Medical Device Registration in the Philippines 2018-05-31T10:24:26+00:00

Market Opportunity in the Philippines

The medical industry in the Philippines is almost totally dependent on imports and continues to present good opportunities for international medical device firms.

Growth in the medical industry of the Philippines is seen primarily in private facilities in more affluent and urbanized areas where there is adequate funding to procure new and high-end medical devices. This includes private hospitals in Manila such as St. Luke’s and the Asian Hospital and Medical Center. Medical device expenditure in the Philippines was estimated to be approximately US$3 per capita in 2012, similar to Indonesia and India, and is likely to continue to increase at a steady pace.

Almost a quarter of imported medical devices in the Philippines are imported from the U.S. Business Monitor International (BMI), in their report “Health Industry Forecast”, revealed that the Philippines medical device market is expected to grow 9.7% in the medium term. This will be spearheaded by the growth of imports, health expenditure, private health sectors and medical tourism. They assume the Philippines medical device market will achieve a solid 8% growth per annum to 2019 with modernization projects for hospitals and other healthcare facilities being the key driver of growth.

philippines_map

By CAGR, the expected medical device market will grow to 8.3%, which would rise from an estimated USD288.9m in 2014 to USD430.3m in 2019. By individual product area, the CAGRs are expected to range from 17.1% for orthopedic and prosthetics to 2.4% for other medical devices in the 2014-2019 period. It is expected that import performance will continue to rise in 2016 based on the strong performance in 2015. Imports increased by 66.1% in Q315 and by 22.2% in the year ending September 2015, taking the running annual total to USD305.4m. Thus, the Philippines offer good opportunities for commerce.

Andaman Medical can support your medical device launch in the Philippines

A foreign investor looking to introduce and market their medical devices in the Philippines will need to secure a license to operate as an Importer/Distributor/Wholesaler from the Philippines Food and Drug Administration (FDA). Moreover, a foreign-owned company looking to engage in a domestic market enterprise is required to have a minimum capital of US$200,000 and must undergo a lengthy establishment process. In order to prepare for your company’s product market entry, Andaman Medical is able to serve as your local representative to assist you in obtaining the appropriate regulatory roadmap and to ensure compliance with the Philippines’ importation and distribution regulatory requirements.

Based in Manila, our team of consultants will provide you with all the necessary information on the registration process and will help you to negotiate the Philippine regulatory process. Acting under the authority of your company, we will personally conduct the product registration process and obtain the certification after approval. Moreover, your products will be distributed within the country under our responsibility as the license holder, while our network of sub-distributors will undertake all sales and marketing activities.

Services

At the pre-registration phase, as a licensed medical device importer, we’ll support your scientific advice requests, prepare and review product dossiers, and provide a regulatory submission strategy to comply with the Philippine FDA. Andaman Medical Philippines is a qualified regulatory partner for any foreign companies who wish to market their products in the country. As your local representative, we will help you to obtain a general understanding of the medical device regulatory process and support you in organizing your legal and technical documents to comply with regulatory requirements. We have local associates who are knowledgeable in engaging with legal authorities to ensure that your medical devices pass successfully through customs clearance and achieve regulatory approval. Andaman Medical will handle any procedural hurdles and authority interactions that arise in relation to product distribution across the Philippines.
Currently, the Philippine medical device regulatory system requires that medical device manufacturers apply for and obtain a Certificate of Product Registration (CPR) or a Certificate of Exemption (COE) through the Center for Device Regulations, Radiological Health and Research (CDRRHR), prior to importation and commerce. Only local businesses who hold a License to Operate (LTO) can register medical devices in the Philippines. Thus, any foreign medical device manufacturers who wish to enter the Philippine market may liaise with Andaman Medical as their in-country representative. Andaman Medical will act as the distributing license holder for their products and we will personally submit the registration documents, periodically monitor the evaluation process, and rapidly take action when there are additional documents or data required. Andaman Medical Philippines will also provide distribution assistance to help you commercialize your products within the country.