The government said it would promote the growth of in vitro diagnostic medical devices such as diagnostic reagents for the new coronavirus with the new law taking effect this month.
The Ministry of Food and Drug Safety Ministry said the “In Vitro Diagnostic Medical Device Act,” legislated for better management of in vitro diagnostic devices, took effect on Friday.
As the healthcare paradigm is shifting from treatment to prevention, including diagnosis, the government separated the In Vitro Diagnostic Medical Devices Act from the Medical Devices Act on April 30, 2019, to reflect the specific needs for in vitro diagnostic devices used with samples such as blood and urine.
The In Vitro Diagnostic Medical Devices Act and subordinate ordinances classify devices according to the impact of their diagnostic results on public health, separate and manage the classification, and strengthen measures for clinical performance testing.
The regulator will classify in vitro diagnostic medical devices into four, from Grade 4 to Grade 1. Grade 4 products will be those requiring the highest safety control. The government will decide the classification of a product based on the potential risk in its use on individuals or the public health.
The regulator will give “permit” to Grade 3 and 4 devices, “certification” to Grade 2, and “report” to Grade 1. For devices requiring permits and certification, the government will make analytic and clinical performance tests more specific. It has categorized devices for polymerase chain reaction (PCR) and antibody tests for Covid-19 as Grade 3.
If a company wishes to report minor changes that do not affect the safety and efficacy of the product, the government will simplify the process for approval changes, it said. The company will be allowed to report the changes later so that it can accelerate the market release of the product, the government said.
A medical institute, a blood supplier, a medical school, or a sample testing laboratory will designate where the company should conduct a clinical performance test. A clinical performance test requires approval by the regulator’s review committee in advance, and an executioner of the clinical performance test should receive over eight hours of professional education per year.
Besides, the government will certify a medical institution or a genetic testing institution, whether it is available for next-generation sequencing in vitro diagnostic testing, and exempt in vitro diagnostic medical devices used for certified testing from approval procedures.