Pharmaceutical Affairs Law
The Regulatory System and Requirements in Japan for Medical Devices - The New Pharmaceutical Affairs Law -
1) English seminar text book is available here at 120 Euro or 15000 Japanese Yen
A sample (3 pages) of the text book
The flyer of "The New Pharmaceutical Affairs Law in Japan"
How to purchase?
If you use Microsoft Outlook as the e-mailing software,
Click here, open the "OFT" file and send an e-mail. or (if not), send an e-mail to "infoservice@tuv-sud.jp"
- Please include informaiton of a to e as shown below:
- We will send you an invoice first by Email.
- Please note that we accept payment by wire transfer ONLY.
- After confirming your remittance, we will send you the text books and a receipt within 10 business days. * Refund is excluded from this transaction.
- a. Number required:
- b. Your name :
- c. Company and dept (if applicable):
- d. Postal Address :
- e. Telephone No:
2) Download Regulatory Documentation related to the PAL !
MHLW issued several English translated documents related to the PAL requirements. You can download them from here free of charge.
1.Good Quality Control Practice for MAH
2.GMP requirements for Pharmaceuticals
3.QMS requirements for Medical Devices & IVD Reagents
4.Regulations for buildings and facilities
English translation of the PAL can be purchased at
YAKUJI-NIPPO LTD.
Important Notice to study the documents:
There is a typo found in the document #3 "QMS requirements".
The very last article, "Supplimentary provision, Article 4" of this document starts from the description "For 2 years of the date of enforcement ..." and then, listing up the article numbers which should be the subject of the
transitional period not to apply for 2 years. In the original Japanese text, at the end of this article, there is a sentence saying "may not be applied". However, this important sentence is found to be missing in the English translated version. Please read "Supplimentary provision, Article 4", adding "may not be applied" at the end.