Quality System Documentation (QSD) For Japanese Medical Device Manufacturing Site

Abbreviated Application Mode for the Quality System Documentation (QSD) Conformity Assessment – Japanese Medical Device Manufacturing Site

Based on the “Memorandum of Cooperation on Medical Device Quality Management System” signed by Taiwan and Japan, medical device manufacturers located in Japan may apply for a QSD conformity assessment under an abbreviated application mode.

These manufacturers can submit a QMS Compliance Certificate (產品基準適合証) and a QMS Inspection Report (QMS調查結果報告書) issued by the Pharmaceuticals and Medical Devices Agency (PMDA) or by one of the designated Japanese Recognized Certification Bodies (RCBs) in place of the required QMS procedure documents.

Alternatively, an ISO 13485 Certificate may be used in place of the QMS Compliance Certificate, and an MDSAP Audit Report may be submitted as a substitute for the QMS Inspection Report.

The submission must include a certificate and an audit report

Certificate(s)

QMS Compliance Certificate
(產品基準適合証)

ISO13485 Certificate

Audit report(s)

QMS Inspection/Audit Report
(QMS調査結果報告書)

MDSAP Audit Report

Common Requirements:

Certificates shall cover all applied items.
Both certificates and audit reports should be issued by the same organization.
The approval number (認証番号) of at least one submitted QMS Compliance Certificate shall correspond to the relevant audit report.

The Four Japanese RCBs:

No.	Japanese RCBs	Registration No. in Japan
01	TÜV Rheinland Japan	AB
02	BSI Group Japan	AD
03	SGS Japan	AF
04	TUV SUD Japan	AA

General Notes for the QMS Compliance Certificate and QMS Inspection Report

QMS Compliance Certificate(s) or ISO 13485 Certificate must cover all items included in the QSD conformity assessment application..
The approval number (認証番号) on any one of the QMS Compliance Certificate submitted must link to the relevant QMS Inspection report submitted.

Notes for the QMS Inspection Report to be submitted

Notes for the QMS Inspection Report

The report format can be referred to the QMS調查要領について
The report must be issued within the past three years.
Since the report is written in Japanese, a translation in English or Traditional Chinese is required for TFDA review.
It must not be a summary report (QMS調查結果総括報告書).
In the Section 2 of the report, the name and address of the auditee’s facility (調查对象施設) must be in line with the information going to be registered with QSD Manufacturing License.  In the Section 3 of the report, the Purpose of the Inspection must be specified as “QMS Inspection” (i.e., “QMS調查”).  In the Section 3.3 of the report, the Scope of the Inspection must list in the Chapters 2 and 3 of QMS省令.  In the Section 3.7 of the report, the objective inspection activities for QMS subsystems (e.g., management, document control, design and development, … ) must be specified.  In the Section 4 of the report, the compliance and findings must be confirmed as completed (i.e., 適合していた). If there is any finding (指摘事項), relevant CAPA must be submitted. Finding and correction must be described in Sections 4.1 and 4.2 individually, and the submitted and confirmation date must be recorded as well.
MDSAP Audit report must be used to replace QMS 調査結果報告書. However, the Auditing Organization of the MDSAP Audit Report must be the affiliate of the RCB of the QMS調査結果報告書, i.e., TÜV Rheinland of North America, Inc., BSI Group America, Inc., SGS United Kingdom, Ltd., and TÜV SÜD America, Inc. (also operating as TUV America, Inc.).

Requirements for MDSAP Report:

Format: MDSAP AU F0019.1

Audit type: Initial, Surveillance1, Surveillance2, or Recertification

Validity: Issued within 1 year

Corrective Action: If there is any finding, relevant CAPA shall be submitted.

Additional Requirement: The audit report must include one of the new additional items.