When it’s all going wrong you need a competent local friend. A large US multinational had entered the Chinese market by engaging a local distributor. The distributor had offered regulatory services at no cost to win the contract and in turn engaged a low cost local provider who effected a smooth approval and then departed the scene. When renewal came due 3 years later multiple deficiencies where exposed in the registration record including inaccurate details of manufacturers and certifications. The manufacturer faced loss of registration and Chinese market access, inability to import product to fill current orders and possible regulatory action. Brandwood Biomedical senior leadership were able to engage with senior reviewers at CFDA and negotiate a path forward to correction of the registration record and achieve a renewal within deadline and no interruption to supply.
There are two lessons here. First: be wary of free or very cheap regulatory add-ons from international distributors. Offers that are too good to be true almost always are…. The peace of mind from the support of in a competent and independent regulatory representative is priceless. Second, if you are the victim of questionable past practices, then it’s time to take action and deal directly with the regulator at the right level to fix the problem, fast.
Brandwood Biomedical offers direct local representative services in Australia/NZ, China and can refer you to selected trusted partners in North America, Europe and South East and North Asia.
Need a local representative or need help to clean up a mess? Contact Us for a free, no obligation appraisal