Receiving regulatory intelligence reports is a crucial part of addressing all complex issues related to bringing medical products to the market. These issues encompass various aspects, from compliance document screening and error analysis to meet labeling requirements and (pre)clinical testing, market access licenses. They include:
1. Classification according to the regulations of medical devices or IVDs. Potential issues/complaints may affect classification according to regulations.
2. Refer to all currently applicable laws.
3. Body/bodies are in charge of legislation(s) in the market: Identify the agency/organization responsible for each regulated area in the market
4. Registration process, change notification, supplementation, and license transfer, timescales
5. Registration, change notification, license transfer costs (fees).
6. Labeling requirements.
7. Product registration-related testing requirements:
8. Market access requirements: including local authorization, import/export restrictions, customs, and taxes.
9. Monitoring market authorizations that may exist in the target market:
for example, in the context of a pandemic like COVID-19, with specific timelines and standards for every status and temporary control.
10. Post-market surveillance requirements.
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