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  • 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

    自英國(guó)脫歐后,醫(yī)療器械制造商在英國(guó)市場(chǎng)上的產(chǎn)品銷售面臨了前所未有的法律挑戰(zhàn)。新的法規(guī)和標(biāo)準(zhǔn)不斷出臺(tái),其中最為核心的是UKCA認(rèn)證制度。為此,我們?yōu)槟峁┝薝KCA認(rèn)證的全面指南。 1、UKCA認(rèn)證簡(jiǎn)介 UKCA(英國(guó)符合性評(píng)定)標(biāo)志是英國(guó)醫(yī)療器...

  • Detailed Guidelines for Exporting Medical Devices to the UK

    October 20, 2023

    醫(yī)療器械行業(yè)在全球范圍內(nèi)持續(xù)增長(zhǎng),尤其是在英國(guó)這樣的發(fā)達(dá)國(guó)家。但對(duì)于外國(guó)制造商來說,進(jìn)入英國(guó)市場(chǎng)需要遵循一系列嚴(yán)格的規(guī)定和流程。本文旨在為有意向?yàn)獒t(yī)療器械產(chǎn)品出口英國(guó)市場(chǎng)的提供一個(gè)清晰的指南。 一、產(chǎn)品分類 判定產(chǎn)品分類是首要步驟...

  • Analysis of the operation process of exporting medical devices to the US market

    October 18, 2023

    進(jìn)入美國(guó)的醫(yī)療器械市場(chǎng)是一個(gè)復(fù)雜的過程,涉及許多法規(guī)和流程。但只要企業(yè)嚴(yán)格遵守FDA的要求,準(zhǔn)備充分,就有可能獲得成功。以下是您可能需要知道的關(guān)于醫(yī)療器械出口美國(guó)市場(chǎng)的詳細(xì)步驟和注意事項(xiàng)。 一、美國(guó)的醫(yī)療器械監(jiān)管機(jī)構(gòu) 在美國(guó),醫(yī)療...

  • How to export medical device products to the European market

    October 18, 2023

    醫(yī)療器械進(jìn)入歐洲市場(chǎng)并不是簡(jiǎn)單地銷售產(chǎn)品。只有深入了解和遵循歐盟的法規(guī)要求,才能確保成功。然而,企業(yè)需要滿足歐盟的一系列法規(guī)要求。本文將詳細(xì)為您介紹這些流程和要求。 一、了解歐盟的法規(guī)變動(dòng) 歐洲市場(chǎng)的醫(yī)療器械監(jiān)管經(jīng)歷了從MDD到MD...

  • 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

    醫(yī)療器械進(jìn)口是門學(xué)問,涉及的文件比人的心電圖還復(fù)雜,分類管理比診斷病癥還細(xì)致。下面,讓我們?yōu)槟馕鲠t(yī)療器械進(jìn)口的A到Z,幫助您避免進(jìn)口時(shí)的小插曲,確保每一步都步步為營(yíng)! 一、醫(yī)療器械進(jìn)口所需文件資料 進(jìn)行醫(yī)療器械的進(jìn)口,您需要準(zhǔn)備...

  • Overview of the process and regulations for exporting medical devices to Japan

    August 7, 2023

    一、法律法規(guī) 根據(jù)《Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices》(簡(jiǎn)稱:《藥機(jī)法》),日本藥品和醫(yī)療器械的管理遵循這一法規(guī)?!端帣C(jī)法》由原《藥事法》變更而來,其具體實(shí)施規(guī)...