On June 1, 2022, Japan’s PMDA‘s Medical Device Quality Control and Safety Measures Department issued an administrative communication called the “Documents to be submitted when applying for a QMS conformity inspection.” Administrative documents with the same QMS content have been published for some time, but this latest version makes the template of the material to be submitted even easier to understand. For example, critical suppliers without FMRs (Foreign Manufacturer Registrations) have been included to show the relationships of the relevant facilities of the manufacturer. Also, in another example, the DMR (Device Master Record) summary has more examples of the description of document names than before. Reading this new document is recommended when applying for a QMS inspection when the relevant medical device or drug IVD is applying for a Shonin approval from the PMDA.
For medical devices and in-vitro diagnostic drugs that will be certified by a registered certification body, each certification body often prepares its own QMS templates, so it is recommended to consult with the certification body you are planning to use. But if the certification body does not have its own templates, PMDA QMS templates are very useful and can be used. The previous QMS guidelines have also been improved. The PMDA now accepts electronic applications for QMS conformity inspections via the “Gateway.” The Gateway is the electronic application system of the PMDA originally developed for drug approval applications. The new document also provides details on how to assign file names to each document and other precautions that may apply. As a general rule, one electronic file should be created for each document number. Some examples are below.
- A copy of the marketing approval application (document number 1-1-1)
- A copy of the ISO13485 certificate or other certificate issued by a foreign government authority (document number 1-1-3)
- Summary of the manufacturing process (document number 1-1-4)
- Summary of relevant facilities (document number 1-2-1)
- Organization chart of relevant facilities (document number 2-2-1)
- Quality manual (document number 2-2-2)
The file names should be such named – “Document number x-x-x.” Each of the files (“x-x-x”) is pre-determined by the PMDA’s rule described in this guidance.
The latest version of the guidance on the materials to be submitted in the QMS conformity inspection has been published by the PMDA. There are no English versions available yet, but the Japanese versions can be accessed via the link below.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.pmda.go.jp/english/review-services/gmp-qms-gctp/0002.html