Global Market Access
TentaConsult Italia supports manufacturers, importers, and distributors of medical devices, IVDs, cosmetics, and biocidal products in managing the regulatory approvals, registrations, and compliance activities required to access international and non-EU markets.
Accessing global markets requires a structured regulatory strategy, specialized technical expertise, and a thorough understanding of the local regulatory frameworks applicable to medical devices, IVDs, cosmetics, and biocidal products.
Through a network of international partners and a practical regulatory approach, TentaConsult Italia assists companies in planning and managing the activities necessary to commercialize products worldwide while maintaining compliance with local requirements.
We support businesses with:
- Market authorization processes
- Registrations with local Competent Authorities and regulatory agencies
- Preparation and submission of regulatory applications and dossiers
- Import and export regulatory requirements
- Local representation services
- Post-market compliance activities
Our goal is to simplify international market access, helping companies reduce regulatory risks, avoid operational challenges, and accelerate the commercialization of their products in global markets.
Global Market Access Services
Regulatory Dossier Preparation and Submission
We support companies in preparing the technical and administrative documentation required by local regulatory authorities for product commercialization in international markets.
Our activities include:
- Collection and verification of regulatory documentation
- Development of the regulatory strategy
- Preparation of registration and authorization dossiers
- Management of regulatory submissions
- Follow-up with Competent Authorities and regulatory agencies
- Handling requests for additional information and documentation
Our approach is tailored to the target country, product classification, and applicable local regulatory requirements.
Manufacturing Site and Product Registration
Many international markets require the registration of both the manufacturer and the product before commercialization.
TentaConsult Italia supports companies with:
- Product registration
- Manufacturing site registration
- Device listing
- Establishment registration
- Local regulatory authority registrations
- Management of national regulatory platforms and submission portals
Authorized Representative and Device Initial Importer Services
In many non-EU markets, the appointment of a local Authorized Representative or registered importer is a mandatory regulatory requirement.
Through our international partner network, TentaConsult Italia supports companies with:
- Authorized Representative services
- UK Responsible Person (UKRP)
- Swiss Authorized Representative (CH-REP)
- US Agent services
- Local Sponsors
- Device Initial Importer support
Our services include operational coordination, documentation management, and regulatory oversight to ensure compliance with local market requirements.
Post-Market Surveillance (PMS)
Post-market activities are a fundamental regulatory requirement in many international jurisdictions and are essential for maintaining market authorizations.
We support companies in managing:
- International Post-Market Surveillance (PMS) activities
- Registration maintenance and renewals
- Annual reports and regulatory submissions
- Regulatory updates and change management
- Variations and amendment processes
- Ongoing compliance activities
Our objective is to help companies maintain uninterrupted market access and preserve the validity of existing registrations and approvals.
Importer and Distributor Regulatory Responsibilities
Importers and distributors play a critical role in maintaining regulatory compliance throughout the international supply chain.
TentaConsult Italia provides support for:
- Definition of regulatory responsibilities and obligations
- Verification of required documentation
- Distribution compliance management
- Traceability and supply chain requirements
- Import/export documentation management
- Compliance with local regulatory requirements
Countries and International Markets Supported
TentaConsult Italia, either directly or through its network of international regulatory partners, supports companies with regulatory and market access activities in more than 140 countries worldwide.
Our global market access services cover a wide range of jurisdictions and regulatory frameworks, helping manufacturers navigate local requirements efficiently and successfully bring their products to international markets.
Activities may include:
- Product registration with local Competent Authorities and regulatory agencies
- Appointment of Authorized Representatives and local regulatory contacts
- Management of regulatory submissions and approval processes
- Manufacturing site registration
- Importation and distribution compliance activities
- Post-Market Surveillance (PMS) requirements
- Maintenance and renewal of registrations and market authorizations
Technical and Regulatory Support for Medical Devices and IVDs
Global Market Access activities require multidisciplinary expertise that combines regulatory, documentation, clinical, and strategic competencies to successfully navigate international market requirements.
TentaConsult Italia supports companies operating in the following sectors:
- Medical devices
- In vitro diagnostic medical devices (IVDs)
- Medical software and Software as a Medical Device (SaMD)
Cosmetics - Biocidal products
- Healthcare and life sciences
Our Process
- Preliminary Project Assessment
Evaluation of the product, regulatory classification, and identification of the applicable requirements in the target market. - Regulatory Strategy Definition
Assessment of the market authorization pathway, required registrations, and regulatory activities necessary for commercialization. - Documentation Preparation
Collection, review, and organization of the technical and administrative documentation required by local regulatory authorities. - Submission Management
Operational coordination with local partners, Authorized Representatives, and Competent Authorities to support the submission and approval process. - Post-Market Support
Management of post-approval obligations, regulatory updates, registration maintenance, and ongoing compliance activities.
Looking to commercialize your products in international markets?
TentaConsult Italia supports manufacturers, importers, and distributors in managing regulatory registrations, market authorizations, and compliance activities for medical devices, IVDs, cosmetics, and biocidal products worldwide.
You may also be interested in
FAQ
What is Global Market Access for medical devices?
Global Market Access encompasses all regulatory activities required to commercialize medical devices and IVDs in international markets, including product registrations, regulatory approvals, local representation requirements, and post-market compliance obligations.
Is it necessary to register medical devices in non-EU countries?
Yes. Many countries require medical devices and IVDs to be registered with local Competent Authorities or regulatory agencies before they can be legally marketed.
What is an Authorized Representative?
An Authorized Representative is a local entity designated to act on behalf of a foreign manufacturer in dealings with the Competent Authorities of the target country, where required by local regulations.
When is a UK Responsible Person (UKRP) required?
A UK Responsible Person (UKRP) is required for manufacturers wishing to place medical devices on the Great Britain market following the UK's departure from the European Union.
What is the difference between FDA Registration and a 510(k)?
FDA Registration refers to the registration of the manufacturer, establishment, and device with the U.S. Food and Drug Administration (FDA). A 510(k) is a premarket submission demonstrating that a device is substantially equivalent to a legally marketed predicate device and is required for certain categories of medical devices before commercialization in the United States.
What is a Device Initial Importer?
A Device Initial Importer is the entity responsible for the first importation of a medical device into the United States and may have specific regulatory obligations under FDA requirements.
Are PMS activities required in international markets?
Yes. Many international jurisdictions require Post-Market Surveillance (PMS) activities, adverse event reporting, registration maintenance, and ongoing regulatory compliance after market authorization has been granted.
Is manufacturing site registration mandatory?
In some countries, yes. Local regulations may require the registration of the manufacturer and manufacturing facility before products can be placed on the market.
Does TentaConsult Italia support cosmetics and biocidal products?
Yes. TentaConsult Italia supports international regulatory projects involving medical devices, IVDs, cosmetics, and biocidal products, helping companies navigate country-specific regulatory requirements.
Is it possible to request a preliminary project assessment?
Yes. A preliminary assessment helps identify the most appropriate regulatory pathway based on the product type, classification, target market, and applicable regulatory requirements, allowing companies to plan their market access strategy effectively.