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Changes to a Medical Device

  • Changes to a medical device marketed in Japan are subject to one of the following four regulatory actions:

      No regulatory procedure needed

      Minor Change Notification ("Keibihenko Todokede")

      Must be submitted within 30 days of a device change occurring

      Partial Amendment Application ("Ichibu Henkoh Shinsei")

      Must be approved before release of changed devices into the Japanese market

      New registration submission

  • Guidance documents from MHLW and PMDA:

      MHLW Notification Yakushokukihatsu No.1023001 (October 23, 2008)

      "Decision Tree for determining Needed Procedure to Change Pre-market Approval (January 2010)" issued by PMDA

    • Changes to a Medical Device - Cont'd

  • Recall Risk

  • Recall risk from failure to submit a Minor Change Notification or Partial Amendment Application

  • Guidance documents from MHLW and PMDA:

      If a MAH (including quasi-MAH) releases a changed device into the Japanese market without submitting a Minor Change Notification or obtaining approval for a Partial Amendment Application, that MAH must. recall its changed devices from the market.

      Thus, MAHs must ensure that all changes to their devices are reported to Japanese regulators in order to avoid the risk of recall

      Recommend to take PDMA's pre-consultation for determining necessary regulatory procedures if not clear

    • Japan Change Assessment Decision table

    Change assessment question Response action
    YES NO
    (1) Is the change due to a Class I Recall or event reported to the PMDA? Consult with PMDA via MAH/DMAH Continue to (2)
    (2) Is it a labeling change (no change to device)? Continue to (5) Continue to (3)
    (3) Is it a change to the device or related to engineering for shape/structure, etc. Continue to (10) Continue to (4)
    (4) Is it a change in material used? Continue to (22) No regulatory procedure needed
    (5) Is it a change to the registered trade name? Partial Amendment Application Continue to (6)
    (6) Is it a change to the intended use? Partial Amendment Application Continue to (7)
    (7) Is it a change in warning, contraindication or precaution? No regulatory procedure needed OR Minor Change Notification Continue to (8)
    (8) Change to clarify device operation method / usage? No regulatory procedure needed OR Minor Change Notification Continue to (9)
    (9) Does the change impact device safety and efficacy? Partial Amendment Application Continue to (10)
    (10) Is it a change in mechanism of operation? New Application OR Partial Amendment Application Continue to (11)
    (11) Is it a change in energy type? New Application OR Partial Amendment Application Continue to (12)
    (12) Is it a change in performance or specifications? Continue to (19) Continue to (13)
    (13) Is the change related to usability? Continue to (19) Continue to (14)
    (14) Is it a change in size or shape? Continue to (19) Continue to (15)
    (15) Is it any other type of engineering change not covered by (10)-(14)? Continue to (19) Continue to (16)
    (16) Does the change impact the period of product stability? Minor Change Notification OR Partial Amendment Application Continue to (17)
    (17) Is it a change in sterilization method? Partial Amendment Application Continue to (18)
    (18) Is it a change in sterilized packaging? Minor Change Notification No regulatory procedure needed
    (19) Is the change related to intended use? Partial Amendment Application Continue to (20)
    (20) Is Clinical Evaluation necessary to establish safety /efficacy? Partial Amendment Application Continue to (21)
    (21) Does the change impact quality, efficacy and safety? Partial Amendment Application No regulatory procedure needed
    (22) Does the change impact performance/function? Go back to (10) Continue to (23)
    (23) Is it a change in biological material? Partial Amendment Application Continue to (24)
    (24) Is it a change in the type of material? Continue to (28) Continue to (25)
    (25) Does the material come into contact with the body or bodily fluids? Continue to (26) No regulatory procedure needed
    (26) Is the change reflected in a change in the material standard attachment (as part of the original application)? Continue to (27) No regulatory procedure needed
    (27) Are there any predicate devices? Minor Change Notification Partial Amendment Application
    (28) Is the device implantable? Continue to (29) Continue to (30)
    (29) Does the material come into contact with the body or bodily fluids? Partial Amendment Application No regulatory procedure needed
    (30) Does the material come into contact with the body or bodily fluids? Continue to (31) No regulatory procedure needed
    (31) Are there any predicate devices? Continue to (32) Partial Amendment Application
    (32) Does the change impact quality, efficacy and safety? Partial Amendment Application Minor Change Notification