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Revision of the Pharmaceutical Affairs Law
Major Elements
I. Marketing Authorization Holder (MAH) or designated Marketing Authorization Holder (dMAH)
It had to imagine, however, all application file must be submitted through MAH or dMAH for overseas manufacturer. MAH must have address here in Japan like FDA agent for overseas manufacturers. MAH has ultimate responsibility to supervise overseas manufacturers. Contact us for further information about MAH or dMAH
II. Requirements Prior to Device Marketing
1. Review of quality, efficacy and safety of the device �E�Eroduct Approval Application)
2. QMS Compliance surveillance (Product by Product)
3. MAH License
4. License for Manufacturer or Accreditation of foreign manufacturer
III. Documents to be submitted for QMS Surveillance
1. Copies of Report on QMS Surveillance by Government/Notified Bodies for the past 2 years
2. Certificate of ISO 13485 or other certificate for QMS if applicable
3. Copy of Device approval/certification application file
4. QMS related Documents
IV. Accreditation of Foreign Manufacturer and QMS
All overseas Manufacturers must obtain accreditation and product QMS check
until renewal of import license of the importer in Japan.
V. Three Controllers for MAH
2-General responsible director, Responsible director for quality management, and Responsible director for safety use are three controllers for MAH.
These directors are necessary under the revised PAL. It is also necessary to prepare procedures in which roles of these directors are described. Procedures for quality control is called GQP, which includes receiving of inspection and release of devices.
In addition, procedure called GVP shall cover collection of safety related information in the use of the devices and implementation of necessary measures for securing safety use of the devices.
MIC Medical Corp. gives support for preparation of procedures and contracts, process Software Validation, Risk Management and Audit for foreign manufacturers. All of them are required under the revision of the PAL.
（Inquiry / Request for Brochure）
MIC Medical Corp.
Yushima Urban Bldg, 2-31-22 Yushima, Bunkyo-ku,Tokyo 113-0034 Japan
Business development Dept.
Hidenori Numata
Tel: +81-3-3818-8580 Fax：+81-3-3818-8570
Inquiry
（Please make sure to mention your COMPANY NAME, ADDRESS, and TELEPHONE NUMBER in the inquiry form)
Direct Regulatory Affairs Dept.
Kenichi Sakamoto
Tel: +81-3-3818-8201 Fax：+81-3-3818-8570 Inquiry
（Please make sure to mention your COMPANY NAME, ADDRESS, and TELEPHONE NUMBER in the inquiry form)
