extension [1..1] Alpha Numeric This attribute provides a location to specify a regional specific application tracking number. Business Rules XPATH Root extension applicationReference.reasonCode Element Attribute Cardinality Value(s) Allowed Examples Description Instructions reasonCode [1..*] This is a container element that organizes the coded value for the reason an application is being referenced. code [1..1] Alpha Numeric . The code is a unique that indicates the reason for referencing an application based on Regional Controlled Vocabulary codeSystem [1..1] Valid OID The codeSystem is a unique identifier that indicates the controlled vocabulary system. This should be the OID registered for the code system. Business Rules Provide as many application references as necessary for the application being submitted. XPATH code
code codeSystem Submission A submission is considered the Regulatory Activity, which often results in a decision or action against the complete set of regulatory content submitted for consideration. Each application type will have valid submission types. This will be specified by each regulatory authority. (Should we provide examples for some authorities here) For testing purposes, the submission identifier should be globally unique and assigned by the submitter. The following XML snippet shows the submission element: <componentOf> <submission> <id xsi:type="DSET_II"> <item root=""/> </id> <code code="" codeSystem=""/> … [add description of additional information here] … </submission> </componentOf> submission.id Element Attribute Cardinality Allowed Examples Description Instructions id.item [1..1] This is a container element of the following attributes by which it uniquely identifies the submission. root [1..1] Valid UUID This attribute is for a global unique identifier. extension [1..1] Alpha Numeric This attribute provides a location to specify a regional-specific submission
<id root=""/> <code code="" codeSystem=""/> <title value=""/> <statusCode code=""/> </submissionUnit> </subject> submissionUnit.id Element Attribute Cardinality Value(s) Allowed Examples Description Instructions id [1..1] This is a container element of the following attributes by which it uniquely identifies the Submission Unit. root [1..1] Valid UUID This attribute is for a global unique identifier. Business Rules XPATH id /PORP_IN000001UV/controlActProcess/subject/submissionUnit/id/@root submissionUnit.code Element Attribute Cardinality Value(s) Allowed Examples Description Instructions code [1..1] This is a container element that organizes the coded value for the submission unit. code [1..1] Alpha Numeric e.g., pending example The code is a unique value that indicates the submission unit value based on regional Controlled Vocabulary codeSystem [1..1] Valid OID The codeSystem is a unique identifier that indicates the controlled vocabulary system.
This should be the OID registered for the code system. Business XPATH code /PORP_IN000001UV/controlActProcess/subject/submissionUnit/code/@code codeSystem submissionUnit.title Element Attribute Cardinality Value(s) Allowed Examples Description Instructions [0..1] This is a container element that organizes the title of the submission unit. value [1..1] String e.g., This attribute is for a string value that describes the submission unit. Business Rules XPATH value /PORP_IN000001UV/controlActProcess/subject/submissionUnit/title/@value submissionUnit.statusCode Element Attribute Cardinality Value(s) Allowed Examples Description Instructions statusCode [0..1] This is a container element that organizes the coded value for the status code. code [1..1] Alpha Numeric e.g., active The code is a unique value that indicates the status code based on HL7 vocabulary. Business XPATH Code
The classCode and moodCode are not required in the RPS XML message, the classCode is fixed to “ACT” and moodCode is fixed to “EVN”. contextOfUse.id Element Attribute Cardinality Value(s) Allowed Examples Description Instructions id [1..1] This is a container element that organizes the context of use. root [1..1] Valid UUID This attribute is for a global unique identifier. Business Rules The id@root should be unique for every contextOfUse submitted. The Context of Use id@root should only be reused to reactivate a previously inactive Context of Use. XPATH root contextOfUse.code Element Attribute Cardinality Value(s) Allowed Examples Description Instructions [1..1] This is a container element that organizes the coded value for the context of use. code [1..1] Alpha Numeric e.g., pending example The code is a unique value that indicates the Context of Use code based on IMDRF and Regional Controlled Vocabulary. codeSystem [1..1] Valid OID The code system is a unique identifier that indicates the controlled vocabulary system.
