Medical Devices CH Rep
CMC Medical Devices GmbH
CMC Medical Devices GmbH is a leading consultancy providing in-country representation and global regulatory services for medical devices. They specialize in navigating Swissmedic regulations and ensuring market access.
CMC Medical Devices GmbH offers comprehensive regulatory and compliance services for medical device manufacturers seeking to enter and operate within the Swiss market. As an authorized representative (CH-REP), they act as the primary point of contact with Swiss authorities like Swissmedic, ensuring smooth communication and adherence to local regulations. Their expertise includes navigating the specific requirements for systems and procedure packs (SPPs) under the Medical Devices Ordinance (MedDO) and In Vitro Diagnostic Medical Devices Ordinance (IvDO). They assist with product registration, labeling, vigilance duties, and conformity assessments. CMC Medical Devices GmbH is committed to facilitating market access by providing personalized services that enable manufacturers to achieve regulatory compliance. They handle inquiries from authorities promptly and efficiently, minimizing delays and ensuring a smooth approval process for products entering Switzerland.
About
**Who they are**
Medical Devices CH Rep is a consultancy specializing in in-country representation and global regulatory services for medical devices, with a focus on navigating Swissmedic regulations. They are dedicated to ensuring market access for medical devices.
**Expertise & scope**
* Navigating Swissmedic regulations
* Ensuring market access for medical devices
* Providing in-country representation
* Offering global regulatory services
**Reputation / proof points**
* The Ch-Rep services of Elite Med Group have transitioned to ALTRION.
Medical Devices CH Rep is a consultancy specializing in in-country representation and global regulatory services for medical devices, with a focus on navigating Swissmedic regulations. They are dedicated to ensuring market access for medical devices.
**Expertise & scope**
* Navigating Swissmedic regulations
* Ensuring market access for medical devices
* Providing in-country representation
* Offering global regulatory services
**Reputation / proof points**
* The Ch-Rep services of Elite Med Group have transitioned to ALTRION.
Additional information
For inquiries regarding products and services, Elite Med Group emphasizes their availability to assist in selecting the best solutions for aesthetic medicine practices. They direct interested parties to contact them for more information, quotes, or to speak with an expert. It is noted that their Ch-Rep services have transitioned to ALTRION, with a redirection to a partner site for further engagement.
Key Highlights
-
Specializes in navigating Swissmedic regulations.
Source
“They specialize in navigating Swissmedic regulations and ensuring market access.”
-
Provides in-country representation and global regulatory services for medical devices.
Source
“CMC Medical Devices GmbH is a leading consultancy providing in-country representation and global regulatory services for medical devices.”
-
Ch-Rep services have transitioned to ALTRION.
Source
“The Ch-Rep services of Elite Med Group services have now transitioned to ALTRION.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking Swiss representation
- Companies needing to navigate Swissmedic regulations
How engagement typically works
- Direct contact for information and quotes
- Transitioned services now handled by ALTRION
Typical deliverables
- In-country representation
- Global regulatory services
- Market access support
Good to know
- Best when engaging with the successor entity, ALTRION, for Ch-Rep services.
HQ:
Switzerland, Switzerland
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical Devices, Pharmaceuticals, Biotech
Onboarding time:
7–21 days
Pricing model:
Custom pricing
Swiss Local Contact:
Yes
Labeling Support:
Yes
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Additional ch_rep Details
Supports MDR
false
Supports IVDR
false
Swiss Entity Canton Or Region
CH
Labeling Support
false
Swiss Local Contact
true
Vigilance Contact Support
false
Can Be Named On Label
false
