授权代表 | 法定代表

您在临床试验中的法定代表

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在临床试验中，我们可作为您的法定代表人，以确保试验的安全性、可信度，结果等。

临床试验的法定代表人

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临床研究是医学进步的一个重要方面，专注于疾病的研究和新医学治疗方法的开发。它涉及人类参与者，并受各种法律和道德法规的约束，以确保参与者的安全、权利和福祉。

确保这些标准的关键人物是法定代表人。他们的职能在临床研究中至关重要，承担着直接影响试验可信度和结果的重大责任。

CMC还可以作为您在 欧盟临床试验的法定代表 ，负责医疗器械和/或体外诊断设备的临床试验。

请填写联系表格，我们的顾问会尽快与您联系。

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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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