Here We Go Again: Japan’s Red Tape Delays Manufacturing Face Masks

Chino, Japan, April 12—This is a story I have told again and again and again, and it’s the reason why Japan’s manufacturing, much of it having drifted to China save autos and a handful of high-tech segments, won’t come back home for a long time: Earlier in April, Toyota Motor Corp., Sharp Corp., and a handful of Japanese non-medical companies said they would start manufacturing surgical and consumer-use face masks. But the manufacturing pace and shipment remains stagnant not necessarily because those non-medical supply companies are not familiar with manufacturing processes but because of JAPANESE GOVERNMENT RED TAPE.
It takes several months before companies manufacture or import medical devices that concern human health. Excluding scissors, scalpels, pin sets and other devices that are deemed to have limited risks to human health, all other devices must meet safety risk and quality clearance of the Ministry of Health, Labor and Welfare as quasi-pharmaceutical devices as well local Japanese municipalities under the Pharmaceutical and Medical Devices Law.
In addition to clearing government regulations, facial mask products need to carry labeling on quality and materials, country of manufacture, purpose of use such as for pollen shielding or for surgical.
So it was not a numerical error when Toyota announced on March 7 that the company would produce 500-600 face shields a week – not 500,000 to 600,000. Toyota didn’t say when it will start manufacturing and shipping the products. Sharp Corp. has claimed that it began shipping consumer-grade face masks from March 31 but consumers reported not sighting the products at all.
Obtaining government clearance for manufacturing ventilators would take at least 10 months, the Japanese business newspaper Nihon Keizai April 10 reported, blaming the long lead time to government red tape. It’s the reason why Toyota and other automakers did not ask suppliers to manufacture ventilators despite growing demand for them to save lives of coronavirus stricken patients, it said.
In the meanwhile, Japanese media said Prime Minister Abe tweeted on his twitter post of his video relaxing in his residence on April 11 to the tune of the singer songwriter, Gen Hoshino.

–By Toshio Aritake

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