Regulatory updates Archives

Indonesia: Guidelines for the Circulation of Medical Devices and Household Health Supplies (PKRT: Perbekalan Kesehatan Rumah Tangga) through Electronic Systems

May 13, 2024

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. The guideline is intended as a reference for business actors, medical device and Household Health Supplies associations, and other stakeholders in implementing the

Indonesia: Implementation of GDPMD Certificate (CDAKB: Cara Distribusi Alat Kesehatan yang Baik) as a Requirement for Marketing Authorization

May 9, 2024

On May 07, 2024, the Indonesia Ministry of Health issued an Announcement Number FR.03.06/E.V/1095/2024 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. Based on the Regulation of the Minister of Health

Malaysia: Medical Device Authority (MDA) Released Circular Letter No. 1/2024: Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions

May 8, 2024

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.” In accordance with the implementation of Circular Letter No. 1/2024, the procedure for registering medical devices

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

May 7, 2024

Thai FDA has announced exemptions for certain hard copy document submissions to streamline processes and administrative load on registrants. In this announcement, registrants contacting divisions under the Thai FDA authority will no longer be required to furnish hard copies of their ID card, household registration, and company affidavit. This significant

Andaman Medical Regulatory Affairs Update: Singapore

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

April 24, 2024

The CYBER SECURITY AGENCY (CSA) of SINGAPORE encourages Medical Device (MD) Manufacturers to join the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] Sandbox, which started 20 October 2023 and will end in July 2024 The CLS(MD) label indicates the level of cybersecurity provisions and features in the devices and allows

Andaman Medical Regulatory Affairs Update Malaysia

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

April 23, 2024

On April 15th, 2024, Malaysia’s Medical Device Authority (MDA) announced the General Directive of the Minister of Health No. 1/2024 Pursuant to the Provisions of the Medical Device Authority Act 2012 [Act 738], regarding the Implementation of the Policy of One License for Each Establishment Role. This requirement applies to

Regulatory Updates

Indonesia: Guidelines for the Circulation of Medical Devices and Household Health Supplies (PKRT: Perbekalan Kesehatan Rumah Tangga) through Electronic Systems

Indonesia: Implementation of GDPMD Certificate (CDAKB: Cara Distribusi Alat Kesehatan yang Baik) as a Requirement for Marketing Authorization

Malaysia: Medical Device Authority (MDA) Released Circular Letter No. 1/2024: Medical Devices Imported from or Exported to Countries with No Diplomatic Relations with Malaysia Subject to Trade Restrictions

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

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

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

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