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PHILIPPINES TO HOST ASEAN MEDICAL DEVICE COMMITTEE MEETING / TRAINING

The 8th ASEAN Medical Device Committee Meeting (AMDN) will take place in Manila from August 4-8, 2019. The meeting will be hosted by the Philippines Association of Medical Device Regulatory Affairs Professionals (PAMDRAP) together with the Philippines Food and Drug Administration (FDA).

Government regulators and technical committee members will gather for closed door meetings.  At the same time, Industry Training Sessions will be held on Wednesday, August 7th and Thursday, August 8th including a Public-Private Forum on Thursday afternoon from 2:00 to 5:30.  The full program will conclude with a Gala Dinner on Thursday evening.

Industry stakeholders are invited to attend the trainings, forum and Gala dinner. Information on registration process and fees are available here: www.pamdrap.org/amdc2019. 

Asia Actual personnel will be in attendance and report on significant developments. Contact us to arrange a briefing.

PHILIPPINES DELAYS LAUNCH OF NEW MEDICAL DEVICE REGULATIONS

The Philippines FDA intended to implement the first two phases of the new medical device regulatory system (known as Administrative Order 2018-0002) on April 11, 2019, however the implementation date has been delayed.  Extra time is needed for the CDRRHR to finalized guidelines for classification and grouping, etc.

No formal guidance on the new target implementation date has been announced, but it is expected to be several weeks later. In the meantime, the CDRRHR will continue to accept and process Certificate of Product Registration (CPR) and Certificate of Exemption (COE) applications under the current Rules.

Details of the AO 2018-0002 requirements were reported earlier and available on the Asia Actual website here

Asia Actual has a strong regulatory team in Manila to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.