Regulatory Partners Switzerland
European Medicines Agency (EMA)
The European Medicines Agency (EMA) is a decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. It ensures that medicines available in the EU are safe, effective, and of high quality.
The European Medicines Agency (EMA) is the EU's agency for the evaluation of medicinal products. It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. The EMA's mission is to protect and promote public and animal health through the evaluation and supervision of medicines for use in the European Union. The agency is located in Amsterdam, the Netherlands, and operates with a commitment to transparency and scientific excellence. It plays a crucial role in advancing safe, ethical, and aligned AI practices across the medicines lifecycle and provides regulatory guidance. The EMA works closely with national regulatory authorities in EU Member States to ensure a harmonized approach to medicine regulation across the Union. It also engages with international partners to promote global standards for medicine quality, safety, and efficacy.
About
**Who they are**
Regulatory Partners Switzerland is a specialized firm focused on regulatory representation and compliance for medical devices and other regulated products within Switzerland. They act as the Swiss Authorized Representative, ensuring manufacturers meet local regulatory requirements.
**Expertise & scope**
* Serving as the legally mandated Swiss Authorized Representative.
* Facilitating market access for medical devices and other regulated products in Switzerland.
* Ensuring compliance with Swiss regulations, including those related to labeling and vigilance.
* Providing a local point of contact for Swiss authorities and the market.
**Reputation / proof points**
* Established presence in Switzerland to fulfill the role of Swiss Authorized Representative.
Regulatory Partners Switzerland is a specialized firm focused on regulatory representation and compliance for medical devices and other regulated products within Switzerland. They act as the Swiss Authorized Representative, ensuring manufacturers meet local regulatory requirements.
**Expertise & scope**
* Serving as the legally mandated Swiss Authorized Representative.
* Facilitating market access for medical devices and other regulated products in Switzerland.
* Ensuring compliance with Swiss regulations, including those related to labeling and vigilance.
* Providing a local point of contact for Swiss authorities and the market.
**Reputation / proof points**
* Established presence in Switzerland to fulfill the role of Swiss Authorized Representative.
Additional information
Engaging Regulatory Partners Switzerland as your Swiss Authorized Representative involves establishing a formal agreement to represent your company before Swiss regulatory authorities. They will manage ongoing compliance obligations, including vigilance reporting and ensuring your product labeling meets Swiss standards. This appointment is crucial for manufacturers seeking to place their devices on the Swiss market, as it designates a local entity responsible for regulatory adherence.
Key Highlights
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Acts as the Swiss Authorized Representative, a mandatory role for market access.
Source
“We act as your Swiss Authorized Representative”
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Ensures compliance with Swiss regulations for medical devices and other regulated products.
Source
“We ensure your compliance with Swiss regulations”
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Provides a local contact point for Swiss authorities and the market.
Source
“We are your local contact point in Switzerland”
Certifications & Trust Signals
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Specializes in Swiss regulatory representation.
Source
“Regulatory Partners Switzerland is a specialized firm”
Buyer Snapshot
Best for
- Manufacturers seeking Swiss Authorized Representation.
- Companies needing local compliance support in Switzerland.
How engagement typically works
- Formal appointment as Swiss Authorized Representative.
- Ongoing regulatory compliance management.
Typical deliverables
- Designation as Swiss Authorized Representative on product labeling.
- Vigilance reporting and communication with Swissmedic.
- Ensuring compliance with Swiss labeling requirements.
Good to know
- Best when manufacturers require a local Swiss entity to legally place products on the market.
HQ:
Amsterdam, NL
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:
6-25
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 2,000
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
Vigilance Contact Support:
Yes
Additional ch_rep Details
Device Classes Supported
All
Supports MDR
Yes
Supports IVDR
Yes
Swiss Entity Canton Or Region
Zurich
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
Onboarding Steps
Formal appointment as Swiss Authorized Representative, requiring an agreement and provision of necessary documentation to ensure compliance with Swiss regulations.
