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- Government introduced a risk-based model for testing imported medical devices.
- The government has decided to implement a risk-based strategy to monitor the quality of imported medical devices and Kits.
- Under this monitoring, the samples will be selected randomly for quality testing.
- In the case of essential diagnostic kits, the entire shipment will be tested.
- A comprehensive document has been issued to assist port officers regarding the quality control of imported medical devices.
- The proposed guidelines introduce a structured three-tier sampling system to improve quality assurance.
- It includes desktop or visual inspections, field-based tests using Minilab or similar tools, and full laboratory tests.
- Vaccines, blood products, condoms, and critical diagnostic kits all samples will be sent for testing.
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