Services

Sanitary Registry Holder

NUEL gives you commercial security so you can implement the business strategies that best suit you.

Mexico´s sanitary registration process, is intended to ensure the integrity and functionality of health supplies. The government department responsible for monitoring the registration of medical devices is COFEPRIS (Federal Commission for Protection against Health Risks).

NUEL ENTERPRISES has the necessary experience in medical devices and drugs as well as in activities for standardization under criteria of the wide variety of products included in the medical technology sector in Mexico or territory of your interest, and also the ability to meet strict functions to represent your business before this commission. Our staff is fully qualified to collect, organize and submit documents to obtain medical records and work to resolve inquiries from COFEPRIS with regard to the registration during evaluation period.

Having the authorized representation of your products with a specialized agency, offers multiple benefits at the moment to penetrate a specific market or even if you already participate in one, as well as the representation holder of Sanitary Registry.

Some of the advantages that you obtain by making us your Authorized Representative:

• The information required to obtain the sanitary registry is confidential therefore it is important to give it to a specialized third party without commercial interests of the product. This enables you to have control over your product avoiding being affected by interests from third parties.
• The handling of the information by a regulatory agency that has knowledge on these matters means advantages for the approval and securing of the sanitary registry. We count on a vast legal and regulatory knowledge, hence it favors the response time and approval.
• Knowledge of regulatory affairs for the selected territory, It is important to remember that the regulation varies from country to country, and approval processes require a specific study.
• Constant update on the legal and regulatory framework for each territory enables us to keep validity and appropriate update of your products, this grants you an edge over your competitors, besides we look for the best strategy possible as to avoid delay on the approval.
• Among many other advantages, the Authorized Representative Service for sanitary registry implies investing in the business strategy that suits you.