MAH/DMAH have responsibility to report adverse events to PMDA

Foreign manufacturer is not required to report any adverse events directly

Reporting timeframes are set

MAH or manufacturer needs to have good relations/communications with the actual customers

Must try to recover any explanted products for investigation, review, and analysis

Maintain a complaint trending system

Close the investigation reports in a timely manner

Maintain an English version of the events or recalls

Conduct regular literature searches; quarterly or preferably monthly document review

Report on instances discovered during clinical trials

15 days:

Death have occurred and suspected to be due to a fault in the registered medical device and/or overseas medical device

The following cases are suspected to be due to a fault in the registered medical device and/or identical overseas medical device and that ARE NOT IDENTIFIED/PREDECTABLE among the labeled precautions of this medical device

A) Disability

B) Cases that may lead to death or disability

C) Cases for which hospitalization (or prolongation of the hospitalization period) to a hospital or clinic is necessary for treatment (excluding cases that may lead to death or disability)

D) Death or serious cases listed above

E) Congenital diseases or inheritable abnormalities

Excess Adverse Events
Adverse events have occurred and exceeded the incidence rate predicted in advance (only for medical devices specified by MHLW)

30 days:

Occurrence of deaths or the following cases that are suspected as being due to the faults of the registered medical device or overseas medical devices

The following cases are suspected to be due to a fault in the registered medical device and/or identical overseas medical device and that ARE NOT IDENTIFIED/PREDECTABLE among the labeled precautions of this medical device

A) Disability

B) Cases that may lead to death or disability

C) Cases for which hospitalization (or prolongation of the hospitalization period) to a hospital or clinic is necessary for treatment (excluding cases that may lead to death or disability)

D) Death or serious cases listed above

E) Congenital diseases or inheritable abnormalities

Annual Report

Need to report every year within 2months from the date of approval for the following adverse events;

Excess Adverse Events suspected to cause the following cases

Adverse events other than deaths or the following cases that are suspected as being due to the faults of the registered medical device or overseas medical devices that ARE NOT IDENTIFIED/PREDECTABLE among the labeled precautions of this medical device

Adverse events other than the following cases that ARE NOT IDENTIFIED/PREDECTABLE among the labeled precautions of this medical device

A) Disability

B) Cases that may lead to death or disability

C) Cases for which hospitalization (or prolongation of the hospitalization period) to a hospital or clinic is necessary for treatment (excluding cases that may lead to death or disability)

D) Death or serious cases listed above

E) Congenital diseases or inheritable abnormalities

MAH/DMAH have responsibility to recall report (for start and completion) to the prefecture that MAH/DMAH locate

Foreign manufacturer is not required to report directly

MAH/DMAH or manufacturer needs to have good relations/communications with the distributors and the actual customers

Recall Classification

• Class I

  Class II

  Class III

• ・・・

  ・・・

  ・・・

• Use of medical devices subject to recall cause to severe health hazards or death

  Other than Class I and III (most of recalls are Class II)

  Unpredictable use of medical devices subject to recall cause to severe health hazards