Malaysia might not be the first country that comes to mind when medical device manufacturers want to export their products to Asia. However, the nation of 28.8 million has a medical device market of more than $1 billion, which is expected to grow 15.9 percent per year through 2017.
Malaysia’s market is driven largely by imports, especially for high-end products. Lately, the government has encouraged domestic manufacturers to move away from low-end products like surgical gloves, and into advanced products like diagnostic imaging equipment.
The Malaysian economy continues to grow. Gross domestic product went up by more than 5 percent in 2011, according to the World Bank. As the country’s wealth increases, Malaysian citizens will demand more and better medical devices. Demand will likely be met by imports over the next five to ten years.
MEDICAL DEVICE REGISTRATION REQUIREMENTS
In February 2012, Malaysia’s Ministry of Health (MOH) passed the first comprehensive legislation that required the registration of all medical devices — the Medical Device Act 2012.
Prior to this, the MOH urged medical device establishments to register their devices through an entirely voluntary system, an electronic portal called MeDVER. The portal was meant to transition applicants to the mandatory registration process. However, devices listed on MeDVER are not guaranteed to obtain approval under the new system, since the MOH was never required to evaluate them.
Starting in July 2013, all medical devices that are imported to Malaysia will have to be registered with and approved by the MOH. Medical device companies have two years to familiarize themselves with the process and transition to the new system. Those who fail to register by November 2014 will face significant fines and possibly jail time.
Approved medical devices shall be classified according to risk level and the products’ intended usage. Those products posing the least amount of risk will be considered Class A medical devices, while those products posing the most risk will be considered Class D medical devices.
ESTABLISHMENT REGISTRATION REQUIREMENTS
In addition to device registration, the Medical Device Act 2012 calls for all medical device establishments (manufacturers, distributors, importers, exporters, conformity assessment bodies and local authorized representatives) to obtain licenses from the MOH. Registered medical device establishments must have proper procedures for recalls and good manufacturing and design standards. They must also conform to quality and safety assessment standards.
Unlike the device registration transition time of two years, local manufacturers, importers and distributors will have just one year to obtain their establishment licenses.
A NEW MEDICAL DEVICE AUTHORITY
In a separate piece of legislation, the MOH also created a new body to oversee all medical device and establishment registration. The Medical Device Authority Act — passed in February 2012 — mandated that the new Medical Device Authority would be solely responsible for enforcing the new regulations and promoting Malaysia’s medical device industry.
In the past, the MOH Medical Devices Bureau was in charge of the voluntary regulation system and industry development.
The Medical Device Authority Act and the Medical Device Act 2012 will both have significant effects on Malaysia’s medical device market. Mandatory registration will improve the quality and the compliance of medical devices on the market. The acts will also serve to protect medical devices under patent law, encouraging further foreign investment in the country’s growing medical device market.