咨询 | IVDR

我们协助您准备技术文档

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我们的IVDR咨询服务确保您的体外诊断设备符合最严格的欧盟标准IVDR 2017/746。

欧盟体外诊断医疗器械法规(IVDR)

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IVDR的技术文档是必不可少的一部分，因为它包含有关体外诊断医疗设备(IVD)的信息的汇编。

它必须在整个产品生命周期中得到维护。在向欧洲市场引入体外诊断医疗器械时，制造商必须确保遵守体外诊断医疗器械(IVDR)法规(EU) 2017/746中概述的所有适用法规。

根据器械分类和选择的符合性评估方法，公告机构可能需要评估技术文档的一个或多个部分。

提交技术文件的指南符合体外诊断医疗器械(IVDR)法规的标准，详见法规(EU) 2017/746法规附则II和III。

CMC将根据新的IVDR 2017/746法规指导您完成体外诊断设备在CE认证中的各个步骤，直至为您的设备加贴CE标志。

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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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