Treat the China Food and Drug Administration (formerly known as the SFDA) with the same sense of priority and urgency as you would its U.S. counterpart - the Food and Drug Administration.
Whitney has seen interest in China spike over the last five years as the number of medical device and diagnostic companies seeking regulatory help from her company have doublde or tripled in that time period.
But many times she has notices that companies lose the sense of urgency and priority as efforts to get the product cleared/approved in the U.S. get precedence.
"When it comes to product approval, everything that supports FDA approval becomes top priority and the China approval becomes less important," Whitney said. "But I feel that China represents a huge market for everybody. You should treat it the same as a new market release in the U.S. and keep it as a top priority for engineering, for marketing and regulatory of course."
Whitney explained that sometimes companies look at the time difference between the two countries and decide that responding to questions from the Chinese reviewer can wait till later.
"I hate to say that but when something happens at the other end of the world, you sort of say, 'I can do it at the end of the day' and you actually run out of time and by the end of the day forget about it," Whitney said. "The Chinese registration process is very demanding, [On top of that] you have the time difference, you have the language differences and the difficulties double and triple, so you can't just say I will do it tomorrow because tomorrow there are other things to do."
The other piece of advice she has for medical device and diagnostic companies looking to navigate the regulatory process in China is to do proper due diligence. In many cases, companies jump in head first without realizing that the rules may in fact prevent registration for their particular product.
Finding out about such rules is not easy either because the regualtory requirements can be fuzzy, which leads to confusion.
"A Chinese saying goes, 'You have to cross the river by finding the stones,' so you really have to figure out what is really required," she said.
When navigating the regulatory and registration process, she counseled the importance of being responsive to reviewers requests.
"Even if you know what the reviewer is asking is wrong, you have an obligation to respond," she said.
Sometimes, though, the reviewer simply doesn't know as opposed being skeptical or suspicous of the product under review. Whitney recalled the time when a reviewer looking at a user manual was confused by the term "in-office" use. She explained yo the reviewer that the product is meant to be used inside a physician's office as opposed to at home.
"The language differences can lead to quesitons," she said. "So I tell my staff, we are not just messengers between the reviewers and the manufacturer. We really need to understand what is being requested."
Whitney will be one of the speakers at a session of the IVD Business Strategy Conference, San Diego, Nov.6-8, discussing ways to oversome regulatory challenged for in-vitro diagnostic companies seeking to commercialize in BRIC Countries.