Medical products require a different entry sequence from general consumer goods. Before signing exclusivity, foreign manufacturers should determine the applicable ANVISA category, responsible regulatory parties and real commercial decision path — with qualified specialists for regulated work.
What E2M would execute
- Segment hospitals, specialty clinics and distributor networks by product use
- Coordinate an initial regulatory responsibility map with qualified advisors
- Assess distributors’ product registration and channel experience
- Start account-level outreach only after commercial and compliance boundaries are clear
What to validate before committing
- Whether ANVISA registration or notification is applicable to the product
- Importer / registration-holder responsibilities and exclusivity
- Clinical evaluation, evidence requirements and purchasing committees
- Pricing, reimbursement, public versus private procurement
A practical 90-day sequence
Segment hospitals, specialty clinics and distributor networks by product use
Coordinate an initial regulatory responsibility map with qualified advisors
Start account-level outreach only after commercial and compliance boundaries are clear
Questions companies ask
Can E2M provide ANVISA approvals?
E2M is not a regulatory authority. We can coordinate entry planning and qualified specialized providers; approvals depend on the competent authority.
Will you guarantee hospital purchases?
No. We qualify relevant buyers and organize commercial execution, without guaranteeing orders.
Official references
Sector-specific guidance, not legal, tax or customs advice.