REG Regulatory Application
REG Regulatory Application
To describe what regulatory requirements are associated with the product.
Position
Element
Name
Type
Requirement
Min
Max
Repeat
REG-01
Regulatory Type
Identifier (ID)
Mandatory
2
2
-
Type of legislation.
REG01 identifies the regulatory type, REG02 and REG03 identify where the regulation pertains, and REG04 confirms the applicability.
REG-02
Country Code
Identifier (ID)
Conditional
2
3
-
Code identifying the country
REG02 is recommended, if there is a possibility of confusion when declaring the State or Province code.
REG-03
Conditional
-
REG-04
Yes/No Condition or Response Code
Identifier (ID)
Optional
1
1
-
Code indicating a Yes or No condition or response
REG04 declares the relationship of REG01 with REG02 and REG03.