TOKYO — Seeking to put more ventilators into hospitals as fast as possible for coronavirus patients, Japanese regulators are streamlining quality screening for carmakers and other newcomers seeking to enter the field.
Initial on-site checks will be deferred for ventilators assembled by nonmedical manufacturers in partnership with ventilator producers, the Ministry of Health, Labor and Welfare announced Monday. So the process will be completed in days via document-based reviews, instead of the four months or so typically needed.
Quality checks under the law on medical device safety will still be carried out later. The hope is that the accelerated process will encourage manufacturers of automobiles, electrical machinery and other products to team up with existing ventilator makers and repurpose factories.
Facing a potential shortage, Japanese Prime Minister Shinzo Abe has said the government will initially “secure 15,000 ventilators and will further boost production.”
Japan’s auto industry has offered to provide manufacturing know-how to help ramp up ventilator production but no carmaker has come forward to start actual production. Since existing medical equipment makers alone will not be able to meet surging demand, the government hopes to encourage cross-industry partnerships.
For manufacturers producing only ventilator parts, the usual required administrative procedures have already been waived, the ministry said.
The U.S. has already eased restrictions on materials and parts for ventilators to encourage entry by nonmedical manufacturers, with General Motors planning to start shipments by June.