Strategy and regulatory intelligence: selection of best registration process, according to your needs, including equivalence agreements to registrations in other countries and/or third authorized parties in sanitary verification
Broad experience in obtaining registration for Classes IA, I, II, and III for:
Medical equipment
Temporal and permanent implants
Surgical instruments
In vivo or in vitro diagnostic agents (IVP)
Reagents
Combined products and accessories for use with medicines
Healing materials
Hygienic products
Odontology material and equipment
Post-marketing support:
Registration renewals (re-registration)
Variation or modification to registered conditions:
Naming or un-naming of distributors
Product updates
Change of manufacturer, etc.
Publicity campaigns
Compliance with technovigilance norm (see Technovigilance services) View more
Service of registration holder for medical devices View more
