mhlw (japan's ministry of health labor and welfare)

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    Where to buy the latest MHLW, Canada MDR, Brazil medical device regulations

    Hello, Is there one website that I can get, buy, download the latest MHLW, Canada MDR, Brazil regulations for medical devices? Or if you have the sites you use for each one will be fine too. Thank you,
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    Japan's Definition of Should and Shall

    Does the definitions of should and shall mean the same for Japans MHLW and PMD Act requirements for medical devices as it does in ISO 13485:2016? Where can I find these definitions? :thanx:
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    Looking for English Copy of MHLW 169 regulation

    Hi All, I am looking for an English mapping of Chapter 2 the clauses against ISO 13485. Specifically I am looking for the Article numbers against the ISO clause. In the process of updating my QMS for MDSAP and the links appear to be broken that I have tried or are in Japanese only. Thanks in...
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    IVD Classification in Japan based on the Japanese Pharmaceutical Affairs Law

    Hi everyone, I would like to ask about the IVD classification system in Japan. I have read through a few sites and found out that the classification for IVD instrument and IVD reagent are categorized under two different systems (medical device & drug) based on the Japanese Pharmaceutical...
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    Source for The Enforcement Regulations in English - Article 228-20

    Through the good offices of several members of this forum, I was able to obtain an English translation of the 2014 revisions of MHLW Ministerial Ordinance No. 169. I hope you will be able to help me with my latest request. :rolleyes: Adverse event reporting is covered by Article 69 of MHLW...
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    Is MHLW Std No.169 - 2004 being Revised in Nov 2014?

    Hi all, I have just been informed that this Medical Device standard is being revised in Nov 2014 - has anyone else heard this? Also, if it is being revised I will be after an English Translation of the new standard, BSI don't do one and were not very helpful at all with my question. Anyone know...
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    Internet Medical Device Distribution applied to Internet/Catalog Shops

    Hi guys, we all know that medical device has to be registered with MHLW before it can legally sell in Japan, and that obviously apply to internet sales and catalog shop. But as medical device has to be sold at shops/agent with a medical device /pharmacy license, does that applied to...
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    Cross Reference Matrix for TGA and ANVISA requirements

    I have a cross reference matrix that I've been using to perform internal audits. It compares the following standards: 21CFR820, ISO 13485:2003, ISO 9001:2008, MDD (93/42/EEC), SOR/98-282, and MHLW. I need to add both TGA (Therapeutic Goods Administration) and ANIVSA (Brazil) to the matrix...
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    How can a Marketing Authorization Holder (MAH) be Licensed?

    Dear all, Any body familiar with the marketing authorization holder license? How can a marketing authorization holder be licensed? Does the license be granted by the MHLW or the PMDA or the local govenment? Is there any regulations or website recommended, both English and Japanese is OK...
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    Accreditation for Foreign Manufacture (MHW Ministerial Ordinance No. 2)

    We are a foreign manufacturer, and i want to know how to get the Accreditation for Manufacture? is a certificate issued? who will issue it? NOTE: MHW - Japan's Ministry of Health and Welfare -> Now MHLW (Ministry of Health, Labor and Welfare)
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