CMC Medical Devices
CMC Medical Devices offers expert regulatory consulting and in-country representation for medical devices. They specialize in navigating global markets, ensuring compliance and facilitating market access for manufacturers.
CMC Medical Devices is a global regulatory consulting firm specializing in medical devices and in vitro diagnostics. With a strong presence in Spain and offices across the UK, Switzerland, China, Australia, and the USA, they provide personalized services to help manufacturers achieve regulatory compliance and market access in any country. Their services include in-country representation, acting as the primary point of contact with local authorities, and facilitating smooth communication. They also offer comprehensive consulting services, including assistance with Free Sale Certificates, acting as a Contract Research Organization (CRO) to accelerate product approvals, and establishing Quality Management Systems according to ISO 13485:2016. CMC Medical Devices is particularly adept at navigating complex regulatory landscapes, such as the Swissmedic requirements for systems and procedure packs, and the implementation of EU regulations in Switzerland. They specialize in acting as your representative in key negotiations and managing strategic relationships with stakeholders to facilitate business expansion.
About
**Who they are**
CMC Medical Devices is a regulatory consulting firm specializing in global market access for medical devices and in-vitro diagnostic devices. They offer expert representation and compliance services across various international markets.
**Expertise & scope**
* Acts as an authorized representative in multiple regions, serving as the primary point of contact with local authorities.
* Facilitates market access by ensuring compliance with regional regulations, including MDR and IVDR in the EU.
* Provides specific representation services for:
* European Authorized Representative (EC REP) based in Spain.
* UK Responsible Person (UKRP) with an entity in London.
* Swiss Authorized Representative (CH REP) with an entity in Switzerland.
* TGA Sponsor in Australia.
* FDA Agent in the United States.
* Assists with the issuance of Free Sale Certificates.
* Offers Consulting services for MDR, IVDR, ISO 13485, Manufacturing Licenses, Import Licenses, EUDAMED Registration, SWISSMED Registration, and GPSR.
* Supports global registration in regions including Europe, UK, Switzerland, Australia, USA, Southeast Asia, South America, Saudi Arabia, and Korea.
**Reputation / proof points**
* Member of the European Association of Authorized Representatives (E.A.A.R).
* Member of the Association of Responsible Persons in the UK.
* Maintains close communication and cooperation with authorities in the regions they operate.
CMC Medical Devices is a regulatory consulting firm specializing in global market access for medical devices and in-vitro diagnostic devices. They offer expert representation and compliance services across various international markets.
**Expertise & scope**
* Acts as an authorized representative in multiple regions, serving as the primary point of contact with local authorities.
* Facilitates market access by ensuring compliance with regional regulations, including MDR and IVDR in the EU.
* Provides specific representation services for:
* European Authorized Representative (EC REP) based in Spain.
* UK Responsible Person (UKRP) with an entity in London.
* Swiss Authorized Representative (CH REP) with an entity in Switzerland.
* TGA Sponsor in Australia.
* FDA Agent in the United States.
* Assists with the issuance of Free Sale Certificates.
* Offers Consulting services for MDR, IVDR, ISO 13485, Manufacturing Licenses, Import Licenses, EUDAMED Registration, SWISSMED Registration, and GPSR.
* Supports global registration in regions including Europe, UK, Switzerland, Australia, USA, Southeast Asia, South America, Saudi Arabia, and Korea.
**Reputation / proof points**
* Member of the European Association of Authorized Representatives (E.A.A.R).
* Member of the Association of Responsible Persons in the UK.
* Maintains close communication and cooperation with authorities in the regions they operate.
Additional information
CMC Medical Devices emphasizes its role as a direct point of contact with regulatory authorities, streamlining communication and ensuring continuous compliance for manufacturers. They highlight their ability to handle technical documentation and act on behalf of manufacturers for specific regulatory tasks. For manufacturers seeking to enter markets like the EU, UK, or Switzerland, appointing CMC as their representative is presented as a critical step to navigate complex regulations, especially given the divergence of Swiss regulations from EU MDR/IVDR. Their services extend to ensuring product labeling requirements are met, such as including the authorized representative's address on packaging where mandated.
Key Highlights
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Provides EU Authorized Representative (EC REP) services, acting as the primary contact with EU authorities for MDR and IVDR compliance.
Source
“For medical devices and in-vitro diagnostic devices, EU Regulations (MDR and IVDR) require that manufacturers outside the EU designate an european authorized representative based within the EU.”
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Offers UK Responsible Person (UKRP) services for medical devices and IVDs, ensuring compliance with post-Brexit UK regulations.
Source
“Since Brexit, manufacturers based outside the UK (including EU companies) are required to appoint a UK-based Responsible Person (UK RP) for their medical devices and in vitro diagnostic devices.”
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Specializes in Swiss Authorized Representative (CH REP) services, crucial for market access in Switzerland under its own Medical Device Regulations.
Source
“Since Switzerland and the European Union have not updated the Mutual Recognition Agreement in relation to the MDR and IVDR, manufacturers not based in Switzerland must appoint a Swiss-based Authorized Representative (CH-REP) to market their medical devices and in vitro diagnostic devices in the country.”
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Acts as a TGA Sponsor in Australia, facilitating medical device and IVD registration with the Therapeutic Goods Administration.
Source
“Manufacturers of medical devices and IVDs who are not based in Australia must select a representative in the country, known as an Australian Sponsor or TGA Sponsor.”
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Provides FDA Agent services in the United States for foreign manufacturers of medical devices and IVD products.
Source
“As a foreign manufacturer of medical devices and/or IVD products destined for the United States, you can ensure your path to success in the market by partnering with our exclusive FDA agent services in the USA.”
Certifications & Trust Signals
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Member of the European Association of Authorized Representatives (E.A.A.R).
Source
“CMC Medical Devices & Drugs SL, located in Spain, is a member of the European Association of Authorized Representatives (E.A.A.R).”
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Member of the Association of Responsible Persons in the UK.
Source
“As a member of the Association of Responsible Persons in the UK, it has a professional international regulatory team and is qualified to act as the legal entity for manufacturers outside the UK.”
Buyer Snapshot
Best for
- Manufacturers outside the EU/UK/Switzerland/USA/Australia seeking local representation.
- Companies needing assistance with MDR and IVDR compliance.
- Businesses requiring a dedicated point of contact with regulatory bodies.
How engagement typically works
- Acts as a direct liaison with authorities.
- Provides expert regulatory consulting.
- Facilitates market access and registration.
Typical deliverables
- Appointed Authorized Representative / Responsible Person / TGA Sponsor / FDA Agent.
- Regulatory compliance guidance.
- Assistance with device registration.
- Support for labeling and vigilance requirements.
Good to know
- Best when manufacturers require a formal, legally recognized representative in specific target markets.
- Requires clear product information and technical documentation for effective representation.
HQ:
Malaga, Spain
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim status:
Listed
Services & Capabilities
Find CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
26-100
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Swiss Local Contact:
Yes
Labeling Support:
Yes
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Swiss Entity Canton Or Region:
Switzerland
Additional ch_rep Details
Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
Requires designation of an authorized representative and importer in Switzerland; requires appointment of a UK-based Responsible Person; requires designation of an EU authorized representative based within the EU; requires selection of an Australian Sponsor.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Supports MDR
Yes
Supports IVDR
Yes
Swiss Entity Canton Or Region
Switzerland
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
Device Classes Supported
Class I, IIa, IIb, III (implied by MDR/IVDR support)
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