CMC
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About us

CMC MEDICAL DEVICES & DRUGS, S.L. is a leading international consulting firm that specialize in regulatory affairs and focused on medical devices. Our headquarters in Spain allows us to operate from Europe to the rest of the world, we also have local representation in many other countries such as China, India, Argentina, USA, Brazil ... We represent companies around the world, being our priority results and customer´s satisfaction.

Our Mission

Help our customers overcome limits and cross borders.

Contribute to make the medical devices market more valuable and available.

 

Our Vision

Focus on needs of our clients: We provide customize services in order to achieve the best possible solution for every customer.

We achieve profitable growth for our clients by implementing diversified business models and opening markets.

To create value and make a difference.

Work efficiently and act with urgency.

CMC offers its clients comprehensive, flexible and cost effective solutions.

 

Our Value

 To be a company trusted by customers and society, a company fully responsible for its actions.

 

Member Of:

 

What makes us different?

 

 



EU REP

Where a manufacturer does not have a registered place of business in the European Community, he shall designate a single European Authorized Representative (EC REP) as required by Article 14.2* of Council Directive 93/42/EEC amended by Directive 2007/47/EC CMC is an authorized EC REP with offices in Spain. The definition of an authorised representative in Regulation 765/2008/EC stablish that: An “authorised representative” acts on behalf on the manufacturer in relation to specified tasks with regard to the latter's obligations under the relevant Community legislation.

 

Our duties as European Authorized Representative:

  • Registers your devices with the national Competent Authorities before they are marketed, where applicable.
  • Acts as your primary contact point for all national Competent Authorities.
  • Maintains a current copy of your Technical File available for inspection by the European Competent Authorities.
  • Gives you authorization to place our name and address on your device labels, packaging and Instructions for Use.
  • Always available to interact between you and the national Competent Authorities.
  • Responsible for Incident and Field Safety Corrective Action (FSCA) reporting to Competent Authorities, in cooperation with you and your distributors.
  • Protects the confidentiality of your documentation. The European Authorized Representative can only show technical documentation to Competent Authorities as required by law.
  • Monitoring changes to the regulations and communicate you only when is applicable.
  • Represents you to the European Commission for consultation in case of withdrawal of a medical device by a Member State(s).
  • Maintains reports concerning the critical evaluation of all data collected during clinical evaluations for review by Competent Authorities.
  • Notifies or is notified by the Competent Authorities of serious device incidents or FSCA.
  • Post-market surveillance

 

What makes us different?

  • Exclusivity: A customer - an agent. Each customer will be assigned a contact person, a single point of contact who will solve any management or doubt. Our customers have not to deal with different departments of the company (unless the customer requests it), a person will handle everything for you.
  • We have extensive experience representing hundreds of medical device companies worldwide.
  • Well-trained and qualified staff
  • Saving Costs and time
  • Time response: You will always receive a response from your agent in less than 24 hours.
  • Results oriented. Our goal is maximizing our customer satisfaction.

 

Cover countries:

Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Grece, Hungary, Ireland Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom, Iceland, Liechtenstein, Norway and Switzerland

 

 

 



Free sale Certificates

What is? Certificates of Free Sale or FSC, is an international document used to export medical devices and IVD products. It indicates that your products are marketed in Europe and can be freely sold with no limits to their exportation.
 

The FSC is required to export medical devices and IVD products in certain countries. This document acts as proof that your goods meet European regulations and are eligible for export. This certificate is used in the registration or renewal of the registration in non-European countries.

Not all FSC have the same acceptance rate by the competent authorities in some importing countries. Thus is important that your FSC is issued by a reference country. Spain is one of the so-called “reference countries” and all our certificates have been always admitted making new markets available to our customers

For further information, please contact us: info@cmcmedicaldevices.com





CE

JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

CMC will guide you through each of the steps necessary for obtaining CE marking.



Global Services



BLOG

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New medical devices rules approve

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FSC: Reference Countries

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Welcome to CMC



CONTACT

Do not hesitate to contact us for any questions, prices or timelines in the registration process.