A Rundown of Recent Regulatory Updates in Asia

Home to 4.5 billion people and the world’s second- and third-largest economies (China and Japan), Asia certainly has experienced economic success. In order to be successful in Asia’s medical device markets, however, it takes more than just financial savvy. It takes solid intelligence about regulatory news in the region.


Here are some country-specific updates.


South Korea
With a market size of $3.6 billion, South Korea has the third-largest medical device market in Asia, after Japan and China. Thanks in large part to a population of more than 48 million people, South Korea’s medical device market is expected to grow by about 5-7 percent during the next five years.

The Korean Food and Drug Administration (KFDA) decided in April that it would overhaul its Medical Device Act. The expectation is that once the regulations are revamped, the registration and approval of medical devices will become more transparent and predictable. The revisions also include detailed requirements for Class II to Class IV medical devices. Revisions include:

The length and complexity of the approval procedures of pre-market medical devices in Korea have changed. The time to register devices with a low risk level has been shortened, and their requirements have been simplified. Third-party bodies now are responsible for reviewing some Class II devices, many of which are well-known or “me-too” devices.

Technical review of Class III and IV devices is mandatory. Devices with substantial equivalency (SE) to other products that already have been approved in Korea have different requirements than non-SE
devices. SE devices do not require their own clinical reports. Non-SE devices, however, require their own clinical reports. If foreign clinical reports are deemed sufficient by the KFDA, no local clinical studies will be required in Korea.

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A new certification system is in effect for foreign medical device manufacturers. If a foreign device has been approved by the KFDA before April 8, 2012, the KFDA will grant a KGMP certificate to the foreign manufacturer without additional requirements. The Korea Good Manufacturing Practice (KGMP) certificate first will be given to the importing company, which then will transfer the certificate to the foreign manufacturer. However, if there is a new product, or if an existing foreign manufacturer has a new manufacturing site, an on-site inspection or a document review will be required for the manufacturer to get KGMP-certified.

In the past, many foreign device companies had to duplicate tests in Korea for product registration. But foreign test reports and manufacturer studies that are conducted by good laboratory practice labs and comply with international standards (e.g., ISO 10993, ASTM International, U.S. Pharmacopeial Convention standards, etc.) now will more easily be accepted by the KFDA.

In-vitro diagnostics will be regulated as medical devices starting Jan. 1, 2013.

Taiwan
Despite its small size compared with larger East Asian countries such as China and Japan, Taiwan has one of the most developed medical device markets in Asia, boasting a market size of $1.6 billion. With a population of more than 23 million people, Taiwan’s potential for growth in the medical device market cannot be ignored.

The Taiwan Food and Drug Administration (TFDA) decided in May that it would adopt the Summary Technical Documentation (STED) system for registering medical devices. This will bring Taiwan’s medical device registration system on par with the standard outlined by the Global Harmonization Task Force (GHTF) in “GHTF SG1-N11: 2008—Summary of Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices.” In an attempt to facilitate communication between regulatory agencies in different countries, the GHTF has been promoting the use of STED among medical device manufacturers and government regulatory agencies.

The implementation of STED in Taiwan will be phased in over the next year. From July through December this year, the Experimental Stage 1 (voluntary) for Class III medical devices will begin. Experimental Stage 2 (voluntary) for both Class II and Class III medical devices will take place January to June 2013; then, starting in July 2013, Implementation Stage 3 (mandatory) will be in effect for both Class II and III medical devices.

To ensure a smooth transition into STED, the TFDA encourages foreign medical device companies to submit a description of each product that includes its specifications, such as components and accessories. An essential principles checklist is available for foreign companies’ reference. Items on the checklist include design and manufacturing process, product verification and validation, risk analysis and control summary, as well as complete test reports for every STED (for Class III medical devices only).

Malaysia
Though it may be among the smaller Southeast Asian countries, Malaysia has a developed medical device markets, with a market size of $900 million. This compares to $430 million of the market in Indonesia, whose population is more than eight times bigger than Malaysia’s. With more than 28 million people and a burgeoning middle class, Malaysia’s medical device market is expected to grow 10-12 percent in the next five years.

Medical devices used to be unregulated in Malaysia but this situation is about to change. The Ministry of Health (MOH) of Malaysia decided in March to tighten control over medical devices. All medical devices now will require registration, and a new government agency will be created to regulate medical devices.

Currently, medical devices are registered on a voluntary basis in Malaysia, under the MeDVER system. During the next two years, however, all imported and locally made medical devices must be registered under the Medical Device Act 2012 (Act 737). Approval will be required from the Medical Device Control Division (MDCD), a subsidiary agency within the MOH that is responsible for monitoring the distribution of medical devices. A classification system (Class A through Class D) will be introduced for medical devices to evaluate the risk of the device. Medical devices now will be defined by the MOH as any instrument used to diagnose, prevent, monitor and/or treat disease and injury.

All parties and facilities involved in the medical device industry, including distributors, importing companies, quality assessment bodies and manufacturers, will be required to be registered and approved by the MOH. Under the Medical Device Authority Act 2012 (Act 738), a medical device authority will be created to oversee the regulations of medical products as mandated in the Medical Device Act. It also will promote the medical device market in the country.

These two acts undoubtedly will have a tremendous impact on the medical device industry in Malaysia. Quality of medical products will improve, and patents for registered medical devices will enjoy greater protection from the authorities than ever before.

Singapore
Despite its small size and population (4.7 million people) compared to most other Asian countries, Singapore also has a highly developed medical device sector, boasting a market size of $500 million.
Medical devices are classified into four classes in Singapore, based on how they are intended to be used and the risks that may arise from their use. The Health Sciences Authority (HSA) of Singapore decided to lower regulatory requirements for Class A and Class B medical devices, which have lower risks and account for almost 70 percent of medical device use in the tiny city-state. The new requirements will speed up the market entry process of these lower-risk medical devices.

At present, it is mandatory that devices with the lowest risks—Class A—be registered before entering Singapore. However, beginning in May this year, only sterilized Class A devices must be registered before they are marketed. The time needed to process the approval will be shortened to 30 working days. For unsterilized Class A devices, the $25 registration fee no longer is required. Nevertheless, in order to allow for post-market surveillance and monitoring, importing companies and manufacturers still are required to declare all Class A medical devices in their licenses.

Starting in September, the registration procedures for Class B medical devices also will be accelerated. If a device has been on the market for at least three years without any safety issues and has been approved by at least two major international regulatory bodies (for example the U.S. Food and Drug Administration; Japan’s Ministry of Health, Labor and Welfare; European Union Notified Bodies, Health Canada and Australia’s Therapeutic Goods Administration), it will receive immediate approval from the HSA.

If a device has been approved by two of the aforementioned agencies but has not been marketed in Singapore without safety concerns for at least three years, its registration time will be shortened to 60 days. The same expedition will be given to devices that have been approved by only one of the aforementioned agencies but have been marketed in Singapore for at least three years without any safety issues. For both immediate and expedited approvals, the registration fee will be lowered from $2,300 to $1,400.

The HAS also introduced a simplified classification system with fewer tiers for small, low-cost medical devices that are approved by the GN-27 Special Authorization Route. Starting this August, the HAS also will lower application fees and lengthen the timeframe for which the approval is valid from two months to one year.

Ames Gross is president and founder of Pacific Bridge Medical, a Bethesda, Md.-based consulting firm that helps medical companies doing business in the Asia market. 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. For more information, visit www.pacificbridgemedical.com.