A list of recently published and updated articles regarding medical device regulatory updates from the PFDA and other governing bodies in the Philippines.
The PCSO is a major source of funding for new hospital construction and medical device and equipment purchases and is often overlooked by outside suppliers. Medical device manufacturers should discuss with their Philippines distributors about what opportunities are available through the PCSO.
Asia Actual is excited to announce the dedication of our new office space in the Philippines. The investment reflects the company’s commitment to the Philippines market and expectations for growth.
New medical device regulations in the Phillipines have been launched. Class A, Class B, Class C, and Class D medical devices will all be affected.
US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.
The Philippines Department of Health published a draft schedule of fees to be charged for medical device registrations under the new Rules next year. As per Administrative Order 2018-0002, medical devices will be classified by increasing risk from A to D.
The Philippines Food and Drug Administration (FDA) intended to implement the first two phases of the new medical device regulatory system (known as Administrative Order 2018-0002) on April 11, 2019, however the implementation date has been delayed. Extra time is needed for the CDRRHR to finalized guidelines for classification and grouping, etc.
The 8th ASEAN Medical Device Committee Meeting (AMDN) will take place in Manila from August 4-8, 2019.
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