REGULATORY AFFAIRS MEDICAL DEVICES

Our goal is for you to spend your time generating revenue through import and distribution while MDI handles regulatory affairs.

MDI Advisers studies the needs of your company and puts at your service a department that will manage all regulatory matters in Spain and Portugal.

For a medical device to be marketed in Spain or Portugal, it is necessary to have the CE marking with a Notified Body established in the EU and request its registration from the competent national authorities. This is: Spanish Agency for Medicines and Health Products (AEMPS) in Spain or Instituto Nacional da Farmacia e do Medicamento (INFARMED) in Portugal.

 

Who are our services aimed at?

We add value to distribution and import companies with and without a warehouse that commercialize or want to commercialize finished products that have all the necessary certificates for their placing on the market and especially the CE marking.

 

What are your commitments?

Provide us with faithful and truthful information about the products you wish to market in Spain and Portugal, as well as the documentation that supports the quality and safety of said products.

 

What is MDI Advisers committed to? 

To carry out all the necessary procedures with the Spanish and Portuguese health administrations so that the product has access to the market in the shortest possible time with full health guarantees.
•  To carry out the procedures aimed at obtaining import license.
•  To develop, implement and monitor the surveillance system:

°  Carry out the internal audits that the system indicates and that of your supplier companies.
°  Manage claims, withdrawals, no-conformities, etc.
° Prepare an annual plan for the training periods, providing initial and ongoing training to company personnel involved in product quality processes, as well as training new employees.

In order for MDI Advisers to conclude that a product can be marketed, it must be safe, effective and of quality. For this reason, it is very important to take into account the classification of medical devices based on the degree of invasiveness on the person. The greater the invasion into the human body, the greater is the risk clasification.

MDI puts at your disposal specialists in the matter who will act as interlocutor personnel before the health authorities, carrying out the administrative procedures necessary to obtain import licenses and the communication of the placing on the market of medical devices.

We found four classes of risk:

 

CLASS I

Products that only come into contact with the patient topically or through a natural orifice such as the nose and mouth for a limited time.

CLASS I STERILE

They follow the previous rule, are always single use and come in containers that guarantee sterilization. In this category we can find examination gloves, syringes or surgical instruments (the only case reusable by prior sterilization after previous use).

CLASS I WITH EDIT FUNCTION

The previous rule continues to be applied, presenting these the variety of their use. For example: non-electronic thermometers or tonometer’s.

CLASS IIa

SIncluded in this class are medical devices that are introduced into the human body through a body orifice or by surgical means (through the skin) but are not intended to remain within the patient. Likewise, we will include in this class those that supply energy or substances or those that modify physiological processes.
Examples: probes, cannulas, catheters, surgical gloves, among others.
 

CLASS IIb

EIn this class, the risk increases due to the greater potential for danger in its use or remain inside the body for a long time.
Examples: intraocular lenses, blood bags, surgical lasers, among others.

CLASS III

In this class we already mentioned surgical implants for therapy or diagnosis. Some contain drug.

Examples: Heart valves, implantable prostheses, condoms with spermicide, among others.

  

SUBGROUP OF CUSTOM MADE MEDICAL DEVICES

SThey are medical devices that are implanted in the human body and produce an activity generally through an energy source (pacemakers or defibrillators).


These are intended for clinical research, self-diagnosis, “In vitro” diagnosis (IVD) and active implants.

 

¿What is an import license for health products?

It is a license that authorizes the holder, for a specified period, to import certain medical devices from countries outside the EU under the control of the Responsible Technician.

The Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, is the body that grants these licenses to comply with the legislation for the import of health products.

The duration of the license for the importation of medical devices is 5 years, after which it must be renewed if you want to continue importing.

  

How is an import license for medical devices processed and obtained?

The import license is obtained after laborious work in which the requirements mentioned in the following point must be submitted to the Spanish Agency for Medicines and Health Products (AEMPS), which depends on the Ministry of Health.

The usual period for processing and obtaining a license is established between three and six months, but it can be longer.

Requires:

Submit a technical report to the AEMPS in which it is demonstrated how the current regulations will be complied with in terms of facilities, processes, certifications, etc.
Have warehouses approved by the AEMPS, either owned or subcontracted. The size of the warehouse will depend on the activity of the company and the type of product.
Have responsible technical personnel who, among other obligations, will be in charge of releasing imported and distributed batches. Without the authorization of the responsible technical staff, the company will not be able to market imported products.
An efficient quality assurance system that covers aspects such as claims management, withdrawals, product safety surveillance in the market, traceability, etc.

 

Can I import medical devices without a license?

Sometimes the AEMPS authorizes the importation of a product to companies that have an import license for the same product in process.

Once the authorization has been obtained (generally more than six months, but never less than three), you must notify the AEMPS of the placing on the market of medical devices Class IIa, IIb or III or register in the Responsible for Placing Class I Products on the Market Registry. For this, you must have, among other information,:

•  Labelled.

•  Instructions for use.

CE marking.