Quality Monitoring of Imported Medical Devices
The government is set to enhance the quality control of imported medical devices by adopting a risk-based approach. This new initiative will involve random sampling for quality testing, while critical diagnostic kits will undergo comprehensive testing of the entire shipment. A guidance document has been issued to assist port officers in making informed decisions, ensuring public health safety remains the top priority.
The document outlines a strategy for monitoring the quality of imported medical devices, cosmetics, and drugs at ports. It emphasizes a systematic, risk-based procedure in which random samples will be collected for quality checks, and critical items, such as diagnostic kits, will be tested in their entirety. “Ensuring the quality of imported products is crucial to protecting public health,” the guidance states.
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The document further details the implementation of a three-tier risk-based sampling approach. Inspections will begin with desktop or visual assessments, followed by field-based testing using tools like Minilab screening devices, and if necessary, full laboratory testing for comprehensive analysis.
“The results of these tests will be considered final for any necessary action,” it adds. In cases where port or customs officers receive reports or evidence of questionable product quality, samples must be collected and sent for testing. This applies to 100% of certain high-risk items, including vaccines, blood products, critical diagnostic kits, condoms, and re-imported goods.
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