Regulation of Cardiovascular Devices in Asia The regulations governing cardiovascular devices in

Regulation of Cardiovascular Devices in Asia

The regulations governing cardiovascular devices in Asia differ from country to country. There also are different risk classifications for different types of cardiovascular devices, depending on the risk levels posed to patients. China, for example, has three risk classes for medical devices—Class I (low risk) to Class III (high risk). Class III medical devices are those which are “implanted into the human body, or used for life support or sustenance.” Examples of Class III cardiovascular devices in China are implantable cardiac pacemakers and devices for cardiovascular endoscopy.

Although Hong Kong now officially is part of China, its medical device regulations are different from China. Cardiovascular devices need to be registered with Hong Kong’s Department of Health through the Medical Device Control Office before they can be sold in the Hong Kong market. Unlike China, Hong Kong has four different risk classes: Class I (lowest risk) to Class IV (highest risk). Implantable cardiac pacemakers are classified under Class IV. Cardiovascular stents also are classified under Class IV if these devices involve “direct contact with the heart or central circulatory system” of the patient.

On the other hand, developing countries such as India are just beginning to implement more comprehensive guidelines for medical devices. To date, India has not developed specific definitions for various medical devices. However, a new medical device regulation bill is expected to be in place in India soon. Currently, cardiovascular devices such as cardiac stents and heart valves as well as cardiac patches and occluders used in interventional cardiology procedures are considered drugs under the Drugs and Cosmetics Act of India.

Asia’s market for cardiovascular devices is growing quickly. Many Asian governments increasingly are adopting national healthcare programs targeted at improving cardiovascular health. Seeing this market potential, some international cardiovascular companies also have established local manufacturing facilities in Asia for cost effectiveness. There also are certain Asian governments that provide foreign companies with investment incentives and tax breaks in high-tech medical sectors.

A good example is Singapore, where the small city-state’s well-equipped infrastructure and skilled labor have encouraged foreign investments in high-end cardiology equipment manufacturing. Recently, Medtronic established a new manufacturing facility in Singapore for cardiac devices. Medtronic’s Singapore facility started operations in January and also serves as the Asia headquarters and regional distribution hub for its Cardiac Rhythm Diseases Management business. Elsewhere, medical device companies such as Sandvik AB of Sweden have established device manufacturing facilities in India to take advantage of low production costs. Some of the cardiovasculardevices manufactured by Sandvik in India include pacemaker lead wires.

For companies looking for international growth, understanding the various nuances of the Asian cardiovascular market can lead to a plethora of potentially lucrative sales and manufacturing opportunities.