China Expands List Of Devices Exempted From Clinical Trials
By Jof Enriquez,
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The Chinese Food and Drug Administration (CFDA) has released an expanded list of medical devices that will not be required to satisfy stringent clinical trial requirements.
Companies entering China may still find the overall registration process to be more complicated and time-consuming than in other countries, notes WILDDESIGN’S Miriam Dabrowa. Besides lead regulator CFDA, sponsors need to deal with other government bodies, such as the Center for Medical Device Evaluation (CMDE) and General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) to satisfy regulatory requirements.
The minimum time period to obtain product registration is about 14 months, according to Dabrowa. Advanced devices requiring clinical trials will take even longer, and approval in the country of origin is required before registration in China can take place.
After more than a decade, however, Chinese authorities announced in March new medical device clinical trial guidelines for sponsors intending to launch devices in the country. The updated guidance, which took effect June 1, 2016, brings clarity to both local and multinational device manufacturers operating in the country.
Chinese regulators in May had proposed to exempt more devices, and the recent announcement from CFDA confirms that there are now 276 Class II devices deemed exempted, including assisted reproduction products, plastic surgery devices, and interventional devices, as well as 92 Class III devices exempted, including blood processing and bypass equipment, reports Emergo.
The latest device exemptions took effect on Sept. 30, 2016.
These devices no longer have to satisfy strict clinical trial requirements as set forth in the current CFDA medical device approval process to enter the burgeoning Chinese market. With the streamlining of device approvals, the government aims to encourage local device innovation and facilitate the entry of foreign companies to satisfy growing healthcare demand.
China has taken significant strides to improve its healthcare system over the past few years, notes Decision Resources Group's John Pong. The Chinese government has invested over RMB $2.2 trillion (USD $359 billion) in the past five years to improve China’s device regulations and harmonize them with regulations used overseas, such as in the United States, Japan, and the European Union (EU).