Responsible Department Name at PMDA

The contact department within the Pharmaceuticals and Medical Devices Agency (PMDA) was the Medical Device Quality Management and Safety Measures Department.

The contact department name has been changed to the Medical Devices Compliance Review Department (医療機器調査部).

Mailing address

The mailing address was the Medical Device Quality Management Section, Medical Device Quality Management and Safety Measures Department. [医療機器品質管理・安全対策部 (医療機器品質管理課)].

The mailing address is the Medical Device Quality Management Section, Medical Devices Compliance Review Department (医療機器調査部).

If there are materials that cannot be disclosed to the applicant and the test facility wishes to submit them directly to PMDA, please consult the investigator after the online submission and clearly explain the reasons for doing so.

The details below have been added.

1. If the manufacturer would like to send materials directly, please send them to PMDA-QMS_Office_1@pmda.go.jp

When sending materials, please note the following:

• Clearly state the QMS conformity inspection system number and the marketing authorization holder (MAH) name in the email subject.
• In the cover letter submitted by the MAH, clearly indicate that there are materials being sent directly from the manufacturer.
• The total size of attached files should be under 8 MB.
• If sending materials in multiple emails, clearly indicate the number of emails (e.g., "1/m", "2/m").
• If compressing files, indicate the relationship between the email containing the password and the email containing the compressed file.

2. If email submission is difficult, paper documents can be mailed. When sending documents by post, please note the following:

• Clearly state the QMS conformity inspection system receipt number and the MAH name.
• In the list of submitted documents provided by the MAH, clearly indicate that there are materials being sent directly from the manufacturer.

Not specified.

When submitting documents directly from the manufacturing site, the use of external cloud storage or similar services for submission can not be used.

Not specified.

On the cover letter for the QMS conformity assessment application, please indicate in the remarks section the name of the facility utilizing MDSAP and its license/registration number.