We support more than 250 customers worldwide in regulatory issues in connection with medical devices.

We will find dependable, individual and useful solutions for your request.

Do you have any questions? Please get in touch with us...

GMP, QM & Regulatory Affairs Consulting

Our core competence lies on medical engineering

Our core competence lies on medical engineering.

Since 1994 we support manufacturers and distributors of medical devices to fulfill regulatory requirements established with European Medical Device Directive 93/42 EEC on June 14, 1993. We conduct regular FDA mock audits, prepare companies for FDA inspections, attend inspections as moderator and coordinate subsequent measures with the company if desired by our clients.

We offer our clients dependable, serious and practical services, e.g. in order to build up, maintain or complete adapted quality systems for the company. We consider the respective requirements, which the company has to implement due to its activities - among other things:

GMP, Quality Management

  • FDA, Title 21 CFR Part 820 (GMP requirements)
  • ISO 13485, ISO 9001
  • Guideline 93/42 EEC about medical devices
  • ANVISA Good Manufacturing Practice & Controls RDC16/2013
  • Canadian Medical Device Regulation (CMDCAS)
  • Japanese Pharmaceutical Law (JPAL), Ordinance No.169
  • Process and software validation
  • etc.

Regulatory Affairs

We assist clients in the compilation of technical dossiers for the admission of medical devices to put them into circulation at European and international markets:

Standard Technical Documentation (STED) for submissions in

  • USA: FDA 510(k) Premarket Submissions, PMA Premarket Notifications
  • Europe
  • Canada
  • Brazil

STEDs are completed with national requirements of the respective region / country.


U.S. Agent "Food and drug Modernization act" we accomplish that for you

Section 417 of the "Food and Drug Modernization Act" of the year 1997 (FDAMA) demands that each company has to be registered with FDA in connection with production, processing, advertisement, fitting or adaptation of medicine or medical devices, which are imported in the United States and they have to indicate

  • the name and address of the company and
  • the name of the United States Agent

The FDA published the "Final Regulation" on November 27, 2001 that implemented the requirements  (Federal Register, Vol. 66).
The date of commencement of this determination was on February 11, 2002.

Each company has to inform the FDA about the name, address and telephone number of their United States Agent for their medical devices. The determination (21 CFR 807.40) indicates, that each foreign company is allowed to name only one United States Agent, who either is located in the USA or the place of business resides in the USA. The foreign company can appoint its United States Agent as "Official Correspondent", but it isn't a must.


Brazilian license holder "ANVISA" we accomplish that for you

Since 2014 we have an own company in Brazil and we operate as an "Brazil License Holder" there.

Admission procedure in Brazil in general:

  • Manufacturer of medical devices, who wants to put products into circulation in Brazil, has to be registered with ANVISA
  • Manufacturer has to appoint a trade partner in Brazil (Brazilian Importer), who will be appointed on the products as "Legal and Technical Responsible"
  • Brazilian Importer = license holder


European representativeFor producer of medical devices with registered office outside of Europe

We offer a service of European Authorized Representative for manufacturer of medical devices with registered office outside of Europe.

Hereby we take care of companies during the admission and registration of their medical devices and keep in touch with the appropriate authorities and notified bodies. If you are interested in this service, we will generate an adapted offer for your company and your products.

Logistic Hub

Germany · USA · BrazilProvision of logistical services

Our primary focus lies on the consultation for issues of GMP and Regulatory Affairs requirements. Due to our international direction we have our own companies in the USA and Brazil, beside the main location in Germany. Therefore we are able to offer logistical services in the respective regions. Hereby we open the possibility for our clients to have their own store in respective countries and to provide products quickly and uncomplicated to clients. Reshipments can be collected and consolidated beside storage and distribution.

Clients can optimize their international appearance by using MEDAGENT as well-known and reliable service provider as contractual partner.



Griesweg 47
D-78570 Mühlheim
Tel.: +49.7463.9954.0
Fax: +49.7463.9954.10
E-mail: info(at)medagent.de


Pease International Tradeport
112 Corporate Drive, Unit 1
Portsmouth, NH 03801, USA
Tel.: +1.603.570.2039
Fax: +1.603.570.2055
E-mail: mail(at)medagent-usa.com

MEDAGENT do brazil ltda.

Av. Francisco Chagas de Oliviera, 1100
Sao Jose Do Rio Preto - SP
CEP 15090-190, BRAZIL