Govt introduces risk-based model for testing imported medical devices, kits

The risk-based approach allows authorities to assess products by public health impact, with stricter measures for high-risk items like vaccines, diagnostic kits, and critical medical supplies

The government is set to implement a risk-based strategy to monitor the quality of medical devices entering the country. According to a report by The Economic Times, the approach will involve randomly selecting samples for quality testing, except in cases involving essential diagnostic kits, where the entire shipment will be tested.

This move comes in response to the growing need for more stringent oversight of imported medical devices to ensure they meet the necessary safety and quality standards.

New guidelines for port officers

A comprehensive document has been issued to assist port officers in making well-informed decisions regarding the quality control of imported medical devices. The guidelines provide a clear framework, emphasising a risk-based model to enhance the effectiveness of inspections at the point of import.

The risk-based approach allows authorities to assess products based on their potential impact on public health, with stricter measures for high-risk items such as vaccines, diagnostic kits, and critical medical supplies.

“The monitoring of the quality of imported drugs, cosmetics, and medical devices is of paramount importance to public health,” states the document. It outlines a three-tier system for inspections, ranging from basic visual checks to full laboratory testing when necessary. This ensures that public health remains a priority while maintaining a practical approach to the regulation of medical imports, the report said.

Three-tier sampling system

The proposed guidelines introduce a structured three-tier sampling system to improve quality assurance. This system includes desktop or visual inspections, field-based tests using Minilab or similar tools, and full laboratory tests for more thorough analysis when required.

The document specifies that any evidence or concerns about product quality will necessitate immediate sampling and testing by port officers.

For specific products, such as vaccines, blood products, condoms, critical diagnostic kits, and re-imported items, 100 per cent of the samples will be sent for testing. This exhaustive testing process for high-priority items aims to prevent substandard or unsafe products from reaching the market, thus safeguarding public health.

By adopting this risk-based approach, the government aims to streamline the quality control process while focusing resources on high-risk imports, ensuring medical devices and diagnostics meet stringent safety standards required to protect citizens.