China has been removing legal challenges for foreign brands to enter its lucrative domestic market, like compulsory animal tests. But China lawyer Mark Schaub warns there are still barriers in place and might stop fast market entry, he tells in Vogue. He lists two major ones.
One challenge is obtaining the certification of the manufacturing quality management system (QMS) for each manufacturer used for a product for the China market. The QMS is released by the country where the manufacturer is based, but it’s still not clear which jurisdictions the China National Medical Product Administration (NMPA) will recognise. Mark Schaub, international partner at King & Wood Mallesons, believes that France, Japan, South Korea and Spain will be the most likely countries at first. Other jurisdictions, especially those that are experiencing political friction with China, may face a longer wait. “It’s very unlikely that Australia will be recognised in the short-term,” he says…
Another hurdle is the appointment of a so-called Domestic Responsible Agent, necessary for all brands seeking registration with the NMPA. The agent is liable for safety issues related to imported products. The new provisions create tougher potential liabilities for the agent, including fines, employment bans and criminal liability. That makes it harder for brands to find a third party willing to take on the responsibility, says Schaub. “If there is a recall, the domestic responsible agent may be the first in the firing line, given that the company is protected by being overseas,” he notes.
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