Question & AnswerQ&A (ADMINISTRATIVE ORDER NO. 2018-0002)
The purpose is to provide guidelines on the documentary requirements for the registration of medical devices and to align the registration requirements to the Common Submission Dossier Template (CSDT) based on the ASEAN Medical Device Directive.
It applies to all medical devices to be sold, imported, exported, manufactured, and used in the Philippines, except in vitro diagnostic and refurbished medical devices which are covered by separate Administrative Orders.
Medical devices are classified based on the level of risk: Class A (Low), Class B (Low-Moderate), Class C (Moderate-High), and Class D (High).
Class A medical devices require a Certificate of Medical Device Notification (CMDN) issued after complying with the Notification requirements.
They require a Certificate of Medical Device Registration (CMDR) after fulfilling the Registration requirements.
CDRRHR is the regulatory office under the FDA of the Department of Health in charge of regulating medical devices in the Philippines.
Grounds include: manufacturing or selling unsafe devices, misrepresentation or concealment of data, label alteration, medical devices causing unacceptable health risk, submission of falsified documents, and alteration or falsification of issued CMDN or CMDR.
Both CMDN and CMDR are valid for five (5) years and must be renewed every five years after initial approval.
The applicant is given a one-time compliance period of 90 calendar days to correct deficiencies. Failure to comply results in disapproval, but re-application may be submitted within 60 calendar days after disapproval.
The documentary requirements vary by class but generally include legal and technical documents as per Annexes A to E depending on the class, following the CSDT template. The CDRRHR may request additional documents if necessary.
Yes, one application can be filed for medical devices with accessories intended to be sold separately, devices from the same manufacturer but different plants, medical device systems, devices with same intended use but differ in raw materials or design, and others as specified.
'Notification' refers to the process of seeking authorization to manufacture, import, export, sell and/or distribute Class A medical devices in the Philippines.
'Registration' is the process of approval prior to engaging in manufacture, importation, exportation, sale, distribution, use, testing, promotion, advertisement, or sponsorship of medical device products.
Applications filed after the expiry date shall be penalized as per existing rules; filing after 120 calendar days of expiration will be considered as an initial application and sale/distribution must stop until approval.