With Overseas Medical Equipment Technical Assistants (OMETA), Qualteh has held an online seminar about regulatory updates in ASEAN on 27th October, where we covered major updates in the Philippines, Thailand, and Malaysia. It was such an honor for Qualtech to speak to more than 120 professionals from numerous, distinguished Japanese manufacturers. In this article, we have summarized what we provided during the seminar, which many manufacturers who are currently or will be participating in business in the three countries may want to pay attention to.
Regulatory Update in the Philippines:
• Between 2019 to 2020, the Philippines FDA has announced two major updates. Firstly, PFDA will start to adapt to ASEAN Harmonized Requirements from 2019 onwards, as mentioned in the FDA Circular No. 2020-001. Initial implementation of ASEAN Harmonized Requirements.
• Administrative Order No. 2020-0017. Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration, sets the guidelines on a uniﬁed, harmonized, and streamlined licensing requirements of the PFDA to hasten its approval process and strengthen its post-marketing surveillance activities.
Regulatory Update in Thailand
• ThaiFDA is currently in an important transition phase from policy-based classification to risk-based classification of medical devices. Medical Device Act (Issue 2) B.E. 2562 (2019) has been enacted in April 2019 onwards. Following that, ThaiFDA has also announced the Medical Device Risk Classification 2019.
• Prior to the complete transition phase from policy-based classification to the risk-based classification of medical devices, ThaiFDA has announced the guidance document for Technical Documents Preparation for Inspection Purpose.
Regulatory Update in Malaysia
• Malaysia Medical Device Authority (MDA) published the guideline and guidance documents to help the establishment to understand more about the registration of medical devices in the market.
• The guidance documents covered from pre-market to post-market. In the pre-market, the guidance documents show the required documents need to be submitted to the authority.
• For post-market activity, MDA provides guidance which covered recall, adverse event (AE), and Field Corrective Action (FCA).
• From mid-2019 until the second half of year 2020, MDA published 20 new guidance for both pre- and post-market activity.