{"id":8204,"date":"2018-11-12T12:07:07","date_gmt":"2018-11-12T11:07:07","guid":{"rendered":"http:\/\/www.thema-med.com\/registrare-un-dispositivo-medico-nelle-filippine\/"},"modified":"2023-10-06T10:13:55","modified_gmt":"2023-10-06T08:13:55","slug":"medical-device-registration-in-philippines","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/medical-device-registration-in-philippines\/","title":{"rendered":"Medical device registration in Philippines"},"content":{"rendered":"
\"filippine\"<\/span><\/div>
Regulatory Authority<\/b><\/h5>\n

Food and Drug Administration (FDA) headed by the Department of Health<\/p>\n

Classification<\/strong><\/h5>\n

A, B, C, D<\/p>\n

Quality system<\/b><\/h5>\n

ISO 13485:2016<\/p>\n

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<\/i><\/span>The information on this page is valid and current as of June 2018. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and\/or inaccuracy of the information received concurrently with or following the publication of this page Disclaimer<\/a><\/strong><\/em><\/span><\/div><\/div><\/div><\/div>

Medical Devices manufacturers may not import, export, manufacture, distribute or market their products in the Philippines, unless they are notified or registered with the FDA, depending on the device risk classification.<\/p>\n

Class A devices must be notified and consequently the Regulatory Authority issues the Certificate of Medical Device Notification (CMDN). Class B, C and D devices must be registered with FDA, following which the Certificate of Medical Device Registration (CMDR) will be issued.<\/p>\n

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Applicant<\/span><\/h3>\n

Foreign manufacturers shall appoint an Authorized Representative.<\/p>\n

Timeframe and fees<\/span><\/h3>\n

Fees depend on the device risk class. Notification and registration timeframes vary from 3 to 6 months.<\/p>\n

Validity<\/span><\/h3>\n

The ISO 13485:2016: 2016 certification must be renewed annually. The CMDN and CMDR certifications are valid for 5 years.<\/p>\n

Labelling and documentation language<\/span><\/h3>\n

Documentation and labelling shall be provided in English.<\/p>\n

Useful information<\/span><\/h3>\n

In order to comply with the ASEAN Directive on Medical Devices, on January 26, 2018 the Regulatory Authority issued the Administrative Order 2018-0002 changing the registration requirements for Medical Devices. The final implementation will be effective as of April 1, 2019, therefore Manufacturers and Authorized Representatives have 12 months to comply with the updated requirements.<\/p>\n

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    Do you want to market your Medical Device in this Country? Contact us!\n<\/h3>\n