Regulatory Puzzle 1

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A crossword on regulatory terms and concepts.

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Jean Petersen

United States

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Crossword Puzzle Regulatory Puzzle 1Online version A crossword on regulatory terms and concepts. by 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

Crossword Puzzle

Regulatory Puzzle 1Online version

A crossword on regulatory terms and concepts.

by 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.

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Regulatory Puzzle 1

Crossword Puzzle

About this activity

Created by

Download the paper version to play

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Regulatory Puzzle 1Online version

by 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.