Doing a Medical Device Master File in Japan

Background information

The original Japanese Device MF system was established in December 2000. This system is called the “Old MF system”. At that time, the applicable raw materials were limited to Polyvinylchloride, Polyethylene, and Polypropylene.

The current Device MF system was established in May 2019. This system is called the “New MF system”. Any raw materials can be registered as long as the PMDA decides that the registration of such material is appropriate.

How to file a Device MF

 For registration of medical device raw materials, the first thing to do is attend a consultation session with the PMDA. This consultation category is called “Zenpan soudan” (general consultation). At this consultation session, manufacturers of medical device raw materials can present information about the raw material that they want to register. After the consultation, the PMDA will determine whether or not the registration of this raw material is appropriate. It will take about a month from the request for consultation until the PMDA makes their decision.

After the PMDA decides that the registration of the raw material is appropriate, the foreign manufacturer can start preparing a submission dossier and apply for registration.

How long does it take to get approved?

After the application is accepted by the PMDA, it will take about 15 days or so for the MF registration to be issued to the manufacturer of the raw material, who will then become the MF holder. Please note that the PMDA only evaluates the completeness of the submission dossier and does not thoroughly investigate the contents of the dossier until the MF of the raw material is referenced in a registration application for a final medical device product.

 The PMDA will thoroughly review the contents of the master file documents when the approval application of the final medical device product is submitted. If the PMDA raises any issues in regard to the contents of the MF registration, the MF holder will be required to correct or supplement the MF registration.

 Information (documents) to be submitted for MF registration (ex: synthetic polymer)

     A. Generic name

     B. General chemical information

  1. Chemical name
  2. CAS number, USAN name, Chemical Substances Control Law notification number
  3. Structural formula
  4. Molecular weight, etc. (Melted index, viscosity may be used if difficult)
  5. Low molecular weight component
  6. Amount of water-soluble component

     C. Information from raw material manufacturers

  1. Manufacturer name
  2. Product name (generic name and product name)
  3. Product number or symbol
  4. Material specifications, product specifications (including test methods)
  5. Types and amounts of additive ingredients

     D.Official standard names and numbers (JIS, ISO, ASTM, JP, USP, EP, etc.)

     E. Master file registration number

     F. Chemical analysis

  1. Identification and quantification of solvent extracts, etc.
  2. Material chemistry test
  3. Analysis of polymer structure (ATR, FT-IR or GC, etc.)

 

Contact us today to learn more about how Pacific Bridge Medical can help you file a device MF in Japan.