全球注册 | 沙特阿拉伯（KSA）

您在沙特阿拉伯的授权代表

我们简化了在沙特阿拉伯的全球注册流程，确保您的医疗器械产品符合法规，并为进入沙特市场提供高效的法律代理服务。

沙特阿拉伯授权代表

如果您在沙特阿拉伯没有办公室或实体，就必须指定一名沙特阿拉伯授权代表。

您的授权代表（AR）必须获得授权代表许可证，该许可证每年需更新，以便在沙特阿拉伯 (KSA) 代表您合法行事。

您的沙特阿拉伯（KSA）授权代表还负责向沙特阿拉伯食品药品监督管理局（SFDA）提交所有申请文件，以注册您的设备。沙特阿拉伯食品药品监督管理局（SFDA）规定了35个工作日为审核申请的官方期限；尽管实际审核时间往往会更长，尤其是在需要补充信息的情况下。

沙特阿拉伯食品药品监督管理局（SFDA）近期建立的路径要求进行技术档案评估 (TFA) 以获得上市许可，同时SFDA 也已实施了其自己的医疗设备分类制度。

在沙特阿拉伯 (KSA) 注册时，原产国的事先批准及参考国的批准并不是医疗设备注册 (MDMA) 的必要条件；然而，作为注册文件的一部分，仍然会要求提供在其他市场的任何现有批准证明。

CMC 可以通过在沙特阿拉伯食品药品监督管理局 (SFDA) 注册您的产品，帮助您进入阿拉伯市场。

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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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