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Medical Equipment

Agent Import of Class I and Class II Medical Devices

Medical Devices Exported to Japan: Necessary Certifications and Precautions

2024-10-31

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.

Certification Requirements and Procedures for Exporting Medical Devices to Australia

2024-10-31

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.

South Korea: Revises International Standards for Medical Device Exports

2024-10-31

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:

Certifications and Precautions for Medical Devices Exported to Malaysia

2024-10-30

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:

How to apply for the Medical Device Export Sales Certificate?

2024-10-30

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.

What certifications are required for medical devices exported to Russia?

2024-10-30

When exporting medical devices to the Russian market, understanding the relevant certification and market access requirements is crucial. Russian legislation and regulatory agencies for medical devices aim to ensure product safety and compliance. Below are the certification requirements to consider when exporting medical devices to Russia:

What are the procedures and formalities for importing medical devices?

2024-10-30

With the continuous development of medical technology, medical devices have become an indispensable part of modern healthcare. Many medical devices need to be imported from abroad, making it particularly important to understand the procedures and formalities for importing medical devices. In this article, we will introduce the definition, classification, and required import procedures for medical devices.

What Conditions are Required to Act as an Agent for Importing Dental Medical Devices?

2024-10-29

Importing dental medical equipment through agencies requires meeting specific conditions to ensure compliance with national regulations/quality standards and user safety/health protection.

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