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 in-country representation for medical devices, ensuring compliance and facilitating market access for manufacturers globally. They offer expert navigation of international regulatory landscapes.
**Expertise & scope**
* Acts as authorized representatives in various regions, serving as the primary point of contact with local authorities.
* Provides representation services for the EU (EC REP), UK (UK RP), Switzerland (CH REP), Australia (TGA Sponsor), and the USA (FDA Agent).
* Assists with Free Sale Certificates and product registration in international markets.
* Offers Consulting services for MDR, IVDR, ISO 13485, and EUDAMED Registration.
* Specializes in navigating global registration processes across Europe, UK, Switzerland, Australia, USA, China, Saudi Arabia, Korea, and India.
* Provides support for Cosmetics, PPE, and acts as a Legal Representative.
**Reputation / proof points**
* CMC Medical Devices & Drugs SL is a member of the European Association of Authorized Representatives (E.A.A.R).
* CMC Medical Devices UK is a subsidiary of CMC Group and a member of the Association of Responsible Persons in the UK.
* CMC Medical Devices GmbH acts as an authorized representative in Switzerland and cooperates with SWISSMEDIC.
* CMC Medical Devices PTY LTD supports clients as a TGA sponsor in Australia.
* CMC MEDICAL DEVICES LLC has a team with extensive knowledge of FDA regulations.
CMC Medical Devices is a regulatory consulting firm specializing in in-country representation for medical devices, ensuring compliance and facilitating market access for manufacturers globally. They offer expert navigation of international regulatory landscapes.
**Expertise & scope**
* Acts as authorized representatives in various regions, serving as the primary point of contact with local authorities.
* Provides representation services for the EU (EC REP), UK (UK RP), Switzerland (CH REP), Australia (TGA Sponsor), and the USA (FDA Agent).
* Assists with Free Sale Certificates and product registration in international markets.
* Offers Consulting services for MDR, IVDR, ISO 13485, and EUDAMED Registration.
* Specializes in navigating global registration processes across Europe, UK, Switzerland, Australia, USA, China, Saudi Arabia, Korea, and India.
* Provides support for Cosmetics, PPE, and acts as a Legal Representative.
**Reputation / proof points**
* CMC Medical Devices & Drugs SL is a member of the European Association of Authorized Representatives (E.A.A.R).
* CMC Medical Devices UK is a subsidiary of CMC Group and a member of the Association of Responsible Persons in the UK.
* CMC Medical Devices GmbH acts as an authorized representative in Switzerland and cooperates with SWISSMEDIC.
* CMC Medical Devices PTY LTD supports clients as a TGA sponsor in Australia.
* CMC MEDICAL DEVICES LLC has a team with extensive knowledge of FDA regulations.
Additional information
CMC Medical Devices emphasizes its role as a direct point of contact with regulatory authorities in each region they cover. For European representation, they highlight that the EC REP must be based within the EU/EEA and their address may need to appear on labeling. Similarly, for the UK, the UK Responsible Person must be based in the United Kingdom. In Switzerland, a CH REP established in Switzerland is required. For Australia, the TGA Sponsor acts as a liaison with the Therapeutic Goods Administration. In the USA, the FDA Agent facilitates communication with the FDA for foreign manufacturers. They also provide insights into specific regulatory updates, such as the Swissmedic information sheet on systems and procedure packs, detailing obligations for economic operators including CH-REPs.
Key Highlights
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Offers comprehensive representation services including EU REP, UK RP, CH REP, TGA Sponsor (Australia), and FDA Agent (USA).
Source
“RepresentationEU REPUK REPCH REPTGA SponsorFDA AgentChina REP”
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Specializes in navigating global registration and compliance for medical devices and IVDs.
Source
“Comprehensive Regulatory and Compliance Services for Global Presence”
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Provides expert consulting on MDR, IVDR, ISO 13485, and EUDAMED Registration.
Source
“ConsultingMDRIVDRISO 13485EUDAMED Registration”
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Acts as the primary point of contact with local authorities, ensuring smooth communication and continuous regulatory compliance.
Source
“As authorized representatives in each region, we act as your primary point of contact with local authorities, ensuring smooth communication and continuous regulatory compliance.”
Certifications & Trust Signals
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CMC Medical Devices & Drugs SL is a 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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CMC Medical Devices UK is a subsidiary of CMC Group and a member of the Association of Responsible Persons in the UK.
Source
“CMC Medical Devices UK is a subsidiary of CMC Group, located in London, United Kingdom. As a member of the Association of Responsible Persons in the UK...”
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The company provides insights into Swissmedic regulations and obligations for economic operators.
Source
“Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.”
Buyer Snapshot
Best for
- Manufacturers seeking in-country representation for market access
- Companies needing assistance with MDR/IVDR compliance
- Businesses requiring regulatory support in multiple global markets
How engagement typically works
- Acts as a direct point of contact with authorities
- Provides regulatory consulting and representation
- Facilitates market access and compliance
Typical deliverables
- Designated EU Authorized Representative (EC REP)
- Designated UK Responsible Person (UK RP)
- Designated Swiss Authorized Representative (CH REP)
- Designated TGA Sponsor (Australia)
- Designated FDA Agent (USA)
- Regulatory consulting reports
Good to know
- Best when requiring representation in specific regions like EU, UK, CH, AU, US
- Requires manufacturers outside the respective regions to appoint a local representative
HQ:
Malaga, Spain
Languages:
English, German, French
Timezones:
Europe/Zurich
Status:
listed
Services & Capabilities
Best 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
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
Contact form submission to initiate engagement.
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)
