Asia’s changing medical device landscape: navigating regulations and trends

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With its medical device market hitting $44.8 billion this year, China, which has a population of 1.466 billion, claims the third spot worldwide, securing 6.6% of the global medical device market behind Europe (26.4%) and the USA (46.6%). Regulatory developments in China reflect the country’s efforts to enhance the supervision and management of medical devices, attract foreign investment and simplify the regulatory pathway for registering and localising medical devices in its market.

January: accelerated pathway to approval based on real-world evidence. China has introduced new real-world evidence (RWE) elements into the regulatory decision-making process for medical devices. The use of RWE is being explored to support accelerated medical device innovation and market introduction, with an opportunity to gain accelerated approval in the ‘Boao Lecheng Pilot Zone’ in Hainan Province. The Boao Lecheng Real-World Data Research Platform has been set up to connect, structure and standardise data from various sources to support the life cycle evaluation of medical device products, from registration to post-marketing adverse event monitoring. However, challenges such as limited data accessibility, data sharing and concerns about data quality remain. 

July: revised medical device exemption catalogue. In the summer, China’s National Medical Products Administration (NMPA) updated the catalogue of medical devices exempt from clinical evaluation. The new revised catalogue includes a total of 1025 medical devices, with 821 devices categorised as Class II, 202 devices categorised as Class III and 2 devices categorised as both Class II and Class III. A further 21 new devices have also been added, including single-use intracranial traction catheters, anchor balloon dilatation catheters and medical air compressors, among others. The exemption catalogue presents several benefits for medical device manufacturers seeking to introduce products to the Chinese market.

July 2023: new guidelines, including for continuous glucose monitors. As part of the new Medical Device Classification Catalogue, which incorporates advances such as left atrial appendage devices, clipping systems, artificial corneas, disposable absorbable staples, and rotating breast biopsy systems, the Center for Medical Device Evaluation (CMDE) released a series of guidance documents, including ‘Registration Review Guidelines for the Clinical Evaluation Of Ventilators’, ‘Registration Review Guidelines for Continuous Glucose Monitoring Systems’ and ‘Technical Guidelines for the Benefit-Risk Assessment of Medical Device Products’.

August 13: evaluation criteria for targeted software innovations. CMDE’s Announcement No. 23 of 2023 set out various review points for evaluating the performance and clinical assessment of certain types of artificial intelligence (AI) software. This announcement issued guidelines for the clinical evaluation of dental implant systems, including a standardised framework for assessing their clinical performance.

August 20: enhanced oversight of medical device production. In August, the NMPA also issued guidelines for further strengthening the supervision of entrusted production by medical device registrants. These guidelines aim to fully implement the main responsibility of registrants for the quality and safety of medical devices, prevent and control hidden risks in medical device-entrusted production, and strengthen its supervision. 

Just behind China, Japan secures the fourth spot in the $33 billion global medical device market in 2023, with a 4.9% market share. Forecasts by Fitch Solutions predict a 5.9% compound annual growth rate for the Japanese medical device industry from 2021 to 2026. Anticipated single-digit growth until 2027 is driven by the country’s aging population, escalating healthcare needs among older adults, a surge in new technology adoption, and robust demand for advanced medical equipment. 

January 2023: medical labelling overhaul, enhanced guidelines unveiled. At the start of the year, Japan’s Ministry of Health, Labour and Welfare (MHLW) issued revised regulations and implementation guidelines concerning the enforcement of the Pharmaceuticals and Medical Devices (PMD) Act, alongside new barcode labelling laws. The updated implementation guidelines for barcode labelling on medical device containers cover exemptions, data display per device type, the presentation of expiry dates, prescribed barcode formats, and database registration.

May 2023: accelerating regulatory approval of software as a medical device. In the spring, the MHLW issued ‘Guidance for Appropriate and Prompt Approval and Development of Software as a Medical Device (SaMD)’, which encompasses digital therapeutic apps for hypertension, AI-powered colorectal endoscopic diagnostic support software and electrocardiography software for over-the-counter use. This guide streamlines the approval processes for SaMD, allowing flexible application stages while ensuring safety and efficacy from pre-marketing through to post-marketing. Japan has established an integrated contact desk for SaMD inquiries and a dedicated office within the Pharmaceuticals and Medical Device Agency (PMDA). These initiatives are designed to expedite regulatory review, boosting the development and commercialisation of SaMD in Japan. In 2023, 43 SaMD products were approved: a 19% increase on the previous year’s 26 approvals. 

The Association of Southeast Asian Nations (ASEAN), which consists of ten countries – Philippines, Indonesia, Malaysia, Singapore, Thailand, Vietnam, Laos, Myanmar, Cambodia and Brunei – established the ASEAN Medical Device Directive in 2015. This agreement mandates uniform classification criteria for medical devices across the ASEAN region, with the aim of standardising regulations, documents, and implementation among member states. This initiative is creating a unified medical device market that encompasses over 600 million people.

