Medical devices in Malaysia to register with Health Ministry
Malaysia will soon introduce its Medical Devices Act by the end of 2011. This Act is expected to be established when the current Medical Devices Bill 2008 is presented to the Malaysian Parliament either at the end of March 2011 or in June 2011.
The new Medical Devices Act will require imported and local medical devices to be registered with the Health Ministry of Malaysia. This is to ensure quality products in medical treatments, as well as to legally protect the medical devices under the country’s patent law. Currently, registration of medical devices is not mandatory in Malaysia.
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Major medical devices manufactured in Malaysia include syringes, surgical equipment, blood transfusion
sets, blood pressure transducers, dialysis solutions, diagnostic radiographic equipment and orthopedic products. Apart from these, Malaysia is also a major exporter of catheters and surgical gloves.
The Malaysian medical device market is currently estimated at $600 million. The market is projected to increase to $700 million by the end of 2011. This will be aided by government investments in healthcare, increasing number of health insurance policy holders as well as greater private medical spending by middle-income Malaysians.
New quality control for Thailand’s medical devices
Thailand is raising its quality control standards on local manufacturing of medical devices. According to Thai government officials, a medical device institute may be set up as a testing center for quality standards. New quality standards are also expected to be outlined by the Thai government. This is to enhance Thai medical device manufacturers’ competitiveness in South East Asia, in terms of design, research and development and product quality. Key medical devices manufactured in Thailand are diagnostic and laboratory reagents, radiation treatment apparatus as well as oscilloscopes and spectrum analyzers.
There are currently about 1,700 medical device companies in Thailand. 80% of these companies are local. Nevertheless, Japanese medical device manufacturers are gradually penetrating the Thai market, targeting local public hospitals. In 2009, Thai public hospitals accounted for 60% of medical device purchases in the country.
Thailand’s medical device market in 2010 totaled about $700m. This was larger than neighboring countries such as Indonesia, at $400 million and Malaysia, at $600 million during the same year. The Thai government expects the country’s medical devices to grow to $1.2 billion by 2015. About two-thirds of Thailand’s medical devices are imported. These are mainly from the United States, which account for almost 30% of these total imports.
US-South Korean Free Trade Agreement enhances medical equipment competitiveness
The US-South Korean Free Trade Agreement (KORUS FTA) is expected to improve the competitiveness of US medical equipment and pharmaceuticals. Once approved by the US Congress, the KORUS FTA will enable more than 90% of US medical equipment exported to South Korea to obtain duty-free status. The duty-free status would be given within 3 years of the FTA implementation. Out of this 90%, more than 43% of the US medical equipment exports would receive duty-free treatment immediately upon the FTA implementation. This compares to the existing 5.4% medical equipment tariff in South Korea, which can go up to 50% for some US exporters of medical products.
Under the FTA, South Korea will also agree to allow for higher reimbursements for US pharmaceuticals and medical devices under its single-payer health insurance program. Previously, US manufacturers had voiced concerns over the discrimination against innovative pharmaceuticals in the form of low reimbursement amounts. These low amounts did not consider the costs of innovative drug development of foreign pharmaceutical companies. Under the FTA, South Korea will also publish proposed new laws, regulations and procedures regarding the pricing, reimbursement and regulation of pharmaceuticals and medical devices in South Korea. To increase transparency, these will be published in a publicly available document, where further comment from the public will be allowed.
South Korea’s medical equipment market is currently estimated at about $2.7 billion. Although much smaller than that of China, at $7.5 billion, South Korea’s medical device market is projected to grow about 10% each year. This will be aided by healthy economic growth and a gradually aging population in need of medical care. Between 2008 and 2010, US authorities estimate that $1 billion of medical equipment was exported from the US to South Korea.
China complying with WHO vaccine regulation standards
In March 2011, an assessment by the World Health Organization (WHO) revealed that China’s vaccine regulations are now complying with international standards. This implies that vaccine manufacturers in China can now submit applications to have their vaccines pre-qualified by WHO.
China is the 36th vaccine producing country in the world where its regulatory system has been assessed as “qualified” by the WHO. The timeline for WHO to pre-qualify vaccines from China ranges between 1 and 2 years. Currently, China has 36 vaccine producing plants that produce 49 kinds of vaccines against 27 diseases.
China had previously failed WHO’s vaccine regulatory system assessment in 1999, 2001 and 2005. Since then, the country had taken steps to enhance its vaccine regulation standards. The new Good Manufacturing Practice (GMP) code adopted by the SFDA with effect from March 1, 2011, contains stricter requirements for vaccine production to ensure production of quality vaccines.
In early 2011, the SFDA also issued the Notice for Further Strengthening the Supervision of Quality and Safety of Vaccines. This Notice outlined some important initiatives which affect the R&D, manufacturing and distribution of vaccines in China. These initiatives include forming an expert panel to review industry policies, quality standards and quality assurance systems of vaccine manufacturers. The SFDA also requires companies to have detailed records of the source, history and biological characteristics of microbial or pathogenic strains for vaccine development.
Price controls for cancer drugs in India
India’s Department of Pharmaceuticals is in the midst of establishing a mechanism to regulate the prices of cancer drugs. India had been mulling over the decision to control cancer drug prices over the last two years. Soaring cancer drug prices in India have crippled the affordability of this treatment among cancer patients in the country. In a study conducted by India’s National Pharmaceutical Pricing Authority (NPPA), the government found that prices ranged widely for similar cancer drugs sold in India.
There are an estimated 2 million cancer patients in India. The number of cancer patients in India grows an average of 1%, or 1 million people each year. This is just slightly lower than the number of new cancer patients in the US, at 1.5 million each year. Cancer is India’s fourth largest killer, behind cardiovascular, respiratory and childhood diarrhea diseases. The current Indian cancer drug market is estimated at $280 million. This amount is expected to exceed $400 million by 2014, as the Indian population grows amid unhealthy living and rising environmental pollution.
Price controls for cancer drugs in India will not be easy. Currently, the Indian government can fix prices of commonly used drugs, but not prices of imported medicines, including cancer drugs and other patented drugs. However, there is a policy that allows the government to intervene in drug prices out of public interest. Nevertheless, this provision is only applicable to drug prices which have increases exceeding 10% a year. It is less effective for controlling drug prices which are initially set at high prices since the products’ launch.
Ames Gross is president and founder of Pacific Bridge Medical, recognized nationally and internationally as a leader in the Asian medical markets. He founded PBM in 1988 and has helped hundreds of medical companies with business development and regulatory issues in Asia. Ames can be reached at email@example.com.