Japan Medical Devices Regulations

[Tiffany]

Dear mates,

Is there any experts who know the process should a medical device manufacturer to go through when they wanted to put their medical devices in the Japan market?

How does the process look like to approach and get approval from Japan MHLW(Ministry of Health Labor and Welfare)?

Secondly, whats the difference of GMP and JGMP???
Is there any guide on this?




Tiffany

 

[jkuil]

Re: Japan Medical Devices Regulation

Please read the following training I have generated

 

[MIREGMGR]

Jkuil, thank you very much for the useful training document.

We have several large multinational customers that have been selling our products worldwide, including Japan, under their names for a number of years, probably without direct regulatory oversight. In many countries, our sterile-equipment-cover products are perceived as accessories for relatively major medical systems that, paradoxically, get little or no regulatory attention because they involve capital expenditures and therefore typically have been purchase-approved by VIPs. Accessories for those systems get a continuing free ride on that regulatory exception.

This of course is formally inappropriate and non-compliant, and puts us as the accessory-device manufacturers in an uncomfortable position.

We have a current opportunity to work with one such customer's regulatory people to improve their and our Japanese-regulatory-compliance approach. I may be able to use this presentation to help in that effort.

 

[Ajit Basrur]

Jkuil,

Thanks for the great info.

 

[Tiffany]

Dear Mates,

Million of thanks...... Is a useful information

I will look into it.



Tiiff

 

[Tiffany]

Dear Mates,

How about JGMP and GMP??? Whats the difference between this two??

Tifffi

 

[Ajit Basrur]

Dear Mates,

How about JGMP and GMP??? Whats the difference between this two??

Tifffi

There are plenty of threads on the subject and you could SEARCH through the forum. My "pick" that explains your subject is from my friend, Gert at Comparison of ISO 13485, FDA and JGMP

 

[Tiffany]

Dear Ajit,


The link is useful but the file is corrupted!

Is there any other to get it?

Thanks for the help!

TiiFF

 

[Ajit Basrur]

Dear Ajit,


The link is useful but the file is corrupted!

Is there any other to get it?

Thanks for the help!

TiiFF

Try this

 

[smward]

Re: Japan Medical Devices Regulation

I am hoping you can assist me.
I am looking for an english document that outlines the 16 articles for the essential requirements for Japan medical devices as discussed in announcement #122 (March 2005).

"Standards for medical devices designated by the MHLW based on the provisions of Article 41, Paragraph 3 of the PAL (Announcement No 122 March 29 Heisei 17 2005. The essential requirements are composed of general requirements Chapter 1 (articles 1-6) and design and manufacturing requirements of chapter 2 (Artciles 7-16).

Any help greatly appreciated

-- Suzanne
Portland OR