Malaysia Gets More Proactive About Medical Devices

When you think international medical device markets, Malaysia usually isn’t the first on most peoples’ lists. However, the current Malaysian medical device market is valued at about $800 million, and it is growing. The market in Malaysia largely is driven by Western medical device imports, especially for more sophisticated high-end products. Between 2005 and 2010, medical device imports increased at 10 percent annually.

Malaysia has had steady economic growth since 2002. The economy recorded gross domestic product growth of about 5.1 percent in 2011. In April 2011, the prime minister announced “Invest Malaysia 2011,” a plan to attract foreign investment. Foreign direct investment increased by more than 400 percent to $7 billion in 2011. As Malaysia becomes wealthier, with increased healthcare demands, the country will import more sophisticated medical technology from Western companies in the next five to 10 years.

Mandatory Registration of Medical Devices
The Medical Device Act 2012 was passed in February by Malaysia’s Ministry of Health, requiring all medical devices imported and/or locally manufactured in Malaysia to be registered with the ministry.

Before this act, Malaysia’s Ministry of Health encouraged medical device establishments to voluntarily register their medical devices through an electronic registration system called MeDVER. This voluntary registration scheme was meant as a transitory step before medical device regulations were fully imposed. However, being registered under MeDVER did not mean that the Ministry of Health had
necessarily approved the product.

Now, the Medical Device Act 2012 will require all medical devices imported, exported, or sold in Malaysia to be registered with and approved by the Ministry of Health. Medical device companies will have a two-year transition period to familiarize themselves with the product registration process and make necessary preparations to get their products approved. Thus, the act will become fully enforced by 2014. Approved medical devices will be classified according to the product’s risk levels and intended use. The least risky products will be classified as Class A, and the most risky products will be classified as Class D.

Mandatory Registration of Establishments
The Medical Device Act 2012 requires all medical device establishments to register and obtain permits and licenses from Malaysia’s Ministry of Health. Establishments include: manufacturers, importers, exporters, distributors, local authorized representatives, and conformity assessment bodies of medical device products.

Registered medical device establishments will be required to have good design and manufacturing standards, conform to safety and quality assessment standards, and have proper procedures in the event of voluntary/mandatory recall.

Creation of Medical Device Authority
A separate regulatory move, The Medical Device Authority Act, also was passed by Malaysia’s Ministry of Health in February. The act creates a regulatory body called the Medical Device Authority that will oversee the new mandatory registration of medical devices and related establishments. Previously, the Medical Devices Bureau—a division within the Ministry of Health—was responsible for overseeing the voluntary regulation and development of Malaysia’s medical device industry.

The newly formed authority will be charged with the responsibility to enforce the new regulations on medical devices stipulated in the Medical Device Act 2012. This regulatory body also will be solely responsible for promoting the further development of the medical device industry in Malaysia.

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These two acts—the Medical Device Act of 2012 and the Medical Device Authority Act—will have far-reaching effects on the Malaysian medical device market. The mandatory registration of medical devices, as well as a new regulatory body, will serve to improve the quality and compliance of medical devices. Additionally, the acts will grant legal protection for medical devices under patent law, thus encouraging foreign investment in Malaysia’s growing medical device market.

Ames Gross is president and founder of Pacific Bridge Medical, a Bethesda, Md.-based consulting firm that helps medical companies doing business in the Asian market (www.pacificbridgemedical.com). A recognized national and international leader in the Asian medical markets, he founded Pacific Bridge Medical in 1988, which has helped hundreds of medical companies with business development and regulatory issues in Asia.

In Other Asia News … Singapore Speeds Device Approval The Health Sciences Authority (HSA), the regulatory body in charge of medical devices in Singapore, announced a dramatic change in its approval process of devices entering the country. In response to complaints from doctors and patients about the high costs and long waiting periods for approval, the HSA initiated a proposal for cutting approval times and registration costs of two low-risk medical device categories, Classes A and B. The proposed changes took effect on May 1. At the start of this year, new rules took effect requiring all medical devices entering the country to be registered with the HSA. Devices were categorized into risk classes A, B, C and D, with D being the highest risk. According to the HSA, Class A and B devices account for about 70 percent of all medical device applications it receives, so the new procedures should help a majority of those waiting for devices. The HSA now will exempt non-sterile Class A devices from registration. Only 20 percent of Class A devices qualify as sterile. There also will be no registration fee for any Class A device. Class B devices will fall into one of two categories: Immediate registration or expedited registration, depending on if the device has been registered with the HSA’s independent regulatory reference agencies. If the device qualifies for expedited registration, the approval time will be reduced from 100 to 60 days. Class B registration fees will be reduced from $1,845 (U.S.) to $1,123. Class A devices include products such as surgical face masks and wheelchairs, while Class D includes products that come into contact with vital organs, such as heart valves and neural stents. Thermo Fisher Opens Facilityin South Korea Waltham, Mass.-based laboratory equipment manufacturer Thermo Fisher Scientific has opened a demonstration and training lab in the South Korean capital of Seoul. The new lab joins two existing facilities that houseapproximately 100 employees. The 1,800-square-foot facility will give customers hands-on access to various Thermo Fisher equipment. “Expansion in emerging markets is a key component of our company growth strategy, and this new demonstration center is an important milestone in our plan to establish a more direct presence in South Korea, which is a large and growing market for us,” said Marc N. Casper, president and CEO. The demonstration center is not the company’s first, however. “First we build the commercial infrastructure, followed by a demonstration center (to bring in customers so that they can see first hand how our products work), then a manufacturing center and R&D center,” said Thermo Fisher spokesman Ronald O’Brien, referring to the company’s successes with this strategy in China, Brazil and India. Pushing for innovation and cost reduction, the company not only is focusing on expansion but containment as well—at least in the United States. Thermo Fisher is closing both of its manufacturing plants in Two Rivers, Wis., (that process will be complete in August). The company also is eliminating 43 of 100 jobs in the Milwaukee, Wis., plant where product development and lab equipment production takes place. Some of the production will go to Mexico. The company’s Madison, Wis., facilities remain untouched thus far. Lakeshore Technical College located in Cleveland, Wis., is offering free computer classes at the local Two Rivers High School to recently or soon-to-be laid offemployees of the closing plants. In a separate press release regarding new products, Casper stressed that the company is facing economic hurdles common to most companies in the industry: “While economic pressures are forcing our customers to be more productive, the need to address complex healthcare, environmental and industrial challenges is equally pressing.” —MPO Staff