In the Philippines, the medical device industry relies heavily on imports for its products. Whether these products are made domestically or imported from abroad, it is mandatory for all medical devices to undergo registration. The registration process is overseen by the Philippines Food and Drug Administration (FDA) through the Center for Device Regulation, Radiation Health, and Research (CDRRHR). It is crucial for manufacturers or importers to navigate this process and ensure compliance with Philippine regulations in order to bring their devices to the market.
There have been significant changes to the medical device regulations in the Philippines. The PFDA has introduced new regulations in 2020 and has provided manufacturers with transition timelines to adhere to. Additionally, expedited approval of medical devices and in vitro diagnostics (IVDs) is allowed by the PFDA if approvals have been obtained from ASEAN countries.
Medical Device Classification in Philippines
In terms of medical device classification, products are categorized into four classes (A, B, C, and D) based on their intended use and level of risk. These classifications align with the ASEAN Medical Devices Directive (ASEAN MDD). If there is any uncertainty regarding classification, device owners can seek official feedback from the PFDA. The registration requirements and pathway for each class of device may vary.
Grouping of medical devices in Philippines
The medical devices, along with its various parts and supplementary items, can be consolidated and undergo a streamlined application process.
A medical device and its accompanying accessories that can be purchased individually;
Medical devices produced by the same manufacturer and distributed simultaneously, yet manufactured in different facilities;
Medical devices designed to be utilized together as a set;
Medical devices produced using the same manufacturing process and serving the same purpose, but differing in terms of materials and/or designs;
Medical devices constructed from identical materials, but featuring variations and intended for different uses.
Local Representation in Philippines
In order to register and sell their medical devices in the Philippines, the international medical manufacturing company has the option to either create a subsidiary, appoint a distributor, or engage a third-party representative.
Medical Device Registration in the Philippines
The regulations for medical devices in the Philippines are currently going through a transition. Prior to their launch in the Philippines, all Class A medical devices and Notified Class B, C, and D medical devices must undergo a pre-approval process. Non-Notified Class B, C, and D medical devices must be notified and obtain a Certificate of Medical Device Notification (CMDN) before April 1, 2024, and must obtain a Certificate of Medical Device Registration (CMDR) during the first renewal cycle. Prior to initiating product registration, companies selling medical devices must obtain a License to Operate (LTO). The approval process in the Philippines varies based on the risk classification of the device.
Class A medical devices, which fall under this classification as "Notified," need to obtain a Certificate of Medical Device Notification (CMDN). Applicants submit their applications through the e-notification portal, which are then evaluated by the Philippines FDA. Once the criteria are met and approval is given, a unique Notification Number is assigned within a span of 4 to 12 weeks.
Class B to D medical devices, falling under this classification, are required to apply for a Certificate of Medical Device Registration (CMDR). Applicants must compile a precise technical dossier in the CSDT format and submit it via email for registration. The application and its accompanying documents are meticulously reviewed by the Philippines FDA. If additional information is required, applicants must provide comprehensive responses. Approval for the CMDR application is typically granted within approximately 180 days once all documents are confirmed to be accurate and complete.
Quality Management System (QMS) Requirements
All Class A, B, C, and D devices require ISO 13485 certification or an audit report from the FDA or Japanese PMDA to certify the quality system of the manufacturing facilities, whether they are legal or actual.
Documents Requirement for the Registration Process
The registration process for medical devices and IVDs in the Philippines requires approval from the home country or reference country. Different documents are needed for registration depending on the risk class of the device, and the language accepted for submission is English. The necessary documents to obtain a device registration certificate in the Philippines include a
License to Operate (LTO)
Proof of payment
ISO 13485 certification
Free Sale Certificate from the country of origin
Device description and features
Indications for use
Pre-clinical studies
Clinical studies
Shelf life and biocompatibility information
Labeling
Certificate of Agreement between the manufacturer and distributor
Validity and Renewal of Certificate
The certificate remains valid for 5 years and must be renewed after the initial approval period. Renewal applications can be submitted 90 days before the expiry date.
License Transfer Requirements in the Philippines
To transfer CMDN/CMDR projects, the current holder's license information needs to be reviewed, and the application requires the original Registration Certificate. The processing time for transfer applications is typically 2 to 3 months. Required documents for the transfer include
Letter of Request
Termination of contract
Original CMDN/CMDR
Complete labeling file
Foreign agency agreement
ISO 13485 certificate.
Navigating the process of registering medical devices in the Philippines can be a challenging endeavor. By thoroughly comprehending the regulatory framework, risk classifications, and device-specific requisites, manufacturers/importers can effectively introduce their medical innovations to the Philippine market.
Artixio presents a streamlined solution for navigating the complex regulatory landscape in the Philippines, leveraging their expertise and thorough understanding of the country's regulatory requirements.
Artixio guarantees a seamless and effective procedure for the registration of medical devices. Their unwavering commitment to excellence and devotion to the success of their clients make them the perfect ally for companies who desire dependable, customized, and skilled support in navigating through the regulatory obstacles in the Philippines.
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