March 8th, 2018
The Guidelines released by the Department of Health concerning Medical Device Registration is in place to be officiated following its publication. This shall be implemented a year after its effective date. Delayed implementation allows sufficient preparation for applicants in securing technical documents crucial to the registration process.
In an aim to align Philippine Regulatory guidelines with the provisions set by the ASEAN Medical Device Directive, the Department of Health has recently released the Administrative Order 2018-0002, which covers the Guidelines Governing the Registration of Medical Devices based on the ASEAN Harmonized Technical Requirements. The Guideline introduces new terminologies, risk classification of medical devices, as well as new sets of documentary requirements for the initial registration, renewal, and medical device listing. Moreover, the guideline expands its scope for medical devices that are intended for research and clinical trials, exhibits, donations, etc. that are not intended for sale.
The new guideline retains the current application process, fees and timelines, maintaining the definition of “Applicant” for medical device registration as any local legal entity that has the device establishment license approval from FDA Philippines. Still, the biggest regulatory impact on the medical device industry is that starting on March or April 2019, all medical devices are required to obtain the approval of FDA Philippines prior to any marketing or distribution activities. Other key differences between the current and new guidelines are highlighted as follows:
The documentary requirements for Notification, Registration, Medical Device Listing, Renewal, are attached as annexes to the Administrative Order.
The new guideline does not include the schedule of fees for authorization processes. Currently, a separate Administrative Order for the new schedule of fees is still under development.
Moreover, the new guideline only applies for all medical devices to be sold, imported, exported, manufactured, and used in the Philippines. Provisions for in-vitro diagnostic and refurbished medical devices, however, are not included within the scope of this guideline. Separate Administrative Orders shall be issued for these types of devices.
Implementation Timeline and Phases
The new guideline has yet to be officially published to the general public. The 1-year countdown to implementation shall be effective upon publication, hence the start date is still tentative. however, FDA officials are eyeing the implementation of new guidelines on March 2019.
Automatically affected upon implementation are all the Adoption of Common Submission Dossier Template for all Registrable Medical Devices; the Notification of all Class A medical devices; and the Listing of devices for research, exhibits, donations, etc.
The implementation process for non-registrable medical devices shall be carried out in three phases as outlined in Section IX of the said guideline. Phases of implementation are hereby summarized as follows:
$11. Phase 1: For Non-registrable devices classified under Class B, C and D, Notification shall be applied.
$12. Phase 2: Notification for Non-registrable devices classified under Class D shall cease during this phase. Hence, the requirements for Registration of Class D medical devices will apply.
$13. Phase 3: Notification for Non-registrable devices classified under Classes B and C shall cease during this phase. Hence, the requirements for Registration of Class B and C medical devices will apply.
The new regulation has two implementation schedules, one for currently registrable devices, and another for non-registrable devices.
For a clearer picture, the following figure shows a summary.
Figure 1. Implementation Timeline for Registrable Medical Devices. The schedule of implementation for Registrable Medical Devices will tentatively commence by the end of first quarter of the year 2019. All Registrable Devices under Class A shall apply for Notification, while devices under Class B, C and D will follow the Registration Process in CSDT format.
Figure 2. Implementation Timeline for Non-Registrable Medical Devices. As for non-registrable medical devices, these shall undergo a transition stage, hence the new regulation shall be implemented in three phases.
Most importantly, the Center for Device Regulation Radiation Health & Research (CDRRHR) shall release the keyword list of medical devices with their corresponding risk-based classification to assist the industry in verifying the risk class of medical devices.
The industry is also in talks with the CDRRHR for an earlier voluntary transition period for Phase 1 this year. The officials have yet to decide on the feasibility of accepting voluntary notification of currently exempted medical devices before the onset of mandatory applications in March 2019.
The public has been requested to await further Circulars on the shifting of notification to registration of currently exempted devices, which will happen in the last implementation phase of the new guideline.