Agent Import of Class I and Class II Medical Devices
The market access process for medical devices in South Korea is relatively complex, involving multiple steps and the participation of multiple departments. This article will briefly introduce the certification and registration processes required for exporting medical devices to South Korea.
Full Analysis of Standards for Lighting Exports to Russia
The medical device industry is a vital sector globally, covering a wide range of medical fields including diagnosis, treatment, and rehabilitation. With the advancement of globalization, the export trade of medical devices has become increasingly frequent. The EU, as one of the worlds largest economies, has a huge demand for medical devices. However, exporting medical devices to the EU requires compliance with a series of certification requirements, which is a significant task for exporters.
When exporting medical devices to Japan, manufacturers need to understand and comply with a series of complex regulations and procedures. This article provides a concise guide covering Japans medical device legislation and regulatory authorities, product definitions and classifications, market access procedures, marketing authorization holder management, quality systems, post-market surveillance, and clinical trials.
Australia has a mature and large - scale public and private healthcare system, and the demand for medical devices is also very strong. However, to sell, import, or export medical devices in Australia, it is necessary to complete the registration review and obtain an access certificate in accordance with relevant regulations. This article will introduce this process in detail.
On May 12, 2023, the Ministry of Food and Drug Safety (MFDS) of South Korea issued a notice to make some revisions to the Medical Device Manufacturing and Quality Control Standards to make it more in line with international standards. The main contents of the revisions include:
October 30, 2024, 14:15
Exporting medical devices to Malaysia requires meeting some specific certifications and requirements. The following are the certifications and precautions for exporting medical devices to Malaysia:
The Medical Device Product Export Sales Certificate is an approval document issued by the Drug Administration according to the application of enterprises within its jurisdiction for enterprises that meet the requirements. This certificate aims to facilitate the export of medical device products within its jurisdiction and is an important service item. The following will introduce the handling process and relevant precautions of the Medical Device Export Sales Certificate.
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