Registration Hosting – ANVISA

How to Ensure Cost Savings, Compliance, and Fast Market Entry in Brazil

For companies looking to introduce their products into the Brazilian market, ANVISA Registration Hosting is an effective and agile solution. ANVISA (National Health Surveillance Agency) is responsible for regulating and authorizing the commercialization of products such as medicines, medical devices, cosmetics, and others, ensuring they meet all safety and efficacy requirements. However, the registration process can be lengthy and complex, especially for international companies.

In this context, ANVISA Registration Hosting emerges as a strategic alternative for companies seeking to accelerate their entry into the Brazilian market without compromising compliance with ANVISA regulations.

What is ANVISA Registration Hosting?

ANVISA Registration Hosting is a solution that allows a company to host the registration, certification, or notification of its products under the name of an authorized company with the necessary ANVISA permissions. This means the company can begin selling its products immediately without undergoing the lengthy process of company regularization.

This strategy is particularly advantageous for companies that need fast access to the Brazilian market but do not want or cannot wait for the time required to establish a local entity.

Steps of ANVISA Registration Hosting

ANVISA Registration Hosting simplifies the regulatory process, allowing companies to operate in Brazil more efficiently. Here’s how it works:

1. Document Preparation
   The company must gather all necessary documentation, including safety, efficacy, and quality studies, along with other technical requirements, which will be submitted to the hosting company (such as Register Medical Group).
2. Submission for Hosting
   After preparation, the company sends the documents to the hosting company. The hosting company then submits the documentation to ANVISA, ensuring the product complies with all agency requirements.
3. Approval and Immediate Registration
   ANVISA reviews the registration request and, if all requirements are met, grants authorization (the actual registration) for the product to be commercialized.
4. Renewal and Updates
   The registration hosting can be renewed indefinitely, depending on the client’s needs. The hosting company is also responsible for updating and renewing the registrations with ANVISA.

Advantages of ANVISA Registration Hosting

ANVISA Registration Hosting offers several benefits for companies looking to enter the Brazilian market quickly:

1. Time Reduction
   Normally, the company and product registration process with ANVISA can take 12 to 24 months, depending on the company’s size and location. With registration hosting, the product can be registered immediately, avoiding long waiting periods for company regularization.
2. Cost Reduction
   ANVISA Registration Hosting eliminates the need to establish a local company and register it with regulatory bodies, reducing costs related to staff, office setup, and hiring a technical responsible person. Additionally, companies avoid expenses associated with health authority registrations.
3. Access to the Brazilian Market
   With the registration hosted by an authorized company, businesses can sell their products in Brazil, one of Latin America’s largest healthcare markets, with immediate access to consumers and national distributors.

ANVISA Registration Hosting vs. Partnerships with Local Distributors

A common alternative for foreign companies entering the Brazilian market is to establish exclusive relationships with local distributors to register products with ANVISA. However, this strategy can lead to challenges such as contractual disputes and financial constraints, impacting competitiveness and registration control.

ANVISA Registration Hosting solves these issues by providing greater control over registrations while maintaining company autonomy from local distributors. This approach also allows businesses to adjust their market strategy as needed.

With registration hosting, companies can authorize multiple distributors instead of being restricted to a single representative/distributor in the country.

Why Choose Register Medical Group for ANVISA Registration Hosting?

Register Medical Group specializes in ANVISA registration hosting, offering fast and secure solutions for international companies looking to register their products in Brazil. With a team of regulatory specialists, we ensure that the hosting process is carried out efficiently and in compliance with ANVISA requirements.

Benefits of Working with Register Medical Group:

✔ Expert consultancy throughout the entire registration hosting process.
✔ Access to the lowest ANVISA fees. Since most ANVISA fees are determined based on the company’s economic size, even if the manufacturer is a large company abroad, the legal nature of the RMG Group subsidiary responsible for registration hosting guarantees access to the lowest market fees.
✔ Complete management of the hosting process, from document preparation to registration approval.
✔ Legally and financially secure registration hosting, ensuring compliance with Brazilian regulations.
✔ Ongoing support during the registration validity period, including renewals and regulatory updates.

Ensuring a Fast and Secure Entry into the Brazilian Market

If you want to accelerate your product’s entry into the Brazilian market while ensuring compliance with ANVISA requirements, ANVISA Registration Hosting is the ideal solution. Register Medical Group provides the expertise needed to streamline this process, giving your company quick and secure market access without the challenges of setting up a local entity.