April Regulatory Affairs Updates

Hey there,

We’re back again with your monthly dose of regulatory updates!👋

As we move forward to navigate the ever-evolving landscape of medical regulations, let us provide you with some vital insights that keep you updated on current affairs across the ASEAN region.

Indonesia 🇮🇩

Listing Product Schedule Update in the Ministry of Health e-Catalogue 

Announcement from the Indonesia Ministry of Health on the updated timeline for the e-Catalogue listing, that has been extended until 30 June 2024. Learn more about the updated timeline.

Decree Of The Minister Of Health Of The Republic Of Indonesia Number HK.01.07/Menkes/163/2024 About Consolidated Display on Sectoral Electronic Catalogue 

The Indonesia's Minister of Health decree aims to streamline and enhance accessibility to information on medical devices and equipment, promoting transparency and efficiency in the procurement process. Get to know more about it.

Philippines 🇵🇭

Extension of the Regulatory Flexibility for Class B, C, and D Medical Devices that are not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A

Know more about the extension of regulatory flexibility for certain classes of medical devices in the Philippines, specifically for Class B, C, and D medical devices. How does this extension of regulatory flexibility help you?

Extension of Transition Period for Licensing of Retailers of Medical Devices

The extension allows retailers more time to comply with licensing requirements and ensures a smooth implementation of regulations while providing continued access to medical devices for consumers. Learn more about it.

Malaysia 🇲🇾

Announcement on Faster Approval for Establishment Licence Application

Here are the new measures implemented by the Malaysian Medical Device Authority (MDA) that’s aimed to expedite the approval process for establishment licences. Learn how this can impact your licence application process.

Establishment Licence Information By The Malaysian MDA

Get new insights regarding the establishment licence requirements by the Malaysian Medical Device Authority (MDA) and the importance of compliance to regulatory standards for companies involved. Get to know the details here.

Cancellation of the Regulation Governing the Exemption from the Compliance Assessment Process by the Compliance Assessment Body (CAB) for the Registration of COVID-19 Test Kits

The cancellation of exemption from the Compliance Assessment Bodies (CABs) emphasises the importance of adhering to compliance assessment processes for COVID-19 test kits. Here’s how it can impact you.

MDA Announced Regulation Governing the Implementation of the Policy of One License for Each Establishment Role

Malaysian Medical Device Authority (MDA)’s new regulation helps to streamline licensing processes by assigning a single licence to each establishment for their specific role in the medical device industry. Here’s how you can benefit from it.

Vietnam 🇻🇳

Decision on the Criteria and Principles for the ASEAN CSDT Assessment of Non-In Vitro and In-Vitro Medical Devices

This decision emphasises the need to ensure consistent standards and uniform market access for medical devices across ASEAN. Learn more about the assessment criteria.

Singapore 🇸🇬

Updates To Cybersecurity Labelling Scheme For Medical Devices [CLS(MD)] Sandbox

Know the changes made to the program and how it allows medical device manufacturers to test their product’s cybersecurity features in a controlled environment. Learn more about the updates.

Read all regulatory updates here

Key Highlights ✨

We were thrilled to be a part of the China International Medical Equipment Fair (CMEF) in April.🎉 

Happy to be part of the discussions and exchange insights with industry experts that shape the future of healthcare. 

Reach out to us! 📨

Our expert in-house team is available for consultation in over 7 SEA counties! 

Kind regards,

Mourad Kholti - CEO

Andaman Medical

Tel. +60 4566 0200 Email: sales@andamanmed.com

Our mailing address is:

Andaman Medical Pte Ltd (Head office)

Tampines Junction Business Center

Level 09-02, 300 Tampines Avenue 5

Singapore 529653

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