Medical Device Vigilance Reporting Multi Markets

B

BILLH007

#1
Hello and thanks for your participation.

Queston is on vigilance reporting for medical device
have a 1st draft deision document whichjI will try to incorporate

I am looking for a decision tree or SOP that presents the same process of when and where to file incident (serious event reporting,

Reporting situation draft is pasted below.

This is not my strong suit. Any feedback is appreciated.

MDR and Incident Reporting Decision Situations

Based on Location of Occurrence:

SituationUSA01:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved not sold anywhere else
Report to FDA using Form 3500A

SituationUSA02:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved sold in EU
Report to FDA using Form 3500A

SituationUSA03:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved sold in Canada
Report to FDA using Form 3500A
Report as required to Health Canada

SituationUSA04:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved sold in Japan
Report to FDA using Form 3500A
Report to JAL

SituationUSA05:
Adverse event occurs only in USA
Same or similar Device with feature/mechanism involved sold in Canada
Same or similar Device with feature/mechanism involved sold in Japan
Report to FDA using Form 3500A
Report as required to Health Canada
Report to JAL

SituationUSA&EU 01:
Adverse events occurs in USA and EU
Same or similar Device with feature/mechanism involved sold in both Markets
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A


SituationUSA&EU 02:
Adverse events occurs in USA and EU
Same or similar Device with feature/mechanism involved sold in both Markets
Same or similar Device with feature/mechanism involved sold in Canada
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
Report as required to Health Canada


SituationUSA&EU 03:
Adverse events occurs in USA and EU
Same or similar Device with feature/mechanism involved sold in both Markets
Same or similar Device with feature/mechanism involved sold in Japan
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
Report to JAL

SituationUSA&EU 04:
Adverse events occurs in USA and EU
Same or similar Device with feature/mechanism involved sold in both Markets
Same or similar Device with feature/mechanism involved sold in Canada
Same or similar Device with feature/mechanism involved sold in Japan
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A
Report to JAL

SituationEU01:
Adverse event occurs only in EU
Same or similar Device with feature/mechanism involved sold in USA
Report through Authorized representative
Report to FDA using Form 3500A

SituationEU02:
Adverse event occurs only in EU
Same or similar Device with feature/mechanism involved sold in USA
Same or similar Device with feature/mechanism involved sold in other EU countries
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A

SituationEU03:
Adverse event occurs only in EU
Same or similar Device with feature/mechanism involved sold in USA
Same or similar Device with feature/mechanism involved sold in other EU countries
Same or similar Device with feature/mechanism involved sold in Canada
Report through Authorized representative and determine all EU markets
Report to FDA using Form 3500A

Report as required to Health Canada

SituationEU04:
Adverse event occurs only in EU
Same or similar Device with feature/mechanism involved sold in other EU countries
Report through Authorized representative and determine all EU markets

SituationEU05:
Adverse event occurs only in single EU market/State
Report through Authorized representative

SituationCA01:
Adverse event occurs only in Canada
Same or similar Device with feature/mechanism involved sold in USA
Report as required to Health Canada
Report to FDA using Form 3500A

SituationCA02:
Adverse event occurs only in Canada
Same or similar Device with feature/mechanism involved sold in USA
Same or similar Device with feature/mechanism involved sold in EU
Report as required to Health Canada
Report as required to FDA using Form 3500A
Report through Authorized representative and determine all EU markets

SituationCA03:
Adverse event occurs only in Canada
Same or similar Device with feature/mechanism involved sold in USA
Same or similar Device with feature/mechanism involved sold in EU
Same or similar Device with feature/mechanism involved sold in Japan
Report as required to Health Canada
Report as required to FDA using Form 3500A
Report through Authorized representative and determine all EU markets
Report to JAL
 
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