local in-country representation, distributor qualification and quality system compliance.
Details
IDG works close with business organizations of every type and size to identify their needs, opportunities to grow and market development options.
IDG offers your company the opportunity to do business in the medical device market in Latin America. IDG will provide your company with specialized advice and intelligent solutions for your business development and regulatory needs.
REGISTRATION APPROVAL
- Determine your medical device classification
- Prepare and submit registration documents
- Work to answer questions from the Country Regulatory Agency
- Act as your independent Registration Holder
REGULATORY CONSULTING
- IDG offers continuous assessment on regulatory compliance requirements based on each Country Regulatory Agency and regulations updates.
- Assessment and regulatory compliance based on ISO 13485. ANMAT, ANVISA, COFEPRIS e INVISA
IN COUNTRY REPRESENTATION
- If your company does not have a sales office or location in the country, you will need to appoint a Registration Holder as your in country representative. Relying upon distributors to coordinate the registration and approval of your medical devices, while convenient, it presents the problem that they have control over your device registration.
- You have the choice to change or appoint new distributors when you see it convenient.
DISTRIBUTION SERVICES
IDG aids in searching, evaluating, selecting and managing medical devices and IVD distributors. We assist in identifying the area the device specialized in, the service capabilities, reputation and geographic reach.
BUSINESS AND MARKET DEVELOPMENT
- Market studies
- Market positioning
- Distribution within country network
- Personnel outsourcing
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