Agent Import of Class I and Class II Medical Devices
醫(yī)療器械行業(yè)是全球范圍內(nèi)的重要行業(yè)，其產(chǎn)品涵蓋了廣泛的醫(yī)療領(lǐng)域，包括診斷、治療、康復等。隨著全球化的推進，醫(yī)療器械的出口貿(mào)易日益頻繁，而歐盟作為全球最大的經(jīng)濟體之一，其市場對于醫(yī)療器械的需求巨大。然而，醫(yī)療器械出口歐盟需要滿足一系列的認證要求，這對于出口商來說是一項重要的任務(wù)。
在醫(yī)療器械出口到日本的過程中，制造商需要了解和遵守一系列復雜的規(guī)定和程序。本文旨在提供一個簡潔的指南，涵蓋了醫(yī)療器械在日本的立法和管理機構(gòu)、產(chǎn)品的定義和分類、市場準入流程、上市許可持有人管理、質(zhì)量體系、上市后的管理以及臨床試驗等方面。
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.
在出口醫(yī)療器械到俄羅斯市場時，了解相關(guān)的認證和市場準入要求至關(guān)重要。俄羅斯對醫(yī)療器械的立法和監(jiān)管機構(gòu)旨在確保產(chǎn)品的安全性和合規(guī)性。以下是在出口醫(yī)療器械到俄羅斯時需要考慮的認證要求：
隨著醫(yī)療技術(shù)的不斷發(fā)展，醫(yī)療器械已經(jīng)成為現(xiàn)代醫(yī)療中不可或缺的一部分。許多醫(yī)療器械需要從國外進口，因此了解醫(yī)療器械進口的流程和手續(xù)就顯得尤為重要。在本文中，我們將介紹醫(yī)療器械的定義、分類以及進口所需的手續(xù)。
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PSB Record: Shanghai No.31011502009912