September 2023: Singapore’s healthcare momentum drives medical innovation growth. In the autumn, Singapore’s Health Sciences Authority (HSA) issued comprehensive guidelines outlining essential safety and performance principles for medical devices. These guidelines serve as a blueprint for ensuring adherence to safety and performance standards for medical devices distributed within the city-state. Singapore’s healthcare spending per capita is one of the highest among the ASEAN nations, and is projected to outpace GDP growth due to shifting demographics and an aging population. The country was ranked 10th in the 2022 World Index of Healthcare Innovation. It boasts robust healthcare infrastructure and has emerged as a pivotal global manufacturing hub for cutting-edge medical technologies such as pacemakers, contact lenses and mammography equipment. Statista projects Singapore’s medical device market to hit $818.40 million in 2023, led by the cardiology devices segment at an estimated $119.70 million. Its anticipated growth is an annual increase of 6.48% (CAGR 2023-2028), with an estimated market volume of $1,120.00 million by 2028. 

India is one of the world’s most populous nations, with a population of 1.44 billion in 2023. According to the Department of Commerce under the Ministry of Commerce and Industry, the Indian medical device market includes over 800 manufacturers, 65% of which generate a turnover exceeding $1.5 million, equating to 1.65% of global market share. This year, the sector has amassed a staggering revenue of $11 billion. India is the fourth largest medical device market in Asia after Japan, China, and South Korea. It has an overall 80% import dependency on medical devices from countries such as US, China and Germany. Conversely, a number of key countries such as the US, Germany, China and Brazil import Indian medical devices.

April 2023: National Medical Device Policy unveiled. In the spring, the Indian government unveiled its National Medical Device Policy, aligned with the nation’s vision to bolster the growth and competitiveness of its medical devices sector globally. The goal is an ambitious one: to secure a 10% to 12% share of the global market within the next 25 years while significantly curbing India’s reliance on imports. The government has put in place a liberal policy to encourage foreign direct investment (FDI) in order to boost the Indian medical device market. Between April 2000 and March 2023, FDI inflow in the medical and surgical appliances sector totalled $2.80 billion.

October 2023: expanded medical device regulations bolster quality control. The enforcement of the Medical Device Rules 2017 was extended to all non-notified Class C and Class D medical devices. These regulations are designed to strengthen quality control measures and streamline the manufacturing landscape, catalysed by heightened product demand during the pandemic and by the government’s ‘Make in India’ initiative. 

In 2023, South Korea’s medical device market surged to a record $7.98 billion. The Ministry of Food and Drug Safety (MFDS) reports a 20% surge in imports, which has fuelled this expansion. For the last four years, US medical devices have dominated Korean imports, maintaining a solid market share of 40% to 50%. This growth stems from a heightened focus on patient care and safety, coupled with substantial investments in digital healthcare and the recent adoption of electronic health records (EHR).

Definition of digital health. The Digital Medical Products Act, proposed by the National Assembly in March 2023, defines digital medical products as digital medical devices, digital convergence drugs, and digital medical/health support devices. Among these, digital medical devices are defined as ‘medical devices to which advanced technologies such as intelligent information technology, robot technology, and information and communication technology are applied, and which are used for the purpose of diagnosing and treating diseases.’

Definition of digital therapeutics. The government takes the position that digital therapeutics are a form of ‘medical device’, and the Digital Medical Products Act defines a ‘digital converged drug’ as a product that combines a pharmaceutical product with a digital medical device or a digital medical/health support device, with the primary function of qualifying as a pharmaceutical product. 

The paper showcased attempts to make GPT-4 produce data that supported an unscientific conclusion – in this case, that penetrating keratoplasty had worse patient outcomes than deep anterior lamellar keratoplasty for sufferers of keratoconus, a condition that causes the cornea to thin which can impair vision. Once the desired values were given, the LLM dutifully compiled a database that to an untrained eye would appear perfectly plausible.

Taloni explained that, while the data would fall apart under statistical scrutiny, it didn’t even push the limits of what Chat-GPT can do. “We made a simple prompt […] The reality is that if someone was to create a fake data set, it is unlikely that they would use just one prompt. [If] they find an issue with the data set, they could fix it with consecutive prompts and that is a real problem. 

“There is this sort of tug of war between those who will inevitably try to generate fake data and all of our defensive mechanisms, including statistical tests and possibly software trained by AI.”

The issue will only worsen as the technology becomes more widely adopted too. Indeed, a recent GlobalData survey found that while only 16.1% of respondents from its Hospital Management industry website reported that they were actively using the technology, a further 26.8% said either that they had plans to use it or were exploring its potential use.

Nature worked with two researchers, Jack Wilkinson and Zewen Lu, to examine the dataset using techniques that would commonly be used to screen for authenticity. They found a number of errors including a mismatch of names and sexes of ‘patients’ and lack of a link between pre- and post-operative vision capacity. 

In light of this, Wilkinson, senior lecturer in Biostatistics at the University of Manchester, explained in an interview with Medical Device Network that he was less concerned by AI’s potential to increase fraud.

“I started asking people to generate datasets using GPT and having a look at them to see if they could pass my checks,” he said. “So far, every one I’ve looked at has been pretty poor. To be honest [they] would fall down under even modest scrutiny.” 

He acknowledged fears like those raised by Dr. Taloni about future improvements in AI-generated datasets but ultimately noted that most data fraud is currently done by “low-skill fabricators,” and that “if those people don’t have that knowledge, they don’t know how to prompt Chat-GPT to have it either.”

The problem for Wilkinson is how widespread falsification already is, even without generative AI.