How to choose a reliable denture export agency company? These 5 key questions must be understood!
May 29, 2025
I. What Makes a Professional and Reliable Denture Export Agency? Key qualifications to evaluate: Medical Device Business License: Must have Class II medical device export qualifications ISO 13485 Certification: Stricter quality system requirements under 2025 EU MDR FDA Registration: Essential for US market access Customs AEO...
Which agencies can handle the export of FDA-regulated items?
June 27, 2025
一、哪些機構(gòu)具備FDA產(chǎn)品出口代理資質(zhì)？ 根據(jù)2025年最新國際貿(mào)易規(guī)定，合法代理FDA認證產(chǎn)品的出口機構(gòu)需滿足以下條件： 基礎(chǔ)資質(zhì)： 持有商務(wù)部頒發(fā)的《進出口權(quán)許可證》 具備海關(guān)AEO高級認證資質(zhì) 在海關(guān)總署備案的進出口代理編碼 專業(yè)能...
Customs classification of hearing aids
March 4, 2024
In the bustling urban and quiet fields, people communicate with the world through hearing, enjoying the harmony of nature and humanity. However, for some hearing-impaired friends, the world may not be so complete. With the development of technology, a variety of hearing diagnostics and auxiliary devices such as spring rain-like lubricants have gradually improved their quality of life, making hearing...
A detailed explanation of the UAE medical device trade regulations
December 13, 2023
The United Arab Emirates (UAE), as the economic and financial center of the Middle East, is highly dependent on the import of medical devices. For companies that plan to export products to the Middle East Saudi region, getting acquainted with the UAE’s medical device trade regulations is a key step towards success. This article aims to comprehensively analyze the registration process and characteristics of UAE medical devices, as well as...
UKCA certification for medical devices exported to the UK
October 23, 2023
Since Brexit, medical device manufacturers have faced unprecedented legal challenges in selling their products in the UK market. New regulations and standards are constantly being introduced, most of which are the UKCA certification system. For this purpose, we provide you with a comprehensive guide to UKCA certification.
Detailed Guidelines for Exporting Medical Devices to the UK
October 20, 2023
The medical device industry continues to grow globally, especially in developed countries such as the UK. But for foreign manufacturers, entering the UK market requires a stringent set of regulations and processes. This article aims to provide a clear guide for those who intend to export medical device products to the UK market.
Analysis of the operation process of exporting medical devices to the US market
October 18, 2023
Entering the U.S. medical device market is a complex process involving many regulations and processes. But as long as companies strictly comply with FDA requirements and are well prepared, it is possible to succeed. Here are the detailed steps and precautions you may need to know about medical device exports to the U.S. market.
How to export medical device products to the European market
October 18, 2023
Medical device entering the European market is not simply selling products. Only in-depth understanding and following the regulatory requirements of the European Union can ensure success. However, need to meet a range of regulatory requirements of the European Union. This article will introduce you in detail to these processes and requirements.
Adjustment and impact of export quality supervision of epidemic prevention materials under the new situation
August 30, 2023
Since the outbreak of the new coronavirus in late 2019, public health has been severely affected worldwide. But now that the global health emergency has ended, our country has also incorporated prevention and control of the outbreak into normalized management. This shift not only means that social and economic activity will gradually return to normal, but also means that various policies and measures related to prevention and control of the outbreak need to progress accordingly.
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