The Filipino medical device market is worth more than $300 million, and it is set to grow at 9 percent over the next few years. Growth will be driven by increasing healthcare expenditures, medical tourism and a growing private sector. Demand will be met primarily by imports.
Medical device spending per capita was about $5 in 2011, close to per capita expenditures in Vietnam and China. The largest buyers of medical devices are private hospitals. While the country has some capacity to produce domestic products, almost all of the sophisticated medical equipment in the Philippines is imported. Local production constitutes less than 3 percent of the medical device market.
Domestically made products include sterilizers, incubators, suction machines and some disposables such as syringes and surgical gloves. Over half of the disposable medical products are imported. The Filipino government imposes a 3 percent tariff duty and a 10 percent value-added tax (VAT) on imported medical devices.
The Philippines has the second largest population in the Southeast Asia region. However, of a population of about 95 million, approximately 40 percent still lives on around $4 a day. While the country has had a history of political instability, economic and political conditions in the Philippines are steadily improving and are expected to continue. In 2012, the GDP growth rate was 6.6 percent, up from 3.9 percent in 2011. In 2010, President Aquino announced his plans to expand and improve healthcare coverage by 2013. The government plans to expand the coverage of the Philippine Health Insurance Corp (PhilHealth) to all citizens, particularly targeting the poor.
MEDICAL DEVICE REGULATION
The main medical device governing body in the Philippines is the Bureau of Food and Drug Administration (BFAD), under the Department of Health (DOH). The BFAD was established to ensure the safety, efficacy, purity and quality of health products in the Philippines. The Food, Drug and Cosmetic Act provides the regulations to monitor food, drugs, medical devices, diagnostic reagents, cosmetics and household hazardous substances in the Philippines.
In the Philippines, all foreign medical devices must be registered through the same procedure, regardless of whether they have been registered in the past in other countries. Radiation-emitting equipment must undergo local testing and is regulated by the Bureau of Health Devices and Technology (BHDT) under the DOH. The BHDT will issue a pre-registration certification for radiation devices.
Initial product registration licenses are valid for one year. The dossier requirements for product registration include the following:
- A Free Sale Certificate from the country of origin authenticated by the Philippines Consulate
- The physical description and specification of the finished product
- The list and quantity of all raw materials
- The product indications and directions for use
- Labeling materials
- The description of the manufacturing and packaging processes
- A product sample
- A receipt showing payment of the license application fee, etc.
Licenses are valid for five years. The renewal application requires the following documents:
- A copy of the most recent Certificate of Product Registration
- The product indications and directions for use,
- The list and quantity of all raw materials,
- The description of the manufacturing and packing processes,
- The description of the sterilization procedures, when applicable,
- The quality control procedure, for the finished product, etc.
PROSPECTS FOR GROWTH
Industry sources indicate that the most popular medical devices in the Philippines are those that diagnose and treat common ailments like heart and lung disease, stroke and kidney failure. These devices face the highest current demand and include electrocardiographs, electroencephalographs and electromyographs, ultrasonic scanning apparatus, UV or infrared ray apparatus, parts and accessories, dialysis instruments and apparatus and pacemakers.
There are also good opportunities for used or refurbished medical equipment in the Filipino medical device market.