ISO 13485 vs. Japan's Pharmaceutical Affairs Law (JPAL)

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Bridget

#1
Hi all, I hope someone can help me iunderstand what a customer is requesting of me. I received a fax today with the following request-this company is in Japan and purchases finished goods from us. I think they want us to supply them with test results for each lot sent but ???

"Test on the products being imported from you has been implemented based on the testing method described in the written acknowledgement for which we applied to the Ministry of Health, Labor and Welfare.
In the new medical law, the test method will be changed as follows-your company (thats me) shall implement tests conforming to ISO 13485-2003 (regarding test items, our method having been implemented will be allowed), and the result of the test shall be attached by the lot in each export."

Ok, the way I understand this is puzzling, I do not recall specific test methods within 13485 or have I missed something?They states they will send the testing method to me after they translate it. Does anyone have any ideas to share about this?
Thanks,
Bridget
 
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celeo

#2
PAL Pharmaceutical Affairs Law

I lived and worked for a EU registrar based in Tokyo for a couple of years and did not get to understand the rationale why some things were done the way they are with regards to medical device approvals. However Japan is a member of the GHTF and has taken giant steps forward in achieving harmonisation of medical regulatory requirements. The implementation of Pharmaceutical Affairs Law is a vast improvement :tg: and is based on GHTF recommendations published on the ghtf.org website.
As far as testing th ISO13485 this is a bit of a misnomer. The attached gives some clues about PAL however come back to me if you need more particular help.
 

Attachments

B

Bridget

#3
Thanks

Hi Celeo,
I imagine there will be a lot of different approaches to this new law. We have several customers in Japan who resell our devices and I do not look forward to the extra work this may cause because each company will probably handle it differently. It took me two years of working with one company to get two products approved by the Japanese Ministry.

At least since they are basing it on 13485 I will know some of what they are trying to do. They have promised me an English version of the test methods they want so if I learn anything else I will post it for others.
Wish me luck,
Bridget
 
R

Rachel

#4
I know nothing about this...

...but from my chemical background, it sounds like they want a certificate of analysis, sort of??? Details of contents to follow? Maybe it won't be that bad.

Well, best of luck with that, anyway...
-R.
 
B

Bridget

#6
new law

Thanks Al,
I had already found this article. I am waiting to hear back from my customer tomorrow or Wednesday. I asked them what they mean in regards to the testing and I will post what I hear on the forum. I may have further questions later.
Bridget
 
L

legalrights

#7
Re: ISO 13485 vs. Japan's Pharmacutical Affairs Law

Through the 1990s, the application of a quality system relied primarily upon the Food and Drug Administrations’ (FDA) good manufacturing practice requirements or the FDA 21 CFR Part 820 Quality System Regulation. At that time, the international standards for quality management systems (QMS) were ISO 9001, ISO 9002, or ISO 9003, depending upon the scope of the organization’s quality system. Fast forward to 2009 and in the medical devices manufacturing industry, we now rely primarily upon ISO 13485 and the FDA Part 820 Quality System Regulation (QSR) to assure compliance. ISO 13485 and the quality system regulation are the de facto standards utilized by medical device and in vitro diagnostic companies for compliance with QMS requirements. There are other regulatory standards that may be specific to regions or countries that must be reviewed separately for organizations specific needs.
In this article, we will discuss how to utilize these standards for assuring harmonized compliance and assist in marketing devices around the world. We will focus primarily on ISO 13485—"Medical devices—Quality management system—Requirements for regulatory purposes," and how this international standard is utilized for meeting global regulatory requirements.
The first question that most organizations ask is, "Do we need to have ISO 13485 certification to market our devices; and which countries require this?" One interesting aspect is the actual title of ISO 13485 states "requirements for regulatory purposes," indicating that regulatory agencies would use this standard for this purpose. And they do currently. Many countries outside of the United States and Europe don't have the resources to conduct inspections outside their own borders. Thus, they must rely upon a regulatory standard to assure organizations apply a QMS for compliance. (Refer to the table below for a comparison of regulatory standards by region.). The QMS of a medical device company is then certified by a registrar who audits the organization on a routine basis at least annually. This assures that medical device companies are complying with a known regulatory standard though there are some differences with regions around the world that will be discussed in this article.
 
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Reiko Shiratori

#8
Re: ISO 13485 vs. Japan's Pharmacutical Affairs Law

Hi Bridget,

I'm Japanese and works for a Japanese medical device manufacturer. I guess your customer wants a COA, like Rachel mentioned above.

Frankly speaking, Japanese people are not good at foreign languages (including me :(). Please wait their reply.

Reiko

P.S. I attached Ministerial Ordinance for Medical Device QMS, English version. But it is based on ISO 13485. It might be boring to read almost same requirements.
 

Attachments

Last edited by a moderator:
T

tommychin

#9
Re: ISO 13485 vs. Japan's Pharmacutical Affairs Law

Hi Bridget,

I'm Japanese and works for a Japanese medical device manufacturer. I guess your customer wants a COA, like Rachel mentioned above.

Frankly speaking, Japanese people are not good at foreign languages (including me :(). Please wait their reply.

Reiko

P.S. I attached Ministerial Ordinance for Medical Device QMS, English version. But it is based on ISO 13485. It might be boring to read almost same requirements.

Dear Reiko,
This is Tommy from China. I am working in a pharmaceutical company in international registration department. Currently, we are studying on the Japanese pharmaceutical affairs law. I can read the Japanese version in PMDA's website, but some of my colleagues dont speak Japanese. Do you have an English version of PAL or any link that we can download from?
Looking forward to your relpy.
Thanks a lot.
Tommy
 
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