Andaman Medical

13/11/2024

Thank you Artrend Interior Studio ! Our Penang team is very happy with the new office you designed and built for us! 💪🏽🙏🏽

30/05/2024

Thailand 🇹🇭 update:
The Thailand Food and Drug Administration (TFDA) issued a draft announcement governing the expenses for document evaluation, analysis, establishment inspection, or medical device inspection.

Learn more about what this means for your business below 👇

The TFDA Thailand issued a draft announcement governing the expenses for document evaluation, analysis and inspection. Read more here.

28/05/2024

Malaysia 🇲🇾 update: On May 23, 2024, the Medical Device Authority (MDA) of Malaysia issued a draft guidance document for the fifth edition of Change Notification for Registered Medical Devices, designated as MDA/GD/0020.

Learn more about what this means for your business below 👇

The MDA of Malaysia issued a draft guidance document for the fifth edition of Change Notification for Registered Medical Devices.

22/05/2024

Vietnam 🇻🇳 update:
On May 14, 2024, the Ministry of Health of Vietnam issued Circular 05/2024/TT-BYT regulating the list of drugs, medical devices, and testing supplies eligible for price negotiation and the process and procedures for selecting contractors for bidding packages and applying for price negotiation. This circular takes effect from May 15, 2024.

Learn more about what this means for your business below 👇

Issuance of New Circular Governing the List of Products Eligible for Price Negotiation and Its Processes by Vietnam’s Ministry of Health

21/05/2024

Malaysia 🇲🇾 update:
Per the MDA/GL/08 entitled “Guidelines for Re-Registration of Registered Medical Devices,” applications for medical device re-registration are to be submitted online via the MeDC@St 2.0+ system one year before the certificate expiration date. The re-registration button will become available in the system one year prior, allowing establishments to submit their applications.

Learn more about what this means for your business below 👇

Per the MDA/GL/08 entitled “Guidelines for Re-Registration of Registered Medical Devices,” applications are to be submitted 1yr in advance.

14/05/2024

Singapore 🇸🇬 update:

Medical device companies can use the registration approvals accorded by the Health Sciences Authority (HSA) of Singapore to enter the Hong Kong market starting 02 April 2024.

Learn more about what this means for your business below 👇

Medical device companies can use the registration approvals accorded by HSA Singapore to enter the Hong Kong market starting 02 April 2024.

13/05/2024

Indonesia 🇮🇩 update:

Indonesia Ministry of Health (MoH) shared Guidelines for the Circulation of Medical Devices and Household Health Supplies through Electronic Systems which was signed on 05 April 2024.

Learn more about what this means for your business below 👇

Guidelines for the Circulation of Medical Devices and Household Health Supplies through Electronic Systems which was signed on 05 April 2024.

09/05/2024

Indonesia 🇮🇩 update:

The Indonesia Ministry of Health has issued an Announcement about the Implementation of the GDPMD Certificate (CDAKB: Cara Distribusi Alat Kesehatan yang Baik) as a Requirement for Marketing Authorization that was signed on 30th April 2024.

Learn more about what this means for your business below 👇

On May 07, 2024, the Indonesia MoH issued an Announcement about the Implementation of the GDPMD Certificate.

08/05/2024

Malaysia 🇲🇾 update:

The Medical Device Authority of Malaysia (MDA) has issued Circular Letter No. 1 of 2024 titled “Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions.”

Learn more about what this means for your business below 👇

MDA Circular 1/2024 Medical Devices Imported from or Exported to Countries with No Diplomatic Relations Malaysia Subject to Trade Restrictions

07/05/2024

Thailand 🇹🇭 update:

Thai FDA Announces Streamlined Procedures: Exemption of Hard Copy Documents for Regulatory Transactions.

Learn more about what this means for your business below 👇

Thai FDA has announced exemptions for certain hard copy document submissions to streamline processes and administrative load on registrants.

25/04/2024

Singapore 🇸🇬 update:
The Cyber Security Agency (CSA) of Singapore encourages Medical Device Manufacturers to join the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] Sandbox, which started 20 October 2023 and will end in July 2024.

Learn more about what this means for your business below 👇

The CSA Singapore encourages Medical Device Manufacturers to join the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] Sandbox

24/04/2024

Malaysia 🇲🇾 update:

The MDA has announced regulation governing the implementation of the policy of one license for each establishment role

Concerning the Cancellation of the Medical Devices Authority’s (MDA) Circular Letter No. 1/2014, Establishments are no longer permitted to combine license applications for the operations of manufacturers, authorized representatives, importers, or distributors under the same establishment license.

Learn more about what this means for your business below 👇

https://andamanmed.com/malaysia-mda-announced-regulation-governing-the-implementation-of-the-policy-of-one-license-for-each-establishment-role/

Establishments are no longer permitted to combine applications for the manufacturers, AR, importers or distributors under the same license.