我们提供瑞士授权代表服务（CH REP），以确保您的产品符合瑞士法规并成功进入瑞士市场。
这是指位于瑞士的自然人或法人接收并接受位于瑞士境外的制造商的书面授权，以代表制造商履行瑞士医疗器械法规规定的义务。因此，非瑞士制造商必须指定一名瑞士授权代表和一名瑞士进口商。
CMC Medical Devices GMBH 位于瑞士，拥有一支专业的法规团队，并可以担任瑞士授权代表。我们与瑞士药品监督管理局（SWISSMEDIC）和相关部门保持密切沟通与合作，能根据官方指示执行制造商的相应任务。
我们作为瑞士授权代表的职责
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验证合格声明和技术文件是否已准备好，如果适用，制造商是否已执行了适当的合格评定程序。
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向瑞士医疗机构首次注册我们的授权和gmdn。
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应主管部门的要求，在7天内提供所有必要的信息和文件来证明器械的合规性。
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向制造商转发来自主管部门的样品或访问设备的任何请求，并验证主管部门收到样品或有权访问设备。
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与主管部门合作采取任何预防或纠正措施，以消除或如果不可能，减轻设备带来的风险。
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根据制造商提供的信息向Swissmedic通知事故。
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根据瑞士当局或瑞士市场提供的信息向制造商通知事故。
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如果有特殊要求或问题，请联系制造商。
Frequently asked questions about TGA Registration
Manufacturers based outside the EU are legally obliged to appoint an Authorized Representative (EC REP) so that their products can legally circulate within the European Union market.
Regardless of whether a medical device requires the intervention of a Notified Body (in the case of Class I sterile/measuring/reusable, IIa, IIb and III) to obtain CE Marking, or whether the manufacturer can self-certify (Class I simple), those operating outside the EU must appoint an Authorized Representative so that their products can be placed on the European market.
The Authorized Representative plays a crucial role in ensuring device compliance, acting as the point of contact within the Union. The Authorized Representative’s minimum responsibilities include:
● Verifying that the technical documentation and other essential documents have been prepared and that the manufacturer has fulfilled its registration obligations.
● Providing the competent authority with all information and documentation necessary to demonstrate the conformity of a device.
● Transmit to the manufacturer any request from the competent authority to obtain samples of the device.
● Collaborate with the competent authorities in any preventive or corrective actions aimed at eliminating or mitigating risks that devices may present.
● Immediately inform the manufacturer of complaints and reports from healthcare professionals, patients and users about possible incidents related to a device for which they have been designated.
The European Authorized Representative (EC-REP or EAR) shares responsibility in case of defective products and is obliged to terminate the contract with the manufacturer if the manufacturer acts inconsistently with its obligations. Therefore, the EAR is responsible for defective products when the manufacturer has not fulfilled its obligations under the Medical Device Regulation (MDR).
Yes. Any manufacturer that is established outside the European Union is required to appoint an Authorized Representative (EC REP) based in the EU.
This requirement is essential for placing medical devices or IVDs on the market in accordance with Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).
Without a designated EC REP, it is not legally possible to access the European market.
Not always. In some cases, an importer or distributor can be designated as the Authorized Representative, but this must be done formally and in full compliance with legal requirements.
However, this practice may lead to conflicts of interest.
Therefore, it is recommended to choose an independent EC REP with expertise in regulatory compliance.
Yes. The name and address of the Authorized Representative must appear on the product labeling, the outer packaging, or the Instructions for Use (IFU).
In addition, the official EC REP symbol, as specified in ISO 15223-1, must be included.
This information must be clear, visible, and legible to meet the requirements of the MDR and IVDR.
Yes. It is possible to change your Authorized Representative at any time.
The current and new EC REPs must coordinate the transfer of responsibilities to maintain regulatory compliance.
The manufacturer must also update the labeling, technical documentation, and EUDAMED records, if applicable.
For medical devices and in-vitro diagnostic devices, EU Regulations (MDR and IVDR) mandate that non-EU manufacturers appoint an authorized representative based in the EU. This representative is crucial for ensuring compliance and acts as a primary contact point within the EU.
Since 2014, CMC Medical Devices has been dedicated to providing representation and consultancy services to manufacturers seeking entry into the EU market. Our headquarters, located in Spain, places us strategically to work closely with EU institutions. We are actively involved in European Commission Working Groups and Horizon Europe, the EU’s research and innovation program, shaping the compliance landscape over the years.
CMC Medical Devices is also a member of the European Association of Authorised Representatives (EAAR) and a founding member of the European Responsible Person Association (ERPA), both organizations committed to maintaining high standards of service and professionalism.
We highly recommend choosing a professional representative for your company within the EU. CMC Medical Devices offers:
● A team of experts to guide you through the compliance process
● Confidential handling of all shared information
● No conflict of interest, as we do not engage in manufacturing or selling products
● Up-to-date information on regulatory changes
Since our establishment, CMC Medical Devices has grown significantly and is a reference company in Europe for regulatory compliance. Our experts are well-equipped to help you navigate the EU, UK, and Swiss markets.
Why appoint CMC Medical Devices as your TGA Sponsor?
Fast response
We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.
Efficient communication
Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.
Immediate support
We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.
Quick resolution
Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.
