CMC
mute


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

 

 

 



UK RESPONSABLE PERSON

The transition period for the United Kingdom to leave the European Union is coming to an end on 31 December 2020. After this date UK will be considered a third country if no deal is reached.

It implies that if you are a manufacturer outside of UK, you need to appoint a UK Responsible Person when your products are placed on the UK market.

Our company with extensive experience in EC Rep services has expanded their officesto assist our clients also offering the service of UK responsible person.

The UK Responsible Person will act on behalf of the manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the
Great Britain market. UK Responsible Person will need to be included on product labelling.

All medical devices, including in vitro diagnostic medical devices need to be registered over the new basis, nonetheless the MHRA has established different grace periods depending on the product classification.

For more information, please don´t hesitate to contact us.



SWITZERLAND RESPONSABLE PERSON

Switzerland is not part of the European Union, but historically trade relations have been straightforward with multiple bilateral treaties and agreements.

However, this has recently changed. Switzerland and the EU have not renewed the mutual recognition agreement (MRA) governing CE marked products. This has implications for medical devices. From 26 May 2021, European manufacturers who want to place their medical devices on the Swiss market have to meet additional requirements: European manufacturers who want to place a medical device on the Swiss market have to appoint an Authorised Representative domiciled in Switzerland or CH-REP. The details of this representative in addition to the "CH-Rep" symbol must be included on the product labelling.

We at CMC have expanded our offices in order to be able to continue to support our customers in the Swiss market.

As CH-Rep, we will be the contact point for the Swiss authorities (Swissmedic). We will act on behalf of the manufacturer to carry out specific tasks in relation to thier obligations.

We put all our expertise at the disposal of our clients to guide them through this process.

The Swiss regulations have provided different deadlines for all actors to adapt to these changes.

CMC Medical Devices will help you to be ready so that you will not encounter any obstacles to market your products in Switzerland.

You can click on the map below for more information or you can also contact us. We will be happy to assist you.



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 we will guide you through the CE road map for medical and in vitro diagnostic devices under the new regulations (MDR 745/2017 & IVDR 746/2017) in order to affix the CE Mark on your device.



Global Services



BLOG

Read more

WHAT IS UNANNOUNCED AUDIT?

Read more

Indian’s new regulation for Medic

Read more

LIST OF NOTIFIED BODIES UNDER DIR

Read more

Which countries require CE markin

Read more

DO YOU WANT TO REGISTER YOUR PROD

Read more

Calling Indian manufacturers!

Read more

New regulation to be notes by Med

Read more

The FDA will help Combination Pro

Read more

WHAT TO INCLUDE IN YOU TECHNICAL

Read more

How to report serious incidents o

Read more

Types of reports for the implemen

Read more

Update in Post-Market Surveillanc

Read more

New medical devices rules approve

Read more

Guidance for clinical evaluation

Read more

Mutual recognition of evaluations

Read more

Japan’s PMDA is offering meetings

Read more

CFDA presents new classification

Read more

NEW FDA APPLICATION FEE FOR MEDIC

Read more

Significant points on how to comp

Read more

New MDR and IVDR requirements won

Read more

EXTENDED TIMELINE for MEDDEV 2.7/

Read more

MEDICAL DEVICES IN MALAYSIA SHOUL

Read more

How to prepare your Design Histor

Read more

NEW FDA registration page is avai

Read more

South Africa’s new regulation - S

Read more

FDA:Dates of compliance with UDI

Read more

New regulations in Vietnam: Regis

Read more

FSC: Reference Countries

Read more

Welcome to CMC



CONTACT

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