REGULATORY AFFAIRS OUTSOURCING

REGULATORY AFFAIRS OUTSOURCING

We want you to invest your time in what you like the most: generating income through the import and distribution of medical devices.

 

How to do it?

You buy and sell to the market that you know well and MDI Advisers is in charge of managing the regulatory affairs department for your company.
MDI Advisers looks at the needs of your company and puts at your service a department that will manage all regulatory matters in Spain and Portugal.
In order for a medical device to be marketed in Spain or Portugal, it is necessary to have previously obtained the CE marking with a Notified Body established in the EU and request its registration with the competent national authorities. Such as: Spanish Agency for Medicines and Health Products (AEMPS) in Spain or National Institute of Pharmacy and Medicine (INFARMED) in Portugal.

 

Who are our services for?

To any company or legal person who wishes to import, distribute or both at the same time, whether they have been doing it for a long time or intend to undertake a professional adventure in this field.


What are your commitments?

Provide us with faithful and truthful information about the products you want 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 make all the necessary arrangements with the Spanish and Portuguese health administrations so that the product has access to the market in the shortest possible time with full sanitary guarantees.

In order for MDI Advisers to be able to demonstrate 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 operated person. The greater the invasion in the human body, the greater its risk.

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

Four classes of risk:

CLASS I

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

CLASS I STERILE

They follow the previous norm, they are always for single use and they are presented in packages that guarantee sterilization. In this category we can find examination gloves, syringes or surgical instruments (only reusable case by previous sterilization after previous use).

CLASS I WITH EDITING FUNCTION

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

CLASS 2a

Included in this class are medical devices that are introduced into the human body through a body cavity or by surgical means (through the skin) but are not intended to remain inside 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 2b

In this class, the risk increases due to the greater potential of danger in its use inside the body for a period of time.
Examples: Intraocular lenses, blood bags, surgical lasers, among others.

CLASS 3

In this class we already talked about surgical implants for therapy or diagnosis. Some contain medicine.

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


CUSTOMIZED SANITARY PRODUCTS SUBGROUP

Medical devices that are implanted in the human body and generally produce an activity through an energy source (pacemakers or defibrillators).
These are intended for clinical investigations, self-diagnosis, “in vitro” diagnosis (IVD) and active implants.


What type of client may need our help?

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


What is a sanitary import license?

It is the one that authorizes the holder, for a specified period, to import certain health products from countries established outside the EU under the control of the Health Responsible Technician.

The Spanish Agency for Medicines and Health Products (AEMPS), under the Ministry of Health, is the body that grants these licenses in accordance with legislation for the import of health products.
The duration of the import license for medical devices is usually 5 years, after that time you must get a renewal.


How is a sanitary import license processed and obtained?

The import license is obtained after laborious work in which the requirements mentioned in the following point must be presented to the Spanish Agency for Medicines and Health Products (AEMPS), which reports to the Ministry of Health.
The usual period for processing and obtaining a license is established between three and six months, but may be longer.
Requirements:
• Present a technical report to the AEMPS in which it is demonstrated how current regulations regarding facilities, processes, certifications, etc. will be complied with.
• 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 a Responsible Health Technician who, among other obligations, will be in charge of releasing the imported and distributed batches. Without the authorization of the person in charge, the company will not be able to market the imported products.

Although the profile of the Guarantor Responsible Health Technician differs according to the Autonomous Communities, in general they can hold the post of a licensed staff or whose degree is reflected in the health professions law (medicine, pharmacy, dentistry, veterinary medicine or ophthalmology).
However, there are some restrictions in this regard: neither medical personnel nor dentists may exercise both technical responsibility and clinical practice. In some autonomies and only for the acceptance of distribution, not importation, specialists related to sanitary product manufacturing techniques are also accepted, such as chemical personnel, industrial engineer or biologist.


CAN I IMPORT SANITARY PRODUCTS WITHOUT LICENSE?

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

If you want to import cosmetics, perfumes or personal care products, you can do so by filing a responsible declaration.

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 class 2a, 2b or 3 medical devices or register in the Registry of Responsible Commissioners. The Market for class I products. For this, the following information must be available:

• Labelled.
• Instructions for use.
• CE marked.

MDI offers its clients experienced professionals :

• Obtaining a prior import license for medical devices.

• Communication of placing on the market and registration of managers at AEMPS.

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