Japan proposes to speed up medical device approvals
Japan's Ministry of Health, Labor & Welfare (MHLW) is planning to propose a bill to reduce time-frames of Class III medical device approvals. The regulatory change is being proposed with the view that this would reduce time-frames for the approval of generic medical devices and ease the burden on the Pharmaceutical and Medical Device Agency (PMDA), which is an independent body under the health ministry.
In order to speed up the approval process for medical devices, Japan is planning to introduce some changes in the accreditation procedures. News reports emerging from Japan stated that the MHLW will propose a bill that will allow some Class III medical devices to be eligible for the new accreditation procedures. Class III medical devices are those that pose a relatively high risk to the body. Some reports say that this proposed bill will allow around 60 per cent of Class III medical devices to be approved through this procedure.
Another proposal is to replace the permit system for production of medical devices with a registration system. The proposal also admits to the need for a more speedy approval for regenerative medical products made from induced pluripotent stem cells.
The Class III devices, which will be pushed for quicker approvals, will include kidney dialysis machines and generic dental implant products among others. The bill proposes that companies hoping to market such Class III devices will be able to get approvals through private accreditation organisations. This proposal is a departure from the Pharmaceutical Affairs Law of the country that makes it mandatory for all Class III and IV (those that may directly lead to life-theatening conditions) devices to be approved by the PMDA.
The regulatory change is being proposed with the view that this would reduce time-frames for the approval of generic medical devices, while also reducing the burden on the Pharmaceutical and Medical Devices Agency. Class II medical devices, those that are a relatively low risk to the human body, are already approved by a third party body.
The PMDA has been taking measures to resolve the lag of 19 months that exists in the process to approve new medical devices between Japan and the US. The lag consists of 12 months for development and seven months for the review of applications. The reduction in number of Class III devices going through the PMDA should, in theory, increase the focus of this agency to new devices, speeding up approval times.
Japan is not the only country making plans to speed up medical device approval. The FDA has been implementing improvements in its review process to up the speed and predictability. In doing so, the average time it takes to clear a 510(k) improved in 2011 for the first time since 2005. However, it still remains far above the average 90-day review in 2005, with an average of 143 days. As another way to speed up its review process, the FDA is identifying submissions eligible for rapid review, using factors such as level of risk and quality of the submission, with the aim of reducing these review periods to 30 days.
Russia is also expected to bring about changes to its medical device regulatory process in early 2013. In September 2012, the Russian Ministry of Health was working on standardising terminology, updating the classification criteria for medical devices and reviewing the certification process. The Health Minister believes that Russia's involvement in various issues regarding the import/export and manufacture of medical devices will simplify trade and improve product safety.
Those voicing concerns about upping the speed at which medical devices are approved believe that speedy approvals may allow devices that are not safe through the process, potentially causing more product recalls.
With Japan being a relatively large medical device market, it will be interesting to see if the authorities do manage to bring regulatory processes in line with other countries, such as the US. Having an easier and quicker route to get medical devices approved in the country and with the PMDA concentrating on novel or Class IV products, Japan could potentially see a greater level of innovation in the market.