I. Philippines Economy
The Philippines, like Indonesia was hit hard by the crisis, but is apparently now on the road to economic recovery. In 1998, the Philippine economy deteriorated as a result of spillover from the Asian financial crisis and poor weather conditions. Growth fell to a negative 0.5% in 1998 from 5% in 1997. The Philippines government is raising its 1999 economic growth target to 3.7%, significantly above the IMF’s estimates of 1.5 – 3.5%. The country recorded impressive growth of approximately 3.8% in the second quarter of 1999. The government has promised to continue its economic reforms to help the Philippines match the pace of improving infrastructure, overhauling the tax system to bolster government revenues, and moving toward further deregulation and privatization of the economy.
II. Philippines Medical Device Market
The total market size of medical equipment in the Philippines was $51 billion in 1998, with imports accounting for about $46 million – approximately 90% of the market. The U.S. had the largest market share – about 35%. Since many Filipino doctors have studied in the U.S., they are familiar with U.S. products and strongly prefer them. Industry leaders are optimistically predicting an 8% growth in the medical device industry in 1999 due to the increased consumption of medical equipment and other medical products, offering excellent opportunities for U.S. suppliers. Continuous requirements for medical services, new technology, and equipment replacement should spur market growth.
III. Medical Device and Diagnostics Registration
The medical device registration in the Philippines is governed by the Bureau of Food and Drugs of the Department of Health and is regulated according to the Rules and Regulations on Registration and Labeling of In-vitro Diagnostics Reagents. Product registration is required for each product. Most recently, the registration for diagnostic reagents has been frozen, but HIV, hepatitis and pregnancy test kits still have to be registered. While instruments do not require registration, it is still recommended that the relevant documents are provided to the Department of Health.
The documents required for registration or renewal include the following: a letter of application, the Certificate to Foreign Government from the FDA in the U.S. (or equivalent body in a country outside of the U.S.), certificate of manufacturing, agency appointment agreement, certificate of brand name clearance, two copies of the product insert that shows the constituents of the equipment, two copies of the technical specifications or physical distribution of the product, stability studies of the product to justify the claimed shelf life, the product label, a sample kit, the analysis certificate and the payment receipt. In addition, for renewal, a copy of the most recent Certificate of Product Registration must be included. The lead-time for this registration process is 3 months and registrations must be renewed annually.