Classification and grouping assessment

Services

Veraque will be glad to help you on this first step to classify and group your medical devices. Our team has more than 10 years of experience and will treat all your requests with empathy.

We live your needs.

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When you are planning to export a medical device to other countries, a suggested first step is to evaluate the classification and grouping criteria for that specific country. This is because, once you know the classification and how you can group your products in one registration, you are able to understand more clearly and comprehensively what  is required. Otherwise, you can start with a wrong strategy and lose time. In Mexico, we have regulations based on the European and USA guides but they are not necessarily identical. Then, what is the best way to classify and group your family of products? 

 

Our experts have more than 10 years of experience in the medical device sector and are constantly evaluating the trends in classification and grouping criteria. This provides you with a solid first step for your regulatory affairs strategy. 

Whether you want to register by yourself or use a consulting firm, Veraque provides an excellent choice for this first step.

These are some of our key advantages for the classification and grouping assessment service:

Provide alternatives to group your products.

Prepare a report based on hundreds of previous evaluations.

The cost of this service is reimbursable for any consulting service you take with us related to the studied products.

We provide a 1 hour conference call after releasing the report to resolve any question you and your team may have.

At Veraque, we will be glad to evaluate all your products and provide a report. This report details not only the classification but alternatives for different groups. For example, you may want to group accessories within the same registration but it could be risky in case some of those accessories are considered medical devices alone. These are the types of details we provide in our report. We consider it an important tool for you since there is no single strategy to group and classify your products. That is where a second opinion makes sense.

Medical Devices

Classification

Grouping

    Class I low risk
    Class I
    Class II
    Class IIII

Make an educated assessment to decide how many products you can group in the same registration