西班牙 | 欧盟代表

您在欧洲的授权代表

联系

我们作为您在欧盟的授权代表，确保您的医疗器械符合所有欧洲法规，促进顺利有效的市场准入。

为CMC MEDICAL CONSULTING GROUP的总部，CMC DEVICES & DRUGS SL作为在欧盟没有注册办事处的制造商的“授权代表”，履行相关欧盟法律规定的具体义务。

CMC Medical Devices & Drugs S.L.是欧盟授权代表协会(EAAR)的成员，是欧盟授权代表公司之一，拥有广泛的全球客户群。

我们还可以作为您在欧盟的医疗器械和/或体外诊断器械临床试验的法定代表人。

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产品注册

我们的服务包括在将医疗器械和/或体外诊断产品投放市场之前向西班牙主管当局(AEMPS)进行注册。

一旦注册完成，制造商就可以将其产品出口到欧盟市场。

我们在欧盟注册您的产品

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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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