MEDICAL DEVICES IN CHINA: REGULATORY OVERVIEW
Medical devices were not required to be formally registered for sale in China until late 1994. Since then, however, several regulations with regard to the import and sale of medical devices have been implemented. The State Drug Administration (SDA) is the central government agency which controls imported medical device (and pharmaceutical) registration and monitoring. Its scope and function is very similar to that of the Food & Drug Administration (FDA) in the United States. The SDA is responsible for ensuring the quality, safety, and efficacy of all imported medical products. All imported medical devices must be registered with the SDA.

In April 2000, a new, more comprehensive and stringent regulatory system for medical devices was introduced. Under the new regime, registration of a new product should (in theory) be completed within 90 business days, though this is still not happening in practice. In addition, the official cost of registration is under US$500, excluding the cost of testing and clinical trials. Real costs can be much higher, especially when the costs of entertainment and “good will” (i.e., Chinese banquets, etc.) are factored in. Registration of Class II and III products generally requires local type tests and clinical testing reports. The SDA can provide lists of certified testing laboratories. All registration documents must be submitted in Chinese, and original or notarized copies are required.

In addition to the SDA, other Chinese government agencies also have jurisdiction over the regulation of certain medical devices. The State Administration for Entry-Exit Inspection and Quarantine (SAIQ) issues safety licenses for imported “consumer products,” which include: medical diagnostic x-ray equipment; dialysis equipment; blood purification equipment; electrocardiographs; implantable pacemakers; and ultrasound equipment. Manufacturers of these products should be prepared to pay over US$10,000 per product to obtain SAIQ approval. The United States government hopes that through ongoing negotiations with regard to China’s WTO accession, the regulation of imported medical devices in China will be further streamlined and rationalized.

REGISTRATION IN HONG KONG: DEVICES AND PHARMACEUTICALS
Despite Hong Kong’s reversion to China in 1997, under the terms of its return, Hong Kong is exempt from the rules and regulations outlined above for Chinese medical devices. Hong Kong does require general registration of imported medical devices, but there are only a few basic requirements for their import. In general, imported medical devices must only demonstrate (through certifications, etc.) their adherence to internationally recognized (FDA) and/or British technical and quality standards.

Hong Kong also has special rules with regard to the registration of pharmaceuticals. Pharmaceuticals must be registered with the Pharmacy and Poisons Board, under the Hong Kong Department of Health, before they can be distributed, offered for sale, or sold. For those products manufactured in Hong Kong, the manufacturer is responsible for obtaining registration approval. In the case of imports, responsibility for registration falls on the importer, Hong Kong branch, subsidiary, or representative agent.

Application for registration of a pharmaceutical product is as follows. The application fee is about US$70 and should include: details of composition of the product; specifications of the finished product issued by the manufacturer; a certificate of analysis of a representative batch of the finish product, including the method of analysis; a certified copy of the manufacturer’s license and of the free sale certificate for the product, issued by its country of origin; product samples; one set of original or prototype labels, including container label and outer carton; copies of clinical papers and information on the manufacturing facilities in which the product is produced. In addition, for new chemical entities, additional information is required. Once an application is approved and the registration fee (about US$175 per product) is paid, a certificate of registration will be issued.

PHARMACEUTICALS IN INDIA: REGULATION AND PRICING
In India, the major sources for pharmaceutical regulation are the Drugs and Cosmetics Act of 1940 (DCA) and the Drugs and Cosmetics Rules (DCR). This legislation applies to the whole of India and all products, whether imported or made in India. The legislation is enforced by the Central Government (Department of Chemicals and Fertilizers, Ministry of Chemicals and Petrochemicals) in New Delhi, which is responsible for overall supervision. The office of the Drug Controller of India (DCI) has prime responsibility. However, at the field level, enforcement is done by individual local State governments, through their Food and Drug Administrations. Matters of product approval and standards, clinical trials, introduction of new drugs, and import licenses for new drugs are handled by the DCI. However, the approvals for setting up manufacturing facilities, and obtaining licenses to sell and stock drugs, are provided by the local State Governments. Price controls are in effect on certain drugs, by virtue of the Drug Prices Control Order 1995 (DPCO), under the Essential Commodities Act. Other relevant, but general legislation is administered by Government Ministries in charge of Civil Supplies, Law, Industry, etc.

Drug prices in India are among the lowest in the world (and imports, unless they are very new and unique, are therefore negligible). There are several reasons for this. First, only product patents and not process patents (for pharmaceuticals) are so far recognized under Indian law. Therefore, Indian manufacturers can make bulk drugs and formulations by “reverse engineering” medicines patented overseas, reducing R&D expenses and also avoiding royalty payments. Further, Indian labor costs are low compared to overseas levels. India also has a large pool of technical and managerial personnel and does not need management skills from overseas. Most of the plant and equipment is made locally. Most importantly, a measure of statutory price control for bulk drugs and formulations exists in India. Certain drugs are under price control, and the prices of these bulk drugs and formulations thereof (whether imported or locally manufactured) are prescribed by Government, under the Drug Price Control Order, 1995. The price control regime is administered by the National Pharmaceutical Pricing Authority (NPPA). Other products can be priced freely. The Government can exempt certain products from price control if they are new drugs discovered in India or bulk drugs produced from the basic stage by a new process discovered in India or drugs manufactured by small-scale industries (capital investment below a certain level). The Government proposes to reduce the number of products under price control in the near future.

MALAYSIAN REGULATORY REQUIREMENTS: MEDICAL DEVICES
Though the government has indicated in the past that it plans to establish a medical device certification system, at present there are no requirements for registration of medical devices in Malaysia. Malaysia does require that FDA, CE mark, or other international approval documentation accompany those products that are considered “experimental” in their country of origin when they are imported. The only other exception is for x-ray and other radiation emitting equipment. The import of such equipment requires a permit from the Ministry of Science, Technology, & Environment’s Atomic Energy Licensing Board.