Asia Medtech Reg Discussions: COVID-19 Is A Golden Moment For Medtech And Governments To Learn How To Deal With Future Crises
The fast-tracking of COVID-19 relevant health care products should be a blueprint for a systemic approach to matching innovation with clinical needs, say Asian medtech regulatory experts.
The experiences of COVID-19 within the medtech industry have varied from company to company and from country to country. Asia was hardest hit by rising infections in the early months of 2020, but recovered more quickly than other regions and countries following swift action.
In fall 2020, Medtech Insight moderated a panel of regional regulatory experts to gauge their thoughts and expectations of national control efforts, and what stakeholders – industry and governments included – must learn to ensure future health care crises are handled more efficiently.
“How has COVID-19 changed the medtech industry in Singapore and ASEAN” was the theme for the panel discussion jointly held by Asia Regulatory Professional Association (ARPA) and the Singapore Manufacturing Federation Medical Technology Interest Group (SMF MTIG). Company representatives, industry and professional associations and the regulatory consultancy, ARQon, were also on the panel.
Among those participating were Jack Wong, founder of ARPA, and Ng Xi Yun, QARA manager at EndoMaster Pte Ltd and chair of the new Singapore Chapter of ARPA. The official opening of the Singapore Chapter was announced as a preface to the main discussion, which is reported below.
I would add that, because of the very tight timelines that must be adhered to under COVID-19, the regulators need to be creative and develop very express pathways for the approval of some products, be they medical devices or pharmaceuticals. These pathways will be very important reference points in the future, in the case where we have another crisis.
It was good to have a lot of products available from a safety point of view. However, there were cases of sub-standard products that were not authorized, including masks, getting into circulation. And it was down to the public to differentiate between compliant and non-compliant products. The aim must be to source products from reliable sources, based on good, transparent information. For instance, lists of approved COVID-19 tests were published on local health care regulators’ websites, including those in Singapore and the Philippines.
In terms of manufacturing COVID-19 products, some non-device manufacturers ̶ shipping companies for instance ̶ were able to convert their operations and help out in product manufacturing. Some start-up companies also tried to convert their technologies and output, from non-COVID to COVID-related respiratory products, for example.
And regarding software-related applications, companies should take this opportunity to see what changes they can make to their products, and add new intended purposes to products to help meet the public needs.
I think lot of governments and officials are now willing to approach industry, talk to companies and seek justification why certain products should be fast-tracked. A similar crisis might happen again. Normally, it can take one year to approve a product; now, with justification, approvals are happening within a month or even less. We are in a “golden moment,” and the good thing is that governments are willing to listen about COVID-19 needs, and learn from the situation.
We can’t meet face to face, but via digital platforms that allow industry and governments to come together when problems arise. Many companies have switched focus to COVID-related opportunities. Some companies, either intentionally or by chance, realized that their product had a COVID-19 function, and went for it, creating a new indication, or “new intended use.”
For instance, in the Philippines, work on device submissions was held up for a few months, but that restarted [as of late September]. At this point, companies registering a class A (low risk) device applications will not require a Certificate of Exemption (COE).
Myanmar entered into lockdown in September, and the ministry of health decided on special regulatory rules, but the regulator still had not implemented them [by late September], meaning industry could not file submissions during the lockdown.
Malaysia in lockdown was still doing device product reviews, and there were approvals ongoing. New guidance was issued for post-market surveillance, including a new form on which to record adverse events. New device advertising requirements have been delayed until 2021.
Vietnam is planning to implement new device price control rules, with the relevant text being drafted at present. Indonesia’s e-Catalogue will be back in use soon, having not been available to use for the past year. Indonesia has reduced its timeline for approvals. The Thai medtech industry is having briefings from the Thailand FDA about the new device regulation, which has not yet come into use. Industry has been eager for updates on when to submit applications under the new regulation.
Separate fast tracks, requiring specific reviews, are also in place. Their requirements are the same as for all products, but they put a real focus on the review and on a reduction in approval time. And one other important mechanism is “regulatory reliance,” i.e. using the approvals from other reputable regulatory agencies as acceptable proof of a product’s quality. The Philippines, Singapore and Malaysia have utilized this route. These are the most important learnings for regulators during this period.
On the negative side, there was a proliferation of unregistered or not-notified PPE, especially in May, June and July in the country. This is one thing the FDA has been trying to control and in fact highlighted on its website. The main source was online outlets. Online sale are in the process of being regulated.
In the past, it was purely medical logistics supplies. Now it is also about clean rooms, sterile packaging, sterilization and outsourcing. But many brand owners don’t want to go through these tedious and time consuming processes that need special skill sets, and are very costly. Outsourcing is what they want to do, a business need that Mentor Media serves.
A lot of customers prefer to use pre-validated medical packaging. But new product lines still need the requirements of a cleanroom, which is why outsourcing is the trend. There are commercial reasons as well. Global markets need to adapt. Today we have COVID-19, but we need to be nimble to change, and brand owners do too.
Chronic care and critical care are doing fairly well, as governments and hospitals are preparing for worst case scenarios and have been stocking up to ensure that there will not be a situation where they run out of supplies. Companies involved in PPE are doing really well, with masks rising in price. Singapore has encouraged local companies to source more masks. The Health Sciences Authority (HSA) requires notification of import quantities, and in many cases, these can come into the country without registration.
Over this period, a major pain point has been supply chain and logistics, and whether goods get held up at customs. We need to ensure that deliveries can still take place and that hospitals still have products. COVID-19 heralded much innovation and led to business pivots. Industry took a real hard look at digitization and automation, and how to innovate their products.
Business teams were all in one location for the first time – and that helped drive lot of innovative ideas. Use of Teams and Zoom platforms allowed us to stay in contact with customers and keep up some level of communication, although it’s not the best option.
One of the positives to come out of COVID-19 was that companies were able to see how much they could streamline processes, or drive operational excellence to ensure business sustainability. These are some of the key things that we discovered along the way, and these are the silver linings of COVID-19.