12.

12.1.

12.1.1.

12.1.2.

12.2.

12.2.1.

12.2.2.

12.2.3.

12.2.4.

12.2.5.

12.3.

12.3.1.

12.3.2.

12.4.

12.4.1.

12.4.2.

12.4.3.

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11. Regulatory Submission Pathways

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13. Post-Market Surveillance and Activities