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International market access

FDA

U.S. Food and Drug Administration (FDA) has the oldest law Federal Food, Drug, and Cosmetic Act (FD&C Act) back in 1938. Its legislative and standards are still state of the regulatory art in global compliance. The typical registration is 510k at FDA in US. Upon substantial change a new 510k is needed. The quality management 21 QSR 820 is aligning on international ISO 13485. To register medical device and IVD foreign manufacturer needs a US agent. 

 

We can offer the following services:

  • Free gap analysis from MDR to FDA (also from all other markets)

  • Premarket notification, 510k

  • 513g, determination of classification

  • Premarket approval

  • Establishment Registration and Device Listing

  • Edit of technical documentation

  • Change assessment

  • New QMSR transforming (21 CFR 820)

  • Validation support as usability

EU

We provide comprehensive proposal for successfully achieving MDR certification.

 

Our Team of seasoned experts can provide support in all the following activities and deliverables:

 

 

  • Technical Documentation as per Annex I, II and III of MDR

  • Risk management process as per ISO 14971

  • Usability process as per IEC 62366

  • Clinical Evaluation according to Meddev, MDCG and MDR

  • PMS, PMCF, SSCP, PSUR

  • Medical software as per IEC 62304

  • Device master record

  • Electronic IFU (e-IFU) smart solutions

  • Medical device development

  • MDSAP certification

  • ISO 13485 certification and audit support

  • IQ, OQ, PQ process validation

  • Design control process remediation

  • Person Responsible for Regulatory Compliance

International registration

We have international clients and network with international Partners too. Based on similar technical documentations we approach in multi-country lane. It is way easier to fit country specific requirements with help of intelligent document compilation. We support you also medical device registration in:

  

Canada

Straightforward with local representative

 

Japan

Communication is a barrier

 

Korea

Dealing with testing is the key

 

Taiwan

English documents are sufficient plus traditional Chinese of labelling

 

Australia/New Zealand

Unexpected fast if in EU is approved.

 

Brazil

Anvisa is basic, Inmetro getting easier, Anatal complex

 

Mexico

Authority starts to accelerate the review again.

Contact us as well for your regulatory affairs project. You can choose one of the best country specific personals either for the whole project or e.g. 20 hours per week or upon need with your regulatory partner.

 

We can work remotely and can come to your group in a regular basis in DACH region.

Authorised representative

EU authorised representative

 

European Authorized Representative works as a connection between your company and the relevant national Competent Authorities (Ministries of Health) to ensure your compliance in Europe. Moreover, selected representative will make sure following:

 

  • EUAR contributes with medical device registrations, as needed.

  • EUAR address needs to be placed on the device labeling

  • EUAR allows registration in EUDAMED of companies outside of Europe

  • EUAR have to maintain an updated copy of concerned Technical File or CE Declaration of Conformity accessible for inspection by a Competent Authority, as needed.

  • EUAR should support your company Vigilance activities with Incident and Field Safety Corrective Action (FSCA) reporting, in collaboration with the organization and its distributors

 

Swiss authorised representative

 

What can we do for You?

 

  • ensures Swiss market access as your Authorized Representative

  • offers to take the role as Person Responsible for Regulatory Compliance (PRRC) in Switzerland

  • supports you in fulfilling labelling requirements and registration procedures for the Swiss market

  • supports you in the handling of market feedback and your communication with CAs

  • cooperates with your regulatory affairs consultant

  • supports you to obtain the Swiss Unique Identification Number “CHRN”

 

UK responsible person

 

MHRA requires non-UK medical device manufacturers willing to market their devices in the UK to appoint a UK representative based in the UK.

 

Under MHRA, the UK REP has to serve the following roles:

 

• Ensuring the existence of the EU Declaration of Conformity (DOC) and technical documentation.

• Ensuring the availability of the documents as mentioned above and their certificates.

• Ensuring that the conformity assessment procedures are applied appropriately, and

• Cooperating with MHRA’s document requests

One example video of international registration

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