Asian Medical Device Markets - Emerging Regulations
The growing importance of medical device regulations in the healthcare industry in Asia is reflected in the recent regulatory moves initiated by the governments of a few countries in the region.
Rajeshwer Chigullapalli and Akhil Tandulwadikar
The healthcare regulations arena in Asia has witnessed a slew of action over the last few months. Governments and regulatory bodies of countries across the region have been busy putting in place new regulatory systems or reforming the existing ones. While India and Malaysia finally seem to have woken up to the need for a regulator, China, the second biggest market in Asia after Japan, has been sprucing up its regulatory system and is setting the stage for unleashing further reforms. While all this certainly augurs well for the medical device manufacturers around the world who are trying to penetrate into these markets, the eventual beneficiaries will be the end users - the hospitals in the region. In an industry like healthcare the need for a regulatory agency that puts the interests of patients above everything else, any attempt to improve the regulatory system that governs medical equipment is of paramount importance as it ensures the safety of patients and facilitates sustainable development of the market.
Towards Better Markets
Medical equipment and device makers from all over the world have been focusing on the Asian markets for medical devices for a long time now. But in recent years factors such as major disease outbreaks, increasing health consciousness and lack of serious domestic competition have fueled the rise of these markets . Many countries in the region rely heavily on imports to satisfy their needs. Last year the spending on healthcare in Asia grew at approximately 45%, according to Pacific Bridge Medical.
Consider the case of Malaysia, where 90% of the medical equipment is imported. Its medical device market is valued at around US$ 300 million. While Malaysia’s pharmaceutical industry has a regulator (Drug Control Authority or DCA ), all that existed for the medical device industry was a draft Medical Device Act. This situation changed only when the Malaysian government implemented the Voluntary Registration for Medical Devices Establishment (MeDVER) system in January 2006. Around 154 manufacturers, importers and distributors of medical devices have registered with MeDVER . Following this, the government has gone ahead and announced recently that a legislation is being drafted to ensure the safety and effectiveness of medical devices sold and used in Malaysia. It announced that a framework is being prepared to determine the method of regulating the use of medical devices based on recommendations by international advisory bodies like the Global Harmonisation Task Force. "Development of a regulating programme based on international standards and compatible with the system practiced by Malaysia's trading partners will reduce trade obstacles and enable Malaysian-made medical devices to compete and penetrate global markets," said Malaysia’s Health Minister Datuk Dr Chua Soi Lek. The ultimate beneficiary of these safety regulations however will be the end users of these devices, as they will have access to products that pass through the regulatory rigors.
Similar is the case with India. In spite
of
the
fact that the medical device market
is valued
at over US $ 1.5 billion and is heavily
dependent on imports (75%),there
is very
little to talk about a regulatory body for the medical device industry.
Therefore, the government’s recent
guidelines
for licensing of import and manufacture of medical devices have come as a welcome move. The government
notified that 10 medical devices including cardiac and
drug eluting stents as drugs that require central clearance prior to import, manufacture or marketing in the country. Reacting to the move, Milind Shah,
Managing Director Medtronic Inc’s India operations said that the notification will
allow market to grow and help patients access the best available to diagnosis, monitor and recover at a faster pace.
Going further, the government has also announced the setting up of National
Drug Authority. Apart from monitoring
drugs and clinical trials the new body will
also regulate and approve the safety of medical devices, just like its counterpart
in the US, the Food and Drug Administration (FDA).
While India and Malaysia have moved in to institute medical device regulations for the first time, other nations like Taiwan and China have made some crucial changes to their existing regulatory systems. Recent initiatives by the Department of Health (DOH), Taiwan have made the registration of medical devices a lot easier by helping reduce the time taken for registration. Previous regulations passed in mid 2005, had made it very difficult for manufacturers to register their products. The new regulations allow registration for Class 1 (low risk) devices to be completed in as little time as 15 minutes, as compared to the earlier 140 days. Taiwan has one of the most sophisticated markets for medical devices in the region and in spite of being a small nation its market is one of the biggest at US $ 900 million.
Comparatively, China’s healthcare regulator the State Food and Drug Administration (SFDA), has been actively reforming its device regulations over the last few years. This is reflected in the number of medical device licenses issued by the SFDA, which grew from 1104 in 2001 to 4029 in 2004. But there continue to be problems in registration for foreign manufacturers. “Local procurement policies, testing requirements, protection of intellectual property and restrictions on the types of business activities in which foreign firms can engage are all potential challenges for foreign medical device companies.” pointed a report by Pacific Bridge Medical last year. However, on May 24, 2006 SFDA issued the project plans to revise the industry standards for medical devices. When complete, the revised norms will most likely ease the process of registration of devices in the country, benefiting the manufacturers and users.
Finding the Balance
Medical device regulation can be a tricky issue, as regulators have to find the critical balance in being stringent with regards to quality control and safety of the devices and at the same time ensuring that the regulatory procedures consume as little time as possible, since this will directly impact the patients healthcare. Delaying the approval of critical equipment or approving devices that could cause harmful side effects to the patients are challenges that regulators face all the time. The regulators in the emerging Asian economies will face similar challenges in the coming years. How they face up to them will be a closely observed issue.
