In a quiet announcement from China’s Ministry of Finance National Development and Reform Commission last week, the Chinese government cancelled an array of administrative charges – including for drug and medical deice testing. Already type testing centres are cancelling charges, but there are traps here which may slow down testing processes.
Product registration in China requires the conduct of local product “Type Testing” in CFDA controlled laboratories. These processes add to the time and cost of regulatory approval in Australia.
The Commission announced the cancellation of a raft of fees for “administrative processes”. Amongst the breaks on marriage licenses and Yangtze river gravel mining fees were cancellation of testing fees for drugs and devices, as well as cancellation of registration fees for veterinary medicines and import license fees for anaesthetics and psychotropic medicines.
Two type test centres in Shanghai and Guangzhou have already announced intent to cancel Type testing fees and others are expected to follow soon.
The cancellation of the fees removes costs for sure – For example an electrical safety type test for an active device can cost up to 30,000 RMB ($US4,350) in testing fees.
But as they say – be careful what you wish for. Current arrangements at most test centres include bonus incentive payments to Technicians for efficient processing of tests and some test centres even offer an option of an express service fee. The likely impact of this will be less urgency in testing, so slower processing. And in the absence of a standard fee payment process, the option to pay an express service top up fee may disappear.
Type testing always requires active management – it’s essential to support the test centre with expert technical resources to ensure things proceed smoothly. That usually translates to the need to send people to the test centre at the time your testing is done. This will be even more important now.
Seeking China market access? We offer a full medical device and IVD service through our bilingual experts based in our Beijing offices. We support strategy, pre-consultations, type testing, clinical trials and clinical predicate evaluation reports, expert biocompatibility risk assessments, product registration filings and reimbursement. Contact us: Email email@example.com or call +61 2 9906 2984 for a confidential, no obligation discussion of your needs.