How to export medical device products to the European market
October 18, 2023
It provides a comprehensive guide for medical devices to enter the European market, from regulatory changes to technical document preparation, to the selection and registration of EU authorized representatives, and the introduction of ISO13485 standards.
Adjustment and impact of export quality supervision of epidemic prevention materials under the new situation
August 30, 2023
With the end of the global health emergency of the New Crown Epidemic and the normalization of epidemic prevention and control in China, the Ministry of Commerce (MOFCOM), the General Administration of Customs (GAC), the General Administration of Market Supervision (GAMS), and the State Administration of Pharmaceutical Affairs (SAMA) jointly issued new quality control measures for the export of epidemic-preventive materials. This article provides an in-depth analysis of the key elements of these new measures and their impact on exporters, as well as how to safeguard the international reputation of Chinese products.
Medical device import and management: detailed guidelines and key points
August 22, 2023
The importation of medical devices is a learning process, involving documents more complex than a human EKG and categorization and management more detailed than the diagnosis of a disease. Below, let us break down the A to Z of medical device importation to help you avoid hiccups in importation and ensure that you are on top of your game every step of the way!
Overview of the process and regulations for exporting medical devices to Japan
August 7, 2023
This article details the Yakusho Law, the main statute governing the management of pharmaceuticals and medical devices in Japan, as well as related implementing orders, announcements, and notices. Competent authorities include Japans Ministry of Health, Labor and Welfare (MHLW) and the administrative lawmaker Pharmaceuticals and Medical Devices Agency (PMDA). The article also details the rules for classifying medical devices, as well as the certification model and specific registration review of medical devices imported into Japan...
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