KITCHENER -- A former advisor on the SARS Commission says they recommended the Ontario government set up a NIOSH equivalent in Canada more than a decade ago.

Millions of PPE products are still sitting in a Cambridge facility as the company waits for certification from an American regulatory body.

There have been delays with the National Institute for Occupational Safety and Health (NIOSH) certifying international products.

"It's just astounding that Canada is in this terrible position," said Mario Possamai, a former senior advisor on the commission.

Eclipse Innovations started making respirators during the pandemic, but it's still waiting for certification. It's producing nearly 200,000 products a day.

"If manufacturers can't sell their product now, they are not going to be around," CEO Steve Mai said. "If they aren't around, there's nothing to certify."

Possamai said the commission recommended the province should set up an equivalent of NIOSH in 2006, but it never happened.

"When Justice Campbell's recommendations were not implemented, we lost a huge opportunity," he said. "We lost opportunity for companies like Eclipse to enter the market in a timely fashion."

"We have the companies who are willing to pivot and manufacture those masks," said France Gelinas, NDP Health Critic. "They are there, we need them and yet, because of red tape, we can't access them. It just infuriates me."

CTV News reached out to the Ministry of Health for comment, but had not received a response by 6 p.m.

Health Canada said last week the company's devices are authorized for import or sale in Canada through an interim order. It will likely extend that order to the fall, then introduce regulatory changes.

However, Mai said there's still roadblocks without the NIOSH stamp of approval.

"Both the province and the federal governments have to get on board and they have to be the glue that sticks these problems together," Mai said.

Production continues at the Cambridge facility while Mai waits for an update.