ANSWERED ON THIS PAGE:
- What are the QMS requirements in Japan?
- How do QMS requirements differ for domestic vs. foreign manufacturers?
- How do we comply with the PMD Act and Ordinance 169?
Japan's Pharmaceutical and Medical Device Act (PMD Act)
Japan's PMD Act ("Act on Securing Quality Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics") was issued by the Ministry of Health, Labour, and Welfare (MHLW) in 2014. Among other things, it defines quality management system (QMS) requirements for medical device manufacturers selling their devices in Japan. It also introduced specific requirements for domestic and foreign manufacturers and harmonized QMS requirements with ISO 13485:2003.
Relationship between Ordinance #169 and ISO 13485
Japan has largely embraced ISO 13485 as the basis for their QMS requirements. The PMD Act introduced a more harmonized approach to quality regulations for medical device manufacturers. However, Ministerial Ordinance #169 contains additional QMS requirements you must meet to be in full compliance. Manufacturers with ISO 13485 certification will find compliance with Ordinance #169 is fairly straightforward by adjusting some gaps between ISO 13485 and Ordinance #169.
Foreign manufacturer and MAH QMS audits
According to the PMD Act, manufacturing facilities are subject to a QMS conformity assessment as part of the Japanese registration process. QMS conformity assessments are conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) or a Registered Certification Body (RCB). Foreign manufacturers that have chosen the Foreign Special Approval System route and hold pre-market approvals (Shonin) or certifications (Ninsho) will undergo QMS conformity assessments. Foreign manufacturers must appoint a Designated Marketing Authorization Holder (D-MAH) to represent them in Japan.
QMS conformity assessment certification
Upon successful completion of a QMS conformity assessment, a MAH or manufacturer is issued a Certificate of QMS Conformance (Kijun Tekigoshou) by either the PMDA or RCB. Certificates of conformance are valid for five years and include the registered product name, product group (Seihingun), and manufacturing facility. Under the PMD Act, future conformity assessments focus on devices from the same product group registered with the PMDA or RCB, rather than the manufacturing facility.
We can assist with Ordinance 169 compliance in Japan
Emergo understands how the QMS requirements in Japan, Europe, Korea, Canada, and the US overlap and differ from one another. Armed with this insight, we can assist you in meeting Japan's quality system requirements so you can begin the process of obtaining certification from a RCB or the PMDA. We will:
- Review your quality manual and prepare a gap analysis with references to the appropriate clauses of Ordinance #169.
- Create and propose changes needed to meet the Japan QMS regulation, including preparation of the Device Master File.
- Prepare supplemental documents as an appendix of the quality manual.
- Conduct a mock audit of your quality system prior to your PMDA conformity assessment.
- Prepare the QMS Conformity Assessment application on your behalf.
Please contact us for more information about QMS consulting for Japan and markets worldwide.
Emergo by UL can provide eQMS support in strategic alliance with Greenlight Guru. This helps you leverage an eQMS system designed specifically for the medical device industry. Ask us to schedule a dmo so you can explore a software solution that connects with your processes, people, and data.
Common Questions about Ordinance 169 Compliance
Is our existing ISO 13485 certification accepted as proof of compliance?
An ISO 13485 certificate does not prove compliance with Japan's QMS requirements. Japan Ordinance 169 imposes additional requirements for record retention times, MAH-related requirements, etc. Emergo can assess your current system and address any gaps before completing a conformity assessment audit, if one is required.
We are located outside Japan. Will the PMDA or RCB conduct a desktop or on-site audit?
PMC applications almost certainly require an onsite audit from the RCB, whereas PMA applications are typically subject to a PMDA audit that may be on-site or desktop, depending on your device type. PMC applications require annual surveillance audits that may be desktop, while PMA applications are subject to audits in five year intervals.
What is a Japanese Medical Device Master File?
The Device Master File is one of the key differences between ISO 13485 and Ordinance #169. This document defines the product specifications and QMS requirements (Seihin Hyojun Sho), as well as information about storage, labeling, packaging, testing, and MAH requirements. It is separate from the application file (Todokede, Ninsho, or Shonin) and similar to a European Technical File. The PMDA is very particular about the content of the Device Master File. Supporting documents and details must be consistent with the information submitted for the Todokede, Ninsho, or Shonin - even the smallest differences can cause delays.
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