Govt Explores random testing of imported Medical Devices

The government is considering overseeing the quality of imported medical devices through a risk-based method in which random samples will be selected for quality testing, with entire shipments of critical diagnostic kits being tested.

The government has released a document to help port officers make decisions on monitoring port quality during imports using a risk-based approach.

"The monitoring of quality of the imported drugs, cosmetics and medical devices is of paramount importance to the public health," it said.

"This guidance document has been prepared for the Port Officer to implement a risk-based approach at various levels for monitoring the quality of the imported consignments to provide high degree of assurance for the safety of public health," it further said.

This recommendation suggests using a three-tiered risk-based strategy for sampling, involving desktop inspection/visual inspection, field-based testing with tools like the Minilab, and laboratory testing if necessary.

"It is recommended that the testing shall be considered as final for taking action," it said.

In the event that the Port officer of CDSCO or custom officer receives information or evidence indicating questionable quality of a product, it must be sampled and tested as per the document. All items such as vaccines, blood products, critical diagnostic kits, condoms, and re-import cases will have 100% of samples sent for testing.