US: +1 512 898-9222
SG: +65 3138-4148
Registration of Software in the Philippines, including AI software, can stress our bureaucratic regulatory, Customs, and tax accounting systems in Asia including the Philippines. Our people love to work with these devices and be the first to overcome the challenges.
The new medical device regulations in the Philippines (ref. Administrative Order No. 2018-0002) specifically identifies software as being included in the definition of a medical device (ref. clause IV Definition of Terms, sec. 15 Medical Device). So, it must be determined if the intended use of the software falls with medical device standards. For example, software for wellness, lifestyle and fitness are not typically considered medical devices.
Medical Device — means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article:
If your software is a medical device, the next step in the regulatory process is to determine the risk classification. The Philippines employs a risk-based classification system for (medical device SEO?) software as with all medical devices. Guidance is as per the ASEAN Medical Devices Directive 2015, Annex 2, Section 2 (16 rules for classifying medical devices), and Annex 3, Section 2 (7 rules for classifying IVD medical devices).
Risk-based classification is new to the Philippines where previously medical devices listed in Circular 2025-004 required registration, and all others were exempted from pre-market approval. To assist applicants with applying the new risk assessment the FDA has published additional guidance (reg. Circular 2020-001) assigning specific risk categories to common medical devices. Additionally, all medical device registration applications include a pre-assessment at which classification and grouping on confirmed.
New regulations implemented on April 1, 2019, require Class A, B, C and D medical devices to attain a Certificate of Medical Device Notification (CMDN), or Certificate of Medical Device Registration (CMDR) in order to be imported and placed on the market in the Philippines. For the latest information on regulatory requirements, please see our Medical Device Registration page. (Note a grace period for compliance may apply depending on risk class and Notification status.)
Technical data requirements specific to stand alone medical device software may include:
[specifications of software, verification and validation reports/ registration requirements – Design Validation and Verification]
Software will also need to abide by the Data Privacy Act of 2020, RA10173 by the National Privacy Commission and The Health Privacy Code of the Philippines, AO2016-0002.
License maintenance is an important consideration for manufacturers selling medical devices in the Philippines as failures to comply could lead to loss of market access and significantly affect sales. License Maintenance in the Philippines consists of paying an Annual Retention Fee, maintaining advertising compliance and obtaining approval prior to importing products that have changed from the original Registration Certificate.
Manufacturers of software only devices should pay particular attention to changes to labeling and Instructions For Use (IFU).
In the Philippines, the License holder must be involved in the customs clearance process. However, since most software is downloaded from the internet instead of physically imported, this requirement does not apply to SaMD without physical form. Some manufacturers of SaMD choose a business model to charge hospitals directly for image processing. For manufacturers that choose not to partner with a local commercial partner, Asia Actual is able to process the invoices while the manufacturer focuses on creating demand remotely or through a hired sales person/team in country. Local invoices are subject to 12% VAT, 2% Withholding tax, 30% income tax, and an annual business tax.
Contact Asia Actual for assistance with your medical device registration in the Philippines or to confirm the cost and time lines that apply to your specific devices of interest. Asia Actual has experienced, top level consultants in the Philippines to manage the application process.
“Software’s regulatory requirements depend on the risk associated with the device and implementation status of AO 2018-002.”
US: +1 512 898-9222
SG: +65 3138-4148
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