JAPAN: MEDICAL DEVICE DESIGN CONTROLS UNDER THE NEW PAL
Japan’s New Pharmaceutical Affairs Law (PAL) will include revisions to the Good Manufacturing Practice (GMP) regulations for medical devices. Under the New PAL beginning April 2005, all medical devices manufacturers will need to meet the new Japanese GMP regulations, based on ISO 13845:2003. Included in this regulation are new detailed requirements for device design procedures.

All Market Authorization Holders (MAH) are required to designate a Good Quality Practice (GQP) Controller; this Controller will be in charge of overseeing GMP and product design compliance. The GQP Controller will ensure that any changes in the design of a medical device do not negatively impact the safety and efficacy of the device.

A company’s product design team, comprised of employees from the manufacturing plant, regulatory department, sales department and design department, will each contribute input for the design. The team will be required to develop and document a step-by-step plan for developing and carrying out the design, establish a timetable, and determine SOPs for design revision procedures.

The design process will consist of two main processes: design verification and design validation. Design verification involves the comparison of the design input (information on intended use, regulatory and safety requirements, similar devices and risk management) with design output. Verification includes the examination of performance tests, in vitro and in vivo tests, labeling and packaging tests, and others. Design validation is conducted at the final stage of the design process and is used to confirm that the design of the device satisfies its intended use. Validation tests are usually conducted under actual or simulated conditions, such as a clinical trial.

CHINA TO IMPLEMENT ADDITIONAL GMP REGULATIONS: AN UPDATE
In 1998, China’s State Food and Drug Administration (SFDA) introduced Good Manufacturing Practice (GMP) certification in order to emphasize quality and safety of pharmaceutical production. However, the certification was optional and occurrences of medical accidents and legal issues continued to arise due to poor manufacturing practices. Following China’s entry into the World Trade Organization (WTO) in 2001, as well as from the added pressure of the international drug community, the SFDA implemented a new regulation requiring GMP certification for all pharmaceutical manufacturers in China in July 2004. At that time, approximately half of the 6,000 drug manufacturers in China had already received GMP certification; the other 3,000 manufacturers were granted a six month grace period to upgrade their technology in order to meet the new standards.

Following the July 2004 announcement, the SFDA issued another notice in October 2004, which revealed future GMP requirements for IVD reagents, medicinal gases and Chinese crude drugs. Manufacturers of IVD reagents (administered as drugs) will need to meet GMP standards by January 1, 2006. Beginning January 1, 2007, medicinal gas manufacturers will require GMP certification. Finally, producers of cut crude drugs for Chinese medicine will need to obtain GMP certification by January 1, 2008. GMP standards for Chinese crude drugs will involve how the manufacturer processes and contains the prepared slices of the drugs, including the cleaning, cutting and steaming processes. Any manufacturers who fail to meet GMP standards by their respective deadline will be forced by the SFDA to stop production.

SINGAPORE : UPDATED GOOD DISTRIBUTION PRACTICE GUIDELINES FOR PHARMACEUTICALS
Recently, the Health Sciences Authority (HSA) released new guidelines on Good Distribution Practices (GDP) for pharmaceutical materials and products in Singapore. The new guidance, effective January 1, 2005, includes new and updated information on the GDP documentation system, electronic records, EEFO (Earliest-Expiry-First-Out) and FIFO (First-In-First-Out), and the handling of active pharmaceutical ingredients (APIs) and intermediates. The HSA issued the new guidelines in order to better ensure the reliability and quality of pharmaceutical materials and products during the distribution process.

Under the updated guidelines, some of the changes and new requirements are as follows. First, companies will be required to establish procedures for developing, controlling, and maintaining documentation related to the distribution process. The company should keep these documents up-to-date and have them readily available upon request. Second, if records are also maintained by electronic data systems, a detailed description and explanation of the system should be created. Any changes made to the data should be electronically recorded and can be used as reference information in the case of an audit. Third, companies will be required to develop an EEFO/FIFO system to help avoid distributing products with approaching expiration dates. Finally, anyone who distributes, trades, or stores APIs or intermediates in Singapore will need to maintain documents for tracing these products. Documents that allow for traceability should include the name and address of the original manufacturer, purchase orders, batch numbers, transportation information and Certificates of Analysis.

HONG KONG : MEDICAL DEVICES INCLUDED IN 2 ND PHASE OF HK–MAINLAND TRADE AGREEMENTS
On January 1, 2005, the 2 nd phase of Mainland China and Hong Kong’s Closer Economic Partnership Arrangement (CEPA) was launched. CEPA was established to remove barriers to trade between Hong Kong and the Mainland and to promote investment and cooperation. Under the new phase, 11 medical products will receive tariff preference. Stethoscopes, endoscopes, blood transfusion apparatus and anaesthetic apparatus are examples of products that will become non-tariff goods. CEPA only applies to products manufactured in Hong Kong and exported directly to Mainland China.

To be eligible for preference under CEPA, manufacturers must be registered with the Hong Kong Trade and Industry Department (TID). If registered, a manufacturer may apply to the TID for a Certificate of Origin, which verifies that the products to be exported under CEPA have been produced in Hong Kong. This is referred to as a CO(CEPA). The approval process can be completed within 1.5 working days.

Each CO(CEPA) is valid for 120 days from the date of issue. A single CO(CEPA) can cover a maximum of five Mainland tariff codes and those tariffs must correspond to goods eligible for zero tariff. The CO(CEPA) is used to authenticate the Mainland importer’s claim for CEPA tariff preference. However, importers are still required to fulfill Mainland customs clearance and other requirements.

In order to promote CEPA to small and medium-sized Hong Kong enterprises, the TID offers four funding schemes. Hong Kong firms can utilize these schemes to finance the purchasing of equipment to produce CEPA-eligible goods, hold trade fairs and exhibitions to promote their business in Mainland China, and take courses about the opening-up of the Mainland market.