[1..1] This is the container for the title element of a document. value [1..1] Alpha Numeric title e.g., “General Information” This is the attribute for the document. This is a value for each document. updateMode [0..1 ] Alpha E.g., A = Add, R= Replace This is the updateMode attribute that is used if updating the document.title element. Business The element should be used to indicate a human-readable value when displaying the document file to others. When sending a change in the title element, the title@updateMode attribute should be provided. XPATH value updateMode document.text Element Attribute Cardinality Value(s) Allowed Examples Description Instructions text [0..1] This is a container element that provides additional information about the document. [1..1] SHA256 This is the type of integrityCheckAlgorithm that was used for the checksum values provided in integrityCheck element. language [0..1] Alpha Refer to ISO 639.1 for two-letter This is the language attribute to indicate the language for the document.
</documentReference> </derivedFrom> The classCode and moodCode are not required in the RPS XML message, the classCode is fixed to “ACT” and moodCode is fixed to “EVN”. Conditions that apply to the documentReference element: Zero to one documentReference elements can be sent for each contextOfUse. For a contextOfUse.statusCode= active – the documentReference element is required. For a contextOfUse.statusCode= inactive – the documentReference element should not be provided. documentReference.id Element Attribute Cardinality Allowed Examples Description Instructions id [1..1] This is a container element for a reference to a Document. root [1..1] Valid UUID This attribute is for a global unique identifier of the Document being referenced. Business Rules The id@root is a reference to a document sent in the submission unit or a previously submitted submission unit. root Keywords Keywords are code values that indicate a keyword that is used in conjunction with the Context of Use value (i.e., table of content heading) to organize submission contents. The following XML provides an example of how to provide the keyword as a reference on either a Context of Use or Document. The following XML snippet the keyword element: <referencedBy> <keyword> <code code=“IMDRF-Species-4” codeSystem=“2.16.840.1.113883.3.989.2”/> </keyword> </referencedBy>
<referencedBy> <keywordDefinition> <code code=“IMDRF-manufacturer” codeSystem=“2.16.840.1.113883.3.989.2”/> <statusCode code=“active”/> <value> <item code=“MANU001” <displayName value=“Big Device Manufacturer”/> </item> </value> </keywordDefinition> </referencedBy> The classCode and moodCode are not required in the RPS XML message, the classCode is fixed to “ACT” and moodCode is fixed to “EVN”. Conditions that apply to the keywordDefinition element: Zero to many keywordDefinition elements can be sent for each application element A keywordDefinition should be provided for sender-specified keywords. keywordDefinition.code Element Attribute Cardinality Value(s) Allowed Examples Description Instructions code [1..1] This is a container element that identifies the type of keyword definition. code [1..1] Alpha Numeric e.g., This is the code attribute for the coded value of the type of keyword definition. codeSystem [1..1] Valid OID This is the codeSystem OID that is a unique identifier for the controlled vocabulary system. This should be the OID registered for the code system. Business The code must be from a Keyword code type. XPATH
code codeSystem keywordDefinition.statusCode Element Attribute Cardinality Allowed Examples Description Instructions statusCode [1..1] This is a container element that identifies the status of the keywordDefinition. code [1..1] Alpha e.g., active This is the code value for the status. Business Rules The code attribute should always have a of “active”. XPATH code Element Attribute Cardinality Value(s) Allowed Examples Description Instructions value [1..1] This is a container element for the keyword defined for the keyword code provided for keywordDefinition. value.item [1..1] This is a container element to specify an individual keyword identifier. code [1..1] Alpha Numeric Sender specified value e.g., MANU001 This is the code attribute for the keyword being defined.
CH1.5 Quality Management System, Full Quality System or Product Certification Certificate 1 PDF document Filename: Cert # z5646 Document Sterilizer Delta QS Certificate Lifecycle Reference existing document for G3 only to show it is still current. NOTE: this would be a new COU in the G3 regulatory activity with a reference back to the document previously submitted. COU Keywords: Certificate Type: Quality System Document Keywords Certificate Body ID: 0776 Certificate Number: z5646 CH1.17 Declaration of Conformity 1 PDF File Filename: DoC.pdf Document Title: Declaration of Conformity Lifecycle: Version G2 COU Keywords Product: THR NO Document Keywords CH1.17 Declaration of Conformity 1 PDF File Filename: DoC2.pdf Document Title: Declaration of Conformity Lifecycle Version G3 COU Keywords Product: Device 22 NO Document Keywords