Request for Information; Application for Accreditation

#1
Dear all,

I hope this post finds you doing well. I work for a manufacturer in the USA. We are interested in exporting a laser light source for medical applications to an OEM in Japan. The OEM is requesting we register with the PMDA. There are some translation issues. I am assuming they are referring to an Application for Accreditation. I am using the following link for information

pmda.go.jp/files/000153619.pdf

The document in that link says we must submit “Application for Accreditation” (Form No. 18 in the PAL Enforcement Regulations) and an “Application for Accreditation Examination” (Form No.16-(2) in the Regulations) .

After hours of searching, I am not able to find form No. 18 or form No.16-(2).


Is anyone familiar with this process and willing to walk me through the steps? It would also be helpful to get an understanding of where this application should be sent, who is should be addressed to, and expected feedback and timelines.

Any information or insight would be greatly appreciated,

Thank you and kind regards,

Bender
 

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