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Medical Device Registration of Software (SaMD) in the Philippines
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.
Is stand alone software considered a medical device in the Philippines?
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.
- Smoking succession App – not a medical device
- Irregular heart rate monitoring App – medical device
Philippines’ Medical Device Definition from Administrative Order No. 2018-0002
Medical Device — means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article:
- intended by the manufacturer/product owner to be used, alone or in combination, for human beings for one or more of
- the specific purpose(s) of – diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
- investigation, replacement, modification, or support of the anatomy or of a physiological process;
- supporting or sustaining life;
- control of conception;
- disinfection of medical devices;
- providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and
- which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
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).
- Low Risk
- Low-moderate Risk
- Moderate-high Risk
- High Risk
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.
Device Conformity Assessment
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:
- IEC 62304:2006 Software Life Cycle Processes
- IEC 60601-1 (section 14 deals with Software) for embedded software in a hardware medical device
- IEC 82304-1 for SaMD (extra requirements to IEC 62304) + labeling + PMV
- IEC 81001-5-1 adds requirements for cybersecurity
- IEC 62366-1 adds requirements about man-machine interface ergonomics
[specifications of software, verification and validation reports/ registration requirements – Design Validation and Verification]
License Maintenance (Versions)
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).
Importing and Invoicing Software as Medical Devices in the Philippines
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.
Come Grow With Us
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.
Philippines Regulatory Support
“Software’s regulatory requirements depend on the risk associated with the device and implementation status of AO 2018-002.”
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