Tracking and staying up-to-date on the latest developments affecting medical device translation regulations in countries like China, Malaysia and Singapore — and indeed across all of Asia — can become a full time job. Luckily, medical translation services like GlobalVision employ attentive regional experts who keep their fingers on the regulatory pulse of the medical device industry in Asia, and beyond.
For medical device manufacturers working with a Chinese document translation service or a Malaysia translation service, or perhaps setting up shop in Singapore, here are three recent medical device directive updates you should be aware of — along with a few choice reasons as to why China, Malaysia and Singapore are so appealing to the medical device industry in the first place.
Registering Medical Devices Electronically in China
When commissioning life science translations for your medical products (and using a Chinese document translation service to do so) with the aim of cracking China’s massive biotech healthcare markets, you’re going to have to deal with the China Food and Drug Administration (CFDA) at some point.
With the Chinese government pushing its “Made in China 2025” strategy, opportunity (and competition) in mainland China’s healthcare sector is set to explode. Fortunately for medical device firms, according to a report from the Emergo consultancy group, the CFDA “plans to ease certain requirements for registration renewals and clinical trial application processes.”
While the nuts and bolts of how these medical device registration reforms are always subject to change, this new approach by the CFDA basically hinges on implementing a resilient medical device electronic registration submission system. A comprehensive electronic submission platform with less stringent medical device and IVD (in vitro diagnostic products) submission requirements should facilitate quicker entrance into the Chinese market. Plans to reduce the clinical trial application requirements, as well as removing the product analysis report delivery requirements when renewing device approvals should also make the registration process easier to handle.
Once the CFDA gets its online Regulated Product Submission System fine-tuned, Chinese document translation services will be able to translate medical device materials, then conveniently upload all of their translated documents onto a single website, thereby simplifying the device approval and renewal processes considerably.
Adapting to Malaysia’s New Medical Device Regulations
Malaysia, which imports more than half a billion dollars worth of medical devices every year, according to Export.gov, and also deals with more than two billion U.S. dollars worth of trade surrounding the medical device industry in general, is a business destination showing up on every manufacturer’s commercial radar.
Malaysia translation services are preparing for a big change this summer. As of July 1, 2018, rather than simply make use of Acknowledgment Letters when selling medical devices in Malaysia, companies will now have to acquire full registration as outlined by the Malaysian Medical Device Authority (MDA).
Failure to switch over to the new regulatory scheme would be a big (and illegal) business no-no. We can’t stress enough the need for medical device companies — with the help of a qualified medical translation service — to dive headfirst into the MDA registration process as soon as possible, if they haven’t done so already. No company ever wants to run afoul of the local regulatory bodies.
Regulating Medical Devices in Singapore
Singapore, which has one of the world’s highest ranked healthcare systems, is a great destination for the medical device sector. And with Singapore’s desire to “facilitate faster access for certain lower risk medical devices and standalone mobile applications,” opportunities in Singapore’s medical device field abound.
Singapore’s Health Sciences Authority (HSA) wants to foster the growth of “different operational and emerging business models in the medical device industry,” while cheering on innovations that also pay attention to safeguarding “consumer health and safety” at the same time. Some of the key components of the enhanced regulatory legislation are as follows:
- In order to facilitate faster access to the Singaporean market for lower-risk Class A sterile devices like “sterile examination gloves and sterile intravenous sets,” the previous requirement to register these devices with the HSA will now be waved.
- Although importers and manufacturers will no longer be subject to registration requirements for Class A sterile devices, they will still “be required to list all their Class A medical devices on the public online Class A database,” allowing the HSA to continue its close post-market safety monitoring.
- Class B devices that presently qualify for the HSA’s expedited registration route will now be able to skip the line and apply for the immediate registration route if they can prove compliance with the following: No safety issues associated with the device globally, and two independent regulatory agencies or one reference agency’s approval plus three years of marketing history. According to the HSA, “75% of Class B applications will be granted immediate market access” via this process.
- In regards to Class B and C standalone mobile medical apps, such as “standalone application for calculation of insulin dosage, or live monitoring of ECG for cardiac patients,” if the item in question has already been approved by “at least one reference market regulator” (e.g. the FDA in the U.S., or Japan’s PMDA) with zero safety issues reported globally, the device(s) will be “eligible for immediate market access under the immediate registration route.”
Changes to regional medical device regulations, which of course affect how medical device translation services operate, need to be continuously monitored for policy updates and amendments (big and small) in order to guarantee your medical device(s) a competitive place in local healthcare markets. Medical translation services that understand different regional medical device regulation requirements can help companies translate and prep their medical device translations for submission, enabling them to successfully navigate tricky regulatory waters, and sell their medical wares overseas.
Read our whitepaper 5 Case Studies in Medical Translation Service, a 10 minute read that will help you understand some of the challenges involved in Asia and elsewhere and how to overcome them! You can also register to attend the 15 minute free healthcare Translation webinar.