Asia Pacific Medtech: Regulatory updates to have on your radar in 2024

With Asia continuing to be one of the major regions for innovative medical devices and pharmaceutical products, a recent APACMed town hall meeting explored the Medtech regulatory outlook for the Asia Pacific region in 2024, covering development updates in digital health and telemedicine.  Here are some of my takeaways from the meeting, outlining the key Medtech regulatory updates to be aware of across the following countries: 

Australia

The Therapeutic Goods Administration (TGA) compliance and enforcement priorities for 2023-24, include nicotine vaping products, medicinal cannabis, psilocybin and MDMA, etc. The Health Technology Assessment Policy and Methods Review seeks to identify features of health technology assessment that are working effectively or could be barriers to earliest possible equitable access, or detract from person-centeredness and create perverse incentives. 

China

The National Healthcare Security Administration (NHSA) plans to standardize medical consumables reimbursement. Provincial HSAs will establish a reimbursable consumable list (similar to the National Reimbursable Drug List) and define reimbursement levels based on VBP-winning prices and HSA-negotiated prices (applicable to high value medical consumables). For example, Beijing HSA carved out innovative devices from DRG reimbursement mechanism in July 2022, and Shanghai announced a multi-party payment scheme for innovative devices in July 2023. 

India

The ‘Made-in-India’ campaign continues to be important on the government agenda. Investments in Medtech manufacturing are encouraged in the recently launched medical device parks and Performance Linked Incentives are extended in support of investments and spur growth. In addition, India’s Medical Device Policy 2023 is focused on the growth strategies for the Medtech sector and aims to reach a $50 billion market in the next five years. The new Drug, Medical Device and Cosmetic Bill 2023 aims to create separate governing mechanism for the medical devices and procedures to ensure streamlined regulatory processes, promote transparency through digitalization, encourage innovation and ease of doing business.

Indonesia

The Indonesian government issued the “Omnibus Health Law” (Law No. 17 of 2023 on Health) in August 2023, which contains incentives for pharma and medical device manufacturers to perform research, development and innovation activities in Indonesia and use local raw materials. The Omnibus Health Law also expects to provide detailed stipulations on telemedicine practice and foreign medical personnel practicing in Indonesia, as well as grant the central government the ability to regulate and control the prices of drugs and medical devices. 

Japan

In March 2023, the Ministry of Health, Labour and Welfare released revised guidelines relating to software as a medical device (SaMD) to give more clarity on the borderline between SaMD and non-SaMD and to further the launch of innovative healthcare software. 

Singapore

In June 2023, the Health Sciences Authority received the Stringent Regulatory Authority (SRA) recognition. This allows for In Vitro Diagnostic (IVDs) that have been evaluated and approved by the HSA to obtain faster evaluation for WHO prequalification, which reduces the time required for companies to register high-risk IVD products (Class C and D) in other countries and enables IVD manufacturers accelerated access to global markets. 

South Korea

In December 2023, the National Assembly passed the new Digital Medical Product Act which will govern the regulatory lifecycle of digital medical products, including clinical trials, approval and post-marketing management. The Act also aims to evaluate the safety and efficacy of these products incorporating digital technologies (e.g., AI) and digital characteristics (e.g., network connectivity) more efficiently and systematically. Additionally, similar to the U.S. Sunshine Act, the Pharmaceutical Affairs Act and Medical Devices Act require medical device and pharmaceutical companies to disclose details of any economic benefits provided. The first disclosure of expenditure reports is expected to occur from or around August 2024. 

Thailand

The Ministry of Public Health’s (MoPH) E-Health Strategy aims to drive transformative healthcare through technology and prioritizing accessibility, quality service, and operational efficiency. Digital health technologies are regulated by three key legislations: Medical Device Act B.E. 2551 (A.D. 2008), Personal Data Protection Act B.E. 2562 (A.D. 2019), and National Cyber Security Act B.E. 2562 (A.D. 2019). 

Vietnam

Vietnam emphasizes smart healthcare through government decisions and plans to leverage technology for service improvement with legislative support, such as Circular 49, for promoting telemedicine activities and outlining licensing and technical requirements. Digital Health initiatives continue to grow and develop in Vietnam post-pandemic, and there is an expectation of evolving rules and regulations regarding digital health to better fit the evolving digital technologies used in the healthcare sector.

Conclusion

Digital health and telemedicine experienced booming growth during and after the pandemic, and corresponding regulations have been frequently updated in recent years. It is crucial for medical device and pharmaceutical companies and investors to keep abreast of the rapid regulatory changes and developments when making business decisions in Asia. 

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