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, the most central of which is the UKCA certification (UK Conformity Assessed) system. To this end, we have provided a comprehensive guide to UKCA certification. 1. Introduction to UKCA Certification The UKCA (UK Conformity Assessed) mark is a British medical...
Detailed Guidelines for Exporting Medical Devices to the UK
October 20, 2023
The medical device industry continues to grow globally, especially in developed countries like the UK. However, for foreign manufacturers, entering the UK market requires compliance with a series of strict regulations and procedures. This article aims to provide a clear guide for those who intend to export medical device products to the UK market. I. Product Classification The first step is to determine the product classification...
Analysis of the operation process of exporting medical devices to the US market
October 18, 2023
Entering the US medical device market is a complex process involving many regulations and procedures. However, as long as companies strictly comply with the FDAs requirements and are well prepared, they have the potential to succeed. The following are the detailed steps and precautions you may need to know about exporting medical devices to the US market. I. US Medical Device Regulatory Agencies In the United States, medical...
How to export medical device products to the European market
October 18, 2023
Entering the European market for medical devices is not simply about selling products. Success can only be ensured by thoroughly understanding and complying with EU regulatory requirements. However, companies need to meet a series of EU regulatory requirements. This article will detail these processes and requirements for you. I. Understanding EU Regulatory Changes The regulation of medical devices in the European market has evolved from MDD to MDR...
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.
Medical device import and management: detailed guidelines and key points
August 22, 2023
Importing medical devices is a science, involving documents more complex than a human electrocardiogram, and classification management more detailed than diagnosing a disease. Below, let us analyze the A to Z of medical device imports for you, helping you avoid minor issues during import and ensuring that every step is taken with caution! I. Required Documents for Importing Medical Devices To import medical devices, you need to prepare...
Overview of the process and regulations for exporting medical devices to Japan
August 7, 2023
I. Laws and Regulations According to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (abbreviated as the Pharmaceutical and Medical Device Act), the management of pharmaceuticals and medical devices in Japan follows this regulation. The Pharmaceutical and Medical Device Act was changed from the original Pharmaceutical Affairs Act, and its specific implementation rules...
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