The recent International Medical Device Regulators Forum (IMDRF) meeting in Beijing featured presentations by international regulatory authorities on their significant regulatory changes.
Chinese regulators highlighted recent reforms aimed at encouraging innovation while at the same time making review processes more efficient. One such provision will fast-track reviews for innovative devices that are new to the country. The new review procedure replaced the earlier green channel that was launched in 2014.
Deep reforms were made to China’s clinical trials procedures that are expected to make conducting trials in China more attractive. China is now accepting overseas clinical trial data, and it has simplified its device renewal process.
China’s Drug Administration amended its regulations to exempt some Class II devices from listing. It also prohibited the sale of used devices.
To strengthen supervision, it established a professional inspectorate and added penalties for responsible persons that act as legal representatives for foreign device companies operating in the country. CDA also defined the obligations of agents for those imported devices.
To beef up compliance, CDA established a more centralized adverse event reporting mechanism that includes a process for continuous and periodic risk analysis. Under the new process, China’s Ministry of Health will re-evaluate whether certain devices represent new risks and what action should be taken.
Japan Considers Regulatory Overhaul
It’s been more than five years since Japan amended its Pharmaceutical Affairs Act, which also governs devices, and a new committee is considering areas that need to be revised. Topics under discussion are the approval framework and quality management system audits.
Japan has revised its good post-marketing study practices to incorporate a reliability standard for conducting observational studies using databases such as its MID-NET medical information database network.
The Pharmaceuticals and Medical Devices Agency’s Science Board recently published a paper on artificial intelligence and considerations for reviewing devices that incorporate AI technology. A PMDA consultation will evaluate points for diagnostic imaging products incorporating AI technologies.
Japan sees six significant areas for AI adoption: genomic medicine, diagnostic imaging, clinical decision support, drug development, dementia care and surgery support.
Japan’s Ministry of Health, Labor and Welfare also recently issued guidance on cybersecurity for medical devices.
Brazil Launches National Implant Registry
Brazil’s ANVISA launched a national implant registry that will compile voluntary registrations on surgical procedures for hip and knee prostheses and coronary stents. The registry will initially be voluntary, but it will likely become compulsory and may be expanded to include other implantable devices.
Brazil is also requiring unique device identifiers to be placed on patient cards of cardiovascular stents, and hip and knee prostheses.
In addition, blood glucose monitoring devices were required to be compliant with ISO 15197/2013 by November 2018, or they would be removed from the market.
Brazil’s regulators also reported on MDSAP progress to date, reporting that 127 MDSAP audits have been conducted and ANVISA has recognized 13 auditing organizations.
ANVISA also has a consultation process underway on replacing its current registration process for low-risk devices with a notification pathway that would no longer require premarket reviews (IDDM, May 21).
Australia Unveils Expedited Reviews
Australia’s TGA has introduced an expedited review process for certain novel devices under new regulations aimed at getting innovative devices to market faster.
The TGA said it will accept approvals from comparable overseas regulators, which initially include the European Union, the U.S., Canada and Japan. Medical Device Single Audit Program (MDSAP) certification is also required as quality management system evidence, the agency said.
Australia is aligning its regulations to be on par with Europe, and the TGA followed the EU’s lead on up-classification of surgical mesh and requiring patient information cards for implantable devices (IDDM, Aug. 13).
The agency is also strengthening postmarket monitoring and is integrating IMDRF adverse event terminology and codes into its databases.