To obtain the import license it is evident that, in addition to requesting it, a series of requirements must be met.
To meet the requirements to import medical devices into United States, among which are many of the biocides used in the official cleaning protocols for hospitality businesses, schools and offices, a series of duly covered documents must be presented and ensure that the facilities in which these sanitary products are going to be stored and used allow their correct use, in accordance with occupational safety and hygiene regulations.
It is necessary to have approved warehouses for these products, own or rented to a subcontractor, and the figure of the technician responsible for handling these Medical Device CE Marking is also necessary. If there are any, it must be indicated which companies other than ours would act as intermediaries in the import, storage or handling processes of the products.
The documents that must be provided to request a prior license are the following:
- application itself.
- Appointment of the technical manager.
- Organization chart.
- List of responsibilities of the technician and the rest of the staff.
- Contract of the technical manager.
- Qualification of the technical manager and other positions.
- List of products to be imported.
- Installation plan and location plan.
- Descriptive memory of the plan and the activities carried out.
- Environmental conditions in the different storage areas.
- List of subcontracted activities, contracts and corresponding information.
- Procedures.
- Content of the documentary file.
- Responsible for the surveillance system.
- Statement related to incompatibilities.
Fees.
Regarding the requirements of a business to store and use the imported products, assuming that a specialized company is not contracted for this task, the following must be provided:
- A plan of the facilities.
- The list of equipment and means available to carry out own activities and those that are subcontracted, with their location on the facilities plan.
- A list of the procedures for the development of the different activities and phases within the processes, again indicating the entities or companies that carry them out.
- How the activities are supervised by the technical manager, especially if we talk about subcontracted activities and timeshare technicians. Also, when the company requesting the license has facilities in different locations.
- A validation report that justifies the suitability of the equipment and processes, when applicable.
Why is the import license for medical devices necessary?
The requirements of the sanitary registry or sanitary license are many. A lot of documentation, and sometimes similar, but everything has a reason, and it is the protection of workers, users and the general public, and to guarantee traceability and correct labeling, which is not only required for food.
We know that businesses where food is served or handled must comply with strict regulations regarding safety and traceability. In the case of other companies, such as distributors, importers or manufacturers of medical devices, exactly the same thing happens, within their scope of regulation and it always improves the efficiency of the company.
The import license for medical devices is a requirement for many companies and, as has been seen, a tedious task at the bureaucratic level.
In addition, it is required to have approved warehouses and a technician responsible for medical devices on staff with Health training and proven experience.
For small importers or manufacturers, the simplest thing is usually to hire a company specialized in managing the health license.
If you need help, contact us and we will answer you in less than 24 business hours.
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