The upcoming compliance deadlines for the European Union Medical Device Regulation (EU MDR) have dominated conversations about the increasingly complex regulatory landscape device manufacturers are facing. But it’s important for device manufacturers to remember that regulations are shifting elsewhere in the world as well, including in the Asia-Pacific (APAC) region. In this post, we explore the regulations in four APAC countries.
1. Australia
In 2016, Australia made a commitment to aligning its medical device regulations with the EU “wherever possible and appropriate.” To that end, Australia’s Therapeutic Goods Administration (TGA) announced plans in April 2019 to enhance oversight of new devices, increase post-market monitoring, and provide greater transparency to patients. The TGA is also planning to upgrade its reporting systems to allow consumers to submit adverse events via smartphone apps.[1]
2. China
In China, the National Medical Products Administration (NMPA), formerly the China Food and Drug Administration, is responsible for regulating medical devices and improving the quality of imported products. China overhauled its medical device regulations in 2014, introducing a new device classification system based on level of risk to the human body. Low risk (Class I) devices only require filing, but moderate (Class II) and high (Class III) risk devices require clinical trial data unless the manufacturer receives an exemption.
In 2018, the UNMPA published a draft amendment to its medical device regulations which included a proposed provision allowing manufacturers to submit foreign clinical study data in lieu of China study data. This draft amendment also proposed a provision requiring all medical devices to have a unique device identification, similar to the EU MDR.[2]
3. India
In India, medical devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare. Medical device regulation in India is relatively new, as no regulations existed prior to 2005. In 2017, the CDSCO published its Medical Device Rules based on the principles of the Global Harmonization Task Force (GHTF). These regulations took effect in January 2018 and require manufacturers who are interested in registering their devices in India to provide proof of approval in their home market.[3]
4. Japan
In Japan, medical devices are regulated by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labour, and Welfare. In 2014, Japanese medical device regulation shifted due to the passage of the Pharmaceutical and Medical Device Act, which instituted changes in registration requirements, quality management system compliance, and third-party certifications.
Device risk classifications in Japan are based on GHTF determinations, but the regulation is classified into three categories: general medical devices (Class I), controlled medical devices (Class II), and specially controlled medical devices (Class III). For Class I devices, manufacturers only need to submit notification for regulatory affairs. For Class II and III devices, manufacturers must submit applications to Registered Certification Bodies or the PMDA.
Of note, manufacturers who produce their devices outside of Japan must obtain Foreign Manufacturer Registration (FMR) in order to market those devices in Japan. This registration process is distinct from product registration and, once registered, an FMR certificate is valid for five years.
Key takeaway
As medical devices become increasingly prolific, there is a near-universal demand for safe, high-quality products and a global push towards harmonization of device regulations. However, to date, medical device regulations vary across the APAC region, and manufacturers must carefully consider their APAC regulatory strategies early on in the product development cycle. As the regulatory environment continues to evolve, it is critical for manufacturers to stay abreast of changes so they can plan accordingly. To learn more, download our white paper Best Practices for Interventional Cardiovascular Medical Devices Trials in Asia.
[1] Baker McKenzie. TGA Announces New Action Plan for the Regulation of Medical Devices. Baker McKenzie website. Published April 8, 2019.
[2] RegDesk. An Overview of Medical Device Regulations in China. RegDesk website. Published January 9, 2019. https://www.regdesk.co/an-overview-of-medical-device-regulations-in-china/.
[3] MedCert. India: New Medical Device Regulations. MedCert website. https://www.medcert.de/en/india-new-medical-device-regulations/.