Regulatory Puzzle 1

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A crossword on regulatory terms and concepts.

Créé par

Jean Petersen

United States

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Regulatory Puzzle 1


Mots Croisés Regulatory Puzzle 1Version en ligne A crossword on regulatory terms and concepts. par Jean Petersen 1 A _____country is defined as those countries that do not have country specific decision trees in the Regulatory Assessment section of the RCMM. This includes EU-EEA countries with additional local registration requirements beyond that of EUDAMED. 2 A _____survey is sent to determine the impact that a design change will have on ROW county registrations. 3 No response to a GRIA survey will result in the country being placed on __________ for the impacted part number at implementation of the change. 4 If a GRIA survey response indicates that the country registration is impacted by the design change, Commercial RA will open a ______ request and tag the _____ record with the RCMM RCA record ID to track the request. 5 A GRIA impact of __________ only is defined as: A regulatory agency requires submission of a formal notification of this change. 6 A GRIA impact of __________ Required indicates that there are premarket activities required prior to the product being sold in the country. 7 To modify an RCMM record after approval, change the Appendix G Subcommittee Decision to status to _________, edit the record, mark again as approved and re-route for approval. 7 4 2 1 3 1 A _____country is defined as those countries that do not have country specific decision trees in the Regulatory Assessment section of the RCMM. This includes EU-EEA countries with additional local registration requirements beyond that of EUDAMED. 2 A _____survey is sent to determine the impact that a design change will have on ROW county registrations. 3 No response to a GRIA survey will result in the country being placed on __________ for the impacted part number at implementation of the change. 4 If a GRIA survey response indicates that the country registration is impacted by the design change, Commercial RA will open a ______ request and tag the _____ record with the RCMM RCA record ID to track the request. 5 A GRIA impact of __________ only is defined as: A regulatory agency requires submission of a formal notification of this change. 6 A GRIA impact of __________ Required indicates that there are premarket activities required prior to the product being sold in the country. 7 To modify an RCMM record after approval, change the Appendix G Subcommittee Decision to status to _________, edit the record, mark again as approved and re-route for approval. 7 4 2 1 3 1 Adherence to laws, regulations, and internal policies. 2 A written law passed by a legislative body. 3 A government body responsible for enforcing laws and regulations. 4 Supervision and monitoring to ensure rules are followed. 5 Official penalty or permission used to influence behavior. 6 Government order prohibiting trade or movement of goods. 7 Official permission to practice a profession or operate a business. 8 A formal change or addition to a law or document. 8 1 6 4 5 7 3 2

Regulatory Puzzle 1

Mots Croisés

À propos de cette activité

Créé par

Téléchargez la version pour jouer sur papier

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Regulatory Puzzle 1Version en ligne

par Jean Petersen

A _____country is defined as those countries that do not have country specific decision trees in the Regulatory Assessment section of the RCMM. This includes EU-EEA countries with additional local registration requirements beyond that of EUDAMED.

A _____survey is sent to determine the impact that a design change will have on ROW county registrations.

No response to a GRIA survey will result in the country being placed on __________ for the impacted part number at implementation of the change.

If a GRIA survey response indicates that the country registration is impacted by the design change, Commercial RA will open a ______ request and tag the _____ record with the RCMM RCA record ID to track the request.

A GRIA impact of __________ only is defined as: A regulatory agency requires submission of a formal notification of this change.

A GRIA impact of __________ Required indicates that there are premarket activities required prior to the product being sold in the country.

To modify an RCMM record after approval, change the Appendix G Subcommittee Decision to status to _________, edit the record, mark again as approved and re-route for approval.

A _____country is defined as those countries that do not have country specific decision trees in the Regulatory Assessment section of the RCMM. This includes EU-EEA countries with additional local registration requirements beyond that of EUDAMED.

A _____survey is sent to determine the impact that a design change will have on ROW county registrations.

No response to a GRIA survey will result in the country being placed on __________ for the impacted part number at implementation of the change.

If a GRIA survey response indicates that the country registration is impacted by the design change, Commercial RA will open a ______ request and tag the _____ record with the RCMM RCA record ID to track the request.

A GRIA impact of __________ only is defined as: A regulatory agency requires submission of a formal notification of this change.

A GRIA impact of __________ Required indicates that there are premarket activities required prior to the product being sold in the country.

To modify an RCMM record after approval, change the Appendix G Subcommittee Decision to status to _________, edit the record, mark again as approved and re-route for approval.

Adherence to laws, regulations, and internal policies.

A written law passed by a legislative body.

A government body responsible for enforcing laws and regulations.

Supervision and monitoring to ensure rules are followed.

Official penalty or permission used to influence behavior.

Government order prohibiting trade or movement of goods.

Official permission to practice a profession or operate a business.

A formal change or addition to a law or document.

If a GRIA survey response indicates that the country registration is impacted by the design change, Commercial RA will open a __ request and tag the _ record with the RCMM RCA record ID to track the request.

If a GRIA survey response indicates that the country registration is impacted by the design change, Commercial RA will open a __ request and tag the _ record with the RCMM RCA record ID to track the request.