Services

These are the services that GTF can provide to your company: 

Cosmetics

 We are specialists in dermocosmetics. Ask us if you need help to comply with Regulation 1223/2009, European Portal, Security Report. Responsible statement

Medical Devices

We advise you to obtain the Authorization of facilities for  manufacturer / importer and the registration as a distribution company. We help you prepare the dossier to obtain the CE Marking.

National Parapharmacy Codes

We help you prepare the necessary documentation to obtain the National Code of Pharmacy (CN).

Food supplements and industry

In GTF we solve your paperwork related to food and food supplements. We make the revision of the labeling to adapt it to the regulations. We process the Communication of Food Supplements.

Biocides

We advise you to present your facilities and your biocidal products and disinfectants in the Official Registries of Public Health.

Biosanitary training

We carry out health courses in face-to-face, online and in-company mode. for technical and non-technical personnel, and adapting the training to your business needs.

Health establishments

 Ask us if you need help to get authorization from health facilities. We specialize in Opticians and Orthopedic Centers.

Quality systems

Do you want to implement ISO 13485, ISO 22716 or BPPC in your company? Check with our cabinet about quality systems and good manufacturing practices.

International service

M Camps GTF provide extensive Regulatory services to pharma / biotech companies setting up or expanding in the Americas and in Europe.

Do you need more information about our services?

Explain us a bit more about your company, your products and your regulatory needs, and we will help you find the best solution.

Single identification of the product: What will be possible with the new UDI system for Medical Devices?

In April 2013, the European Commission issued a recommendation concerning a common framework for a single identification system for medical devices in the EU. This was intended to lay the foundations for the EU's future identification and traceability infrastructure, in line with the latest developments worldwide.

Since then, the European Commission has promoted, through the publication of Article 26 of Regulation (EU) 2017/745 on Medical Devices, and Article 23 of Regulation (EU) 2017/746 on Medical Devices for In-Vitro Diagnostics, two essential initiatives aimed at providing coverage to the UDI system:

  1. The creation of the Medical Devices database Eudamed (whose name is an acronym for European Database on Medical Devices).
  2. The creation of the European Medical Device Nomenclature (EMDN) body, which provides support and facilitates the creation of the Eudamed database.

UDI: Identification that is primarily aimed at the safety of EU consumers

In short, the new Unique Device Identifier system – UDI will facilitate the traceability of medical devices.  In parallel, post-market activities relating to product safety will also be stronger and will allow better monitoring by the competent authorities.

In addition, the European Commission, using EMDN, has created a FAQ document relating to the Unique Device Identifier – UDI. Read her now!

Unique Device Identifier (UDI) in Medical Devices

Click at the link to visit the European Commission’s Unique Device Identifier – UDI website, where you will find all the information about the European Medical Device Nomenclature (EMDN) initiative and Eudamed, the new European Medical Device'sDatabase.

This web portal, created by the European Commission, is a space that will allow you to know, at first hand, all the official information from the health authorities in the euro area and all the new developments in relation to the new Unique Device Identifier - UDI and its implementation process.