May Regulatory Affairs Updates
Andaman Medical
Regulatory affairs and market access experts for medical devices in Southeast Asia
Hi!👋
Here’s your monthly update on regional regulatory happenings!
Stay on top of the latest regulatory developments in the ASEAN region with our expert insights. From medical device regulations to latest updates, we've got you covered.
Indonesia 🇮🇩
This regulation means that starting July 1, 2024, medical device distributors in Indonesia must possess a GDPMD certificate to obtain marketing authorization for their products. Read more here.
These guidelines emphasise the requirements and supervision for the circulation of medical devices and household health supplies through electronic systems in Indonesia to ensure safety, quality, and transparency. Find out more about the update here.
Malaysia 🇲🇾
The Medical Device Authority (MDA) encourage submitting medical device re-registration applications one year before expiration via MeDC@St 2.0+system to avoid deactivation. Learn more about it.
Through this circular, MDA mandates strict registration guidelines for medical devices from countries with trade restrictions, replacing Circular No. 4/2014. Delve deeper into the circular here.
Thailand 🇹🇭
With this exemption, Thai FDA no longer requires hard copies of ID, household registration, and company affidavit for direct contacts, streamlining processes. Find out more about this exemption.
Vietnam 🇻🇳
This decision regulates the selection of medical devices and testing supplies eligible for price negotiation, outlining the process for contractor selection and price negotiation based on various criteria. Learn more here.
Recommended by LinkedIn
Singapore 🇸🇬
Medical device manufacturers can now use Singapore HSA approvals to expedite registration in Hong Kong starting April 2, 2024. For more information, click here.
Key Highlights ✨
We’re excited to announce that we’d be visiting Medical Taiwan on 20-22 June; as well as Medlab Asia & Asia Health on 10-12 July!
If you'd be in the vicinity and would like to touch base, get in touch with us for more information.
Andaman Medical Philippines Team's Fun-Filled Bonding Experience at Riverdale Outdoor Camp 🌄
The Andaman Medical Philippines (AMP) Team recently embarked on a short trip to the Riverdale Outdoor Camp in Alfonso, Cavite, where they engaged in a series of activities designed to help relax, provide some fun and strengthen their bond and camaraderie.
The activities were a huge success, with Ms. Melody's team emerging victorious against Ms. Ivy's team in an exciting 3-2 match, proving that a little friendly competition can go a long way in bringing people together. The team also had quality time bonding over a delicious dinner. After the feast, the team also exchanged stories, building a closer connection with each other.
In the morning, after a delicious spread of a boodle fight breakfast and a quick dip in the pool to cool off, the team headed back to the office, feeling refreshed and ready to tackle the week's tasks with renewed energy and enthusiasm.
The trip was a testament to the power of team building and the importance of taking time to connect with colleagues on a personal level. By sharing these moments, the AMP Team is better equipped to work together more effectively and support each other in their respective roles, all while having a blast in the process!
Connect with us! 📨
Our expert in-house team is available for consultation in over 7 SEA countries!