CMC Medical Devices (UKRP)
CMC Medical Devices offers expert regulatory consulting and in-country representation for medical devices in the UK and globally. They ensure compliance and market access for manufacturers.
CMC Medical Devices (UKRP) is a specialized consultancy firm focused on regulatory affairs for medical devices, offering comprehensive services for international market access. Based in Spain, the company has established a significant presence with offices in the UK, Switzerland, USA, Australia, and China, enabling them to provide personalized regulatory solutions across diverse global markets. Their core offerings include in-country representation, such as UK Responsible Person (UKRP) services, European Authorized Representative (EC REP) services, and Swiss Authorized Representative (CH REP) services. These services are crucial for manufacturers outside these regions seeking to comply with local regulations and ensure their products can legally circulate in these markets. Beyond representation, CMC Medical Devices provides extensive consulting on regulatory compliance, including MDR, IVDR, ISO 13485, and EUDAMED registration. They assist with technical file preparation, quality management system establishment, and Free Sale Certificates, acting as a primary point of contact with local authorities to facilitate smooth communication and continuous compliance. Their expertise ensures that medical device manufacturers can navigate complex regulatory landscapes efficiently and successfully launch their products.
About
**Who they are**
CMC Medical Devices (UKRP) is a regulatory consulting firm specializing in in-country representation for medical devices, ensuring compliance and market access for manufacturers globally.
**Expertise & scope**
* Acts as the primary point of contact with local authorities in various regions.
* Facilitates the issuance of Free Sale Certificates.
* Provides comprehensive solutions to accelerate product approvals.
* Assists in preparing compliant technical documentation for MDR and IVDR.
* Offers representation services in the UK (UKRP), EU (EC REP), Switzerland (CH REP), Australia (TGA Sponsor), USA (FDA Agent), and China (NMPA Agent).
* Supports global registration processes.
**Reputation / proof points**
* CMC Medical Devices UK is a subsidiary of CMC Group, located in London, United Kingdom.
* CMC Medical Devices is a member of the European Association of Authorized Representatives (E.A.A.R).
* CMC Medical Devices UK is a member of the Association of Responsible Persons in the UK.
* CMC Medical Devices GmbH is located in Switzerland.
* CMC Medical Devices PTY LTD supports clients as a TGA sponsor in Australia.
* CMC Medical Devices Shanghai Co., Ltd. represents foreign manufacturers in China.
* CMC Medical Devices LLC has a team with extensive knowledge of FDA regulations.
CMC Medical Devices (UKRP) is a regulatory consulting firm specializing in in-country representation for medical devices, ensuring compliance and market access for manufacturers globally.
**Expertise & scope**
* Acts as the primary point of contact with local authorities in various regions.
* Facilitates the issuance of Free Sale Certificates.
* Provides comprehensive solutions to accelerate product approvals.
* Assists in preparing compliant technical documentation for MDR and IVDR.
* Offers representation services in the UK (UKRP), EU (EC REP), Switzerland (CH REP), Australia (TGA Sponsor), USA (FDA Agent), and China (NMPA Agent).
* Supports global registration processes.
**Reputation / proof points**
* CMC Medical Devices UK is a subsidiary of CMC Group, located in London, United Kingdom.
* CMC Medical Devices is a member of the European Association of Authorized Representatives (E.A.A.R).
* CMC Medical Devices UK is a member of the Association of Responsible Persons in the UK.
* CMC Medical Devices GmbH is located in Switzerland.
* CMC Medical Devices PTY LTD supports clients as a TGA sponsor in Australia.
* CMC Medical Devices Shanghai Co., Ltd. represents foreign manufacturers in China.
* CMC Medical Devices LLC has a team with extensive knowledge of FDA regulations.
Additional information
CMC Medical Devices emphasizes its role as a crucial intermediary between manufacturers and regulatory bodies. For instance, as an EC REP, they are mandated to hold technical documentation and present it to Competent Authorities when legally required, safeguarding manufacturer confidentiality. Similarly, their function as a UK Responsible Person involves addressing inquiries from UK authorities and regulatory bodies promptly. This localized presence and direct communication channel are vital for navigating complex regulatory landscapes and ensuring smooth market entry and ongoing compliance.
Key Highlights
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Offers UK Responsible Person (UKRP) services for medical devices and IVDs post-Brexit.
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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Provides EU Authorized Representative (EC REP) services, essential for medical devices and IVDs entering the EU market.
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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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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Serves as an FDA Agent 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.”
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Provides Representation services in China, acting as an Authorized Representative for NMPA registration.
Source
“CMC Medical Devices Shanghai Co., Ltd. can represent foreign manufacturers without branches in China as your Authorized Representative in China, to assist in completing the registration of imported medical products with the National Medical Products Administration of China...”
Certifications & Trust Signals
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CMC Medical Devices 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 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 seeking in-country representation for medical devices.
- Companies needing assistance with regulatory compliance in multiple global markets.
How engagement typically works
- Acts as a direct point of contact with authorities.
- Provides regulatory consulting and representation services.
- Facilitates product registration and market access.
Typical deliverables
- UK Responsible Person (UKRP) services
- EU Authorized Representative (EC REP) services
- TGA Sponsor services in Australia
- FDA Agent services in the USA
- China NMPA Agent services
- CH REP services in Switzerland
Good to know
- Best when manufacturers require a local legal entity or representative in target markets.
HQ:
Spain, ES
Languages:
English
Timezones:
Europe/London
Status:
listed
Services & Capabilities
Best UK Responsible Person (UKRP) | Compare & Get Quotes
Jurisdictions:
UK
Countries:
GB
Industries:
Medical devices, IVD, Healthcare
Portfolio:
6-25, 26-100
Onboarding time:
3–21 days
Pricing model:
Retainer
Starting from:
EUR 3,200
Included services:
UK Responsible Person (UKRP) designation, MHRA liaison and communications forwarding, Support for registration process readiness, Vigilance escalation workflows and FSCA coordination, Labeling check for UKRP identification
Supports GB:
Yes
Supports NI:
No
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
No
Vigilance Support:
Yes
Additional uk_rp Details
Device Classes Supported
All device classes supported as per regulatory requirements for each region.
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
Vigilance Support
Yes
Post Market Support
Yes
UK Entity Country
England
Onboarding Steps
Contact form submission to initiate engagement with a consultant.
