CHINA’S MINISTRY OF HEALTH AND THE STATE DRUG ADMINSTRATION: AN OVERVIEW
China's $22.5 billion pharmaceutical market is the second largest in Asia, after Japan, and foreign drug imports and pharmaceutical investment in China will likely increase as China enters the WTO. Anticipating an influx of foreign pharmaceuticals, the Chinese government established the State Drug Administration (SDA) in March 1998, an organization created to oversee drug importation through law and inspection.
The SDA consolidates the former State Pharmaceutical Administration of China (SPAC), the Bureau of Drug Policy Administration (BDPA) and the State Administration of Traditional Chinese Medicine (SATCM). The organization’s goals are to streamline the enforcement and inspection processes, as well as to "clean up" China's domestic medicine market to increase its competitiveness for China’s WTO accession. The SDA has authored several revised regulations since its conception, including the "Provisions for Import Drug Approval."

China’s Ministry of Health (MOH) is the agency responsible for public health and welfare issues in China. Under the leadership of Minister Zhang Wenkang, the MOH is responsible for: drafting laws, regulations, plans and policies with regard to public health; implementing disease prevention and treatment programs; directly overseeing 34 State hospitals; reforming medical institutions; supervising blood collection; setting quality standards; training health experts; and the like.

MOH plans and programs had significant success in the early years. Life expectancy increased from 35 years in 1949 to 70 by the 1990s, and significant gains were made in infant mortality and immunization. However, China’s health care system has begun to show signs of strain. Between 1978 and 1987, government spending on medical care increased 28 fold and became unsustainable. The increase was due to a variety of factors, including longer life spans (diseases of older people are difficult and expensive to treat) and an increase in unhealthy lifestyles. To deal with rising costs, the MOH has cut drug prices, separated hospital pharmacies from hospitals, and instituted other reforms. Additionally, the MOH has announced that within the next two years, medical service organizations will be divided into for-profit and nonprofit units, presumably increasing competition and therefore lowering costs.

IMPORTING NON-APPROVED MEDICAL DEVICES INTO JAPAN: A GUIDE
The importation of medical devices that have not yet been approved by the Japanese government falls into two broad categories, based on the purpose of the importation. The first category is for products being imported for personal use by individuals, while the second category covers almost all other products. This second category is divided into two further groups, differentiated according to the nature of the importation. The first group in this category is entities importing the devices for non-clinical evaluation and testing purposes. The second group is entities importing the devices for clinical evaluation and clinical testing purposes. This second group is then further divided into two sections according to the nature of the entity. Basically, it is divided between 1) physicians importing the devices for personal use or for clinical or non-clinical testing purposes, and 2) entities importing the devices for use in clinical trials to be conducted in Japan.

While the above breakdown may appear complicated, it can be simplified by categorizing into three groups as follows:
1) Individuals: for personal use only;
2) Commercial/non-commercial entities: for non-clinical testing, for clinical testing; and
3) Physicians: for personal use, for clinical testing, and for non-clinical testing.

In order to import medical devices for use in pre-clinical feasibility studies, the following documents need to be submitted to the regional health regulatory authorities in Japanese:

1) YUNYU HOKOKU SHO (Importation Notification Document) - 2 copies
2) NENSHO (Statement of Compliance) - 1 copy
3) SHIKEN KENKYU KEIKAKU SHO (Testing and Research Plan) - 1 copy
4) SHIIRE SHO (Invoice) - 1 copy
5) Air Way Bill (AWB) if by air freight or Bill of Laden (B/L) if by ocean freight - 1 copy
6) SHOHIN SETSUMEI SHO (Product Explanation) - 1 copy

IMPORTING MEDICAL DEVICES TO THAILAND: THE BASICS
The Thai market for healthcare products grew an estimated 12 percent last year. The next few years should see similar or even greater growth. With heart disease and cancer the two major causes of death in Thailand, and increasing numbers of Thais reporting respiratory ailments (caused largely by Thailand’s rampant air pollution), products in these areas potentially have high sales in Thailand. Such products include, but are not limited to, heart valves, stents, and artificial blood vessels; respiratory devices; oxygen generators; and guidewires.

The Medical Devices Control Division of Thailand’s Ministry of Public Health controls the import of medical devices. The government classifies medical devices as follows: Class 1 devices, which include condoms, surgical gloves, and syringes, need a license from the Thai FDA to be manufactured, imported, and marketed in Thailand. Class 2 devices, which include rehabilitation devices, blood alcohol level measuring kits, and silicone implants, do not require a license, but do need to be registered. Finally, Class 3 devices, which include most medical products, must only be freely marketed and sold in the manufacturing country to be approved for import. A “Certificate of Free Sale,” issued by the U.S. FDA, a local Chamber of Commerce, or similar organization is also required to register Class 2 and 3 products before importing. Thailand will not accept any devices that are not approved in the country of origin.

VIETNAMESE PHARMACEUTICAL INDUSTRY: GOVERNMENT TO INVEST $1.5 BILLION
The Vietnamese government has announced it will invest up to $1.5 billion in the pharmaceutical manufacturing sector over the next 10 years. The money will be used for a variety of programs, including upgrading technology to meet Good Manufacturing Practice standards, developing and expanding the pharmaceutical supply network to poor and remote areas, and meeting a greater percentage of domestic pharmaceutical demand. By 2005, Vietnam would like to see domestic manufacturers producing 50 percent of domestically consumed pharmaceuticals.