Historically, Myanmar (known as Burma until 1989) has been isolated from the rest of the world. Recent political changes have, however, opened Myanmar up to the West, stimulating economic growth. In particular, the medical device markets are expected to experience high growth over the foreseeable future.

Myanmar was long shunned by the U.S. and European governments, through multiple sanctions placed by these Western governments. In the late 1990s, the United States placed economic and military sanctions on Myanmar. At the same time, the United States called back its ambassador due to severe human rights conflicts and oppressive military rule in the country. In 2011, Myanmar swore Thein Sein in after holding its first election in 20 years. Shortly thereafter, both the United States and European Union began loosening economic sanctions. In 2016, Daw Aung San Suu Kyi’s won Myanmar’s presidential election, ending 50 years of military domination. Although the Constitution bans her from becoming president, Aung San Suu Kyi’s official position as State Counsellor still provides her with a significant amount of power. In September 2016, President Obama pledged to lift even more sanctions placed against Myanmar in efforts to improve trade and business.

Due to their historic exile from the West, Myanmar’s healthcare system has been severely lacking. Currently, only basic care and minor acute disease management is offered from the government-supported public healthcare system. The World Health Organization ranked Myanmar’s healthcare system very low due to the government’s low spending on healthcare (approximately 3.5% of the government’s budget). Despite this, Myanmar’s opening to the West has generated much interest and support in recent years for improved healthcare.

Results from a recent survey conducted by Forbes showed that not only were Burmese consumers more interested in Western healthcare products, but they were also willing to pay more due to the belief that Western therapeutics are of higher quality than local products. While Myanmar must further address certain political issues and stimulate further economic growth, the medtech industry looks very promising for Western manufacturers and investors.

Government Healthcare Reform in Myanmar

Over the past five years, the Burmese government has worked to significantly increase healthcare expenditure, hoping to increase the healthcare budget 6% by 2020. The government is increasing focus on medical equipment and medicines, and building health insurance infrastructure. The government also plans on establishing a universal health coverage plan by 2030. This increased healthcare spending will make the Myanmar medtech industry a key opportunity for Western device companies.

Medical Device Registration in Myanmar

The Myanmar Ministry of Health’s Food and Development Administration (FDA) oversees the safety and quality of medical devices and drugs. Although not formally a law, imported medical devices must obtain an Import Recommendation (IR) from the FDA, which is often difficult due to complicated document requirements and long processing times. Most devices only need approval and not registration, with the exception of devices such as MRI machines, CT scanners and X-ray machines.

Currently, the only legislation that regulates medically related goods is the National Drug Law, enacted in 1922. The FDA is drafting the Law on Medical Devices so that it adheres to the ASEAN Medical Device Directive (AMDD). This law is a major technical regulation update for Myanmar, and will be followed by drafting implementation regulations and the development of a Medical Device Registration list.

Rising Demand for Medical Devices

A variety of factors have contributed to the increased need for medical devices in Myanmar. The increase in healthcare spending has driven the growth of healthcare facilities and the need to purchase new medical devices. Along with an increasing aging population, there is also a rising incidence of chronic diseases such as diabetes, cancer and cardiovascular disease. In general, innovative medical devices, minimally invasive treatments, telemedicine and mobile healthcare are rapidly gaining popularity in Myanmar.