The International Medical Device Regulators Forum released updates on regulatory works in progress in member countries following its March 20-22 IMDRF meeting in Shanghai.
Russia reported that it established a new medical device quality management system that was developed for the Eurasian Economic Union, which includes Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia. The main provisions require QMS clearance before pre-market approval for sterile and higher-risk devices — and manufacturers will be inspected every three years.
Brazil granted Anvisa new authority to conduct GMP inspections of device manufacturing facilities outside the country. The risk-based inspections will depend on the complexity of the manufacturing process, the potential health risk and the compliance history of the manufacturer.
Audit reports issued within the framework of the Medical Device Single Audit Program (MDSAP) will be used to assess GMP compliance and to grant GMP certificates.
Anvisa has recognized 13 auditing organizations and Brazil has granted 63 GMP certificates using MDSAP audit reports to date.
Brazil also introduced a public consultation on a proposal for unique device identification codes to be included on patient implant cards for cardiovascular stents, and hip and knee implants.
Japan Targets Real-World Data
Japan’s Pharmaceuticals and Medical Devices Agency is establishing a Regulatory Science Center to collect real-world data to better inform the quality of device reviews and post-market safety measures.
Japan reported that the first medical device was approved using its new Sakigake priority review pathway in December 2017. The approved device was a titanium bridge for adduction-type spasmodic dysphonia. The device was approved in six months.
Korea’s Ministry of Food and Drug Safety is implementing a Special Act for Innovative Devices that will include 3D-printed devices, medical devices that use artificial intelligence and big data, genetic testing devices, and intelligent robots, among other innovative products.
The act’s main features include an expedited review process, a customized safety management system, technical support for clinical trials and capacity building.
Korea has also introduced an IVD Act to address the unique characteristics of IVDs. For example, it provides for a simultaneous review system for companion diagnostics and drugs. It establishes a clinical laboratory accreditation program and approval system for IVDs that allows for advanced genetic testing following accreditation. The approval system is simplified for IVDs by combining IVD reagents, equipment and software as one system for approval.
In December, Korea also introduced new guidelines on 3D printed medical devices.
Australia also updated the IMDRF management committee on its regulatory reforms. The country recently introduced an expedited review process for novel devices, and it is developing guidance for using data from comparable overseas regulators for approval of medical devices in Australia.
As part of that process, Australia will designate conformity assessment bodies in Australia. Previously, the country relied on EU notified bodies.
Singapore is implementing a system similar to Australia’s whereby marketing authorization from certain reference regulatory agencies will suffice for marketing authorization in Singapore. The reference regulators are Australia’s TGA, the EMA, Health Canada, Japan’s PMDA and the U.S. FDA.
The city-state is implementing legislation covering telehealth products and regulatory requirements for stand-alone software and mobile applications. It expects to release guidance in 2018 covering essential principles for safety and performance of medical devices, labeling for devices, device registration and change notification.
China reported that it is improving the coding requirements of medical devices, and the CFDA released a consultation on rules for unique device identifiers for public comment.
CFDA released guidances that cover system software and network guidelines for medical devices. It is currently developing guidance on security technology reviews for medical devices, technology reviews of mobile medical devices and technology reviews of medical device software.