欧盟临床试验

我们协助您进行欧盟临床试验

联系

我们的欧盟临床试验(CRO)服务确保对您的临床试验进行全面有效的管理。

CRO服务包括哪些内容?

我们可以帮助你

临床评估是对医疗器械的最终验证，以确认其功能符合预期，并且可以根据其使用说明安全地由患者使用。

为了完全符合MDR 2017/745和IVDR 2017/746法规，重要的是要遵循ISO 20916:2019体外诊断设备和ISO 14155医疗设备中定义的要求。

它主要专注于临床研究服务，临床试验数据管理，包括统计分析，以及所有必要的数据来证明设备的安全性。

计划进入欧盟市场的欧盟以外的制造商必须按照新法规MDR 2017/745和IVDR 2017/746法规在欧洲进行临床试验。

CMC在医疗器械和IVD领域深耕了十年；我们的团队拥有超过15年的经验；我们专注于法规合规性；可以帮助您满足欧盟对临床评估性能研究的所有要求。

我们提供广泛的专业服务，协助医疗器械公司将新设备推向市场。

CMC可以根据最全面的监管指导文件为制造商设计符合标准的临床研究。

目前欧盟地区的临床指导文件如下:

ISO 14155-2020
MEDDEV 2.7/4
MEDDEV 2.7/2 Rev 2
MDCG 2021-20 MDCG

2021-08 MDR
ISO 20916:2019
MDCG 2021-2 – COVID-19

代理服务

CMC也可以成为您临床试验阶段的欧盟授权代表，用于医疗器械和/或体外诊断产品。

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后台栏目

摘要

Frequently asked questions about TGA Registration

Is the TGA sponsor responsible for the quality or safety of my products?

No, while the sponsor ensures that the products comply with Australian regulations and manages communication with the TGA, the foreign manufacturer is ultimately responsible for the quality and safety of their products.

Can my Australian distributor act as my TGA sponsor?

Yes, your distributor or any other individual/entity based in Australia can act as your TGA sponsor. However, it’s essential that they are qualified and willing to assume the regulatory responsibilities associated with this role.

How much does it cost to hire a TGA sponsor?

The cost varies depending on the sponsor’s services and the type of therapeutic goods being registered. It’s important to choose a reliable sponsor who can ensure compliance with TGA regulations.

What happens if I don’t have a TGA sponsor?

Without a TGA sponsor, your company cannot legally supply therapeutic goods in Australia. The sponsor is the official point of contact and is required for regulatory approval, ongoing compliance, and communication with the TGA.

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.

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