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  3. Medical: Instruments

製造販売業許可番号

13:20 Oct 30, 2009
Japanese to English translations [PRO]
Medical - Medical: Instruments / 眼科
Japanese term or phrase: 製造販売業許可番号
製造販売後安全管理基準なら「good vigilance practice（GVP）」という訳語があるのですが、「製造販売業許可番号」は見当たりません。
どなたかご存知の方がいらっしゃれば、お願いいたします。
ShigekoUematsu
Local time: 00:21


Summary of answers provided
3 +1marketing authorisation number
StanleyTanaka
3 +1manufacturing license number
matsuquin37
3 +1marketing authorization license number
Michael Karpa
4(Medical Equipment) Manufacturing & Selling Business License No.
Tokyo_Moscow
4Marketing Business License Number
Ramsyah Faizal
3License number of marketing authorization holder
Steven Smith


  

Answers


1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
marketing authorisation number


Explanation:
I found is also as MA Number

StanleyTanaka
Local time: 00:21
Specializes in field
Native speaker of: Bulgarian

Peer comments on this answer (and responses from the answerer)
agree  Joyce A: I found this term in the FDA regulatory guidelines. But with the american "Z" (authorization). :-)
9 hrs
  -> Thanks
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1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
manufacturing license number


Explanation:
I think it can be described quite simply; "manufacturing license number".

matsuquin37
Local time: 16:21
Native speaker of: Native in EnglishEnglish, Native in JapaneseJapanese

Peer comments on this answer (and responses from the answerer)
agree  Steven Smith: Of course!
5 mins
  -> Thank you!
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1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
marketing authorization license number


Explanation:
The attached document from the Ministry of Health, Labbor and Welfare gives this term as "license number", but the context is already clear. If the context is not clear, then perhaps "marketing authorization" should also be included.

Sorry if this repeats too much of the above, but they all sounded pretty convincing, so I wasn't sure who to agree with!


    Reference: http://www.ometa.or.jp/download/a1_1234.doc
Michael Karpa
United States
Local time: 08:21
Works in field
Native speaker of: English

Peer comments on this answer (and responses from the answerer)
agree  Raitei: It seems that the same term is used for both imported and domestic medical devices.
12 mins
neutral  Steven Smith: I'm pretty sure that the marketing authorisation is authorisation for a specific product, whereas the manufacturing license is held by the manufacturer for the general category of product they make.
6 hrs
  -> I'll defer to your wisdom on this. I'm far from sure. The reference document is pretty helpful, though.
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1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
(Medical Equipment) Manufacturing & Selling Business License No.


Explanation:
Manufacturing & Selling Business (of Medical Equipment) License No.

http://www.racoon.co.jp/english/company/index.html

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Note added at 1 hr (2009-10-30 14:52:34 GMT)
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There is a difference between 医療機器製造業許可 and 製造販売業許可.
Also, 製造販売業承認? 番号 doesn't seem to exist in medical appliance field.
Below is an example for 三田理化工業株式会社's licences :
薬事法： 高度管理医療機器等販売業・賃貸業　　許可番号　第N00007号
許可年月日　平成17年4月1日
第二種医療機器製造販売業　　許可番号　27B2X90001
#
http://www.racoon.co.jp/company/index.html
#
許可年月日　平成17年4月1日
医療機器製造業　　許可番号　28BZ200009
許可年月日　平成17年4月1日
医療機器修理業　　許可番号　27BS6191
許可年月日　平成17年2月18日
And the English translation of that seems to be quite reasonable:
Pharmaceutical Affairs Act
Selling / Lease Business of Advanced Control Medical Equipment: License No. N00007
License was granted on April 1, 2005.
Manufacturing & Selling Business of Second Class Medical Equipment: License No. 27B2X90001
License was granted on April 1, 2005.
Medical Equipment Manufacturing Business: License No. 28BZ200009
License was granted on April 1, 2005.
Medical Equipment Repair Business: License No. 27BS6191
License was granted on February 18, 2005.



    Reference: http://www.racoon.co.jp/english/company/index.html
Tokyo_Moscow
Japan
Local time: 00:21
Native speaker of: Native in RussianRussian
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5 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
Marketing Business License Number


Explanation:
Part VI Marketing Business License（製造販売業許可） Part VII Manufacturing Business License and Accreditation（製造業許可・認定） ...
http://www.jiho.co.jp/shop/goods/goods.asp?goods=40005

東京エム・アイ商会｜会社概要
第二種医療機器製造販売業許可番号：13B2X10072, License for marketing business of drugs ：13AY5112 2nd Class Medical Devices maketing business license ...
http://www.tokyo-mi.jp/company/index.html

Grant of Rx Drug and Non-Rx Drug Marketing Business License
Non-Rx Drug Marketing Business License in addition to its Rx Drug Marketing Business. License will make it possible for the company to broaden its services. ...
http://www.cmic.co.jp/e/topics/pdf/pr_sep_2006.pd



Ramsyah Faizal
Indonesia
Local time: 22:21
Specializes in field
Native speaker of: Native in IndonesianIndonesian, Native in SundaneseSundanese
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1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5
License number of marketing authorization holder


Explanation:
製造販売業者 is marketing authorisation/approval holder.
I think 製造販売業承認番号 is 'marketing authorisation number'　which identifies authorization to manufacture a particular product, but the manufacturer also needs a general license to manufacture, which defines the type of product manufactured. (I think!)

[PDF]
Handbook for Preparation of Summary Technical Documentation ...
...establishment, license number of the marketing authorization holder, approval number or certification number, brand name and product name in the section ...
www.pmda.go.jp/english/service/pdf/notifications/No.0216003...

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Note added at 1 hr (2009-10-30 14:35:24 GMT)
--------------------------------------------------

薬事法の第１２条の一項には製造販売業許可の種類が記載されています。 これは製造販売の承認と違う項目だと思います。

--------------------------------------------------
Note added at 8 hrs (2009-10-30 22:04:28 GMT)
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'Manufacturing License (Kyoka):
Companies that manufacture drugs or medical devices in Japan or at foreign facilities for import into Japan are required to obtain a manufacturing license for each such manufacturing location (termed an ‘accreditation’ for foreign facilities). For manufacturing facilities located in Japan, the manufacturing license is generally issued by the governor of the prefecture in which the manufacturing facility is located.
http://www.morganlewis.com/pubs/Overview_Pharma_device_reg.p...

Steven Smith
United Kingdom
Local time: 16:21
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 8
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