Following the enactment of the One License Per Establishment Role Policy outlined in the “General Directive of the Minister of Health No. 1/2024, in accordance with the provisions of the Medical Device Authority Act 2012 [Act 738]: Implementation of the One License Per Establishment Role Policy,” the Medical Device Authority (MDA) of Malaysia has declared […]
On May 23, 2024, the Medical Device Authority (MDA) of Malaysia issued a draft guidance document for the fifth edition of Change Notification for Registered Medical Devices, designated as MDA/GD/0020. The main highlights from this draft guidance document are as follows: Establishments are required to identify the appropriate application type, either Single Application or Multiple
On May 21, 2024, the Indonesian Ministry of Health (MoH) issued a letter numbered FR.03.01/E.V/1179/2024 regarding Filling the New System of Pharmacy and Medical Device Dictionary (KFA), which was signed on 14 May 2024. KFA is a dictionary that contains unique codes for pharmaceutical products and medical devices and can be used and integrated into
Thai Food and Drug Administration (FDA) announced the Criteria, Methods, and Conditions for Evaluating Academic Documents, Analysis, Establishments Inspection or Inspections for Consideration and Permission of Medical Device Licensing, B.E. 2567 (2024). The goal is to streamline the licensing process for medical devices while maintaining high quality, efficiency, and safety standards. Highlights of the announcement
The Thailand Food and Drug Administration (TFDA) issued a draft announcement governing the highest rates of expenses for document evaluation, analysis, business establishment inspection or medical device inspection monitoring, auditing, or surveillance to control the manufacturing, import, and sale of medical devices. This announcement will be effective after its issuance date in the Royal Gazette.
The Thailand Food and Drug Administration (TFDA) issued a draft announcement governing the expenses for document evaluation, analysis, establishment inspection, or medical device inspection for monitoring, auditing, or surveillance to control medical device manufacturing, import, and sale. This announcement will be effective 90 days after issuance in the Royal Gazette. The expenses for document evaluation,
On May 23, 2024, the Medical Device Authority (MDA) of Malaysia issued a draft guidance document for the fifth edition of Change Notification for Registered Medical Devices, designated as MDA/GD/0020. The main highlights from this draft guidance document are as follows:• Establishments are required to identify the appropriate application type, either Single Application or Multiple
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. Accordingly, the list of
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. Simultaneously, as a form
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. The HSA issued this information via the April 2024 Nexus Newsletter. This means that valid registration approvals could be used to demonstrate conformance to the Essential Principles of
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 circulation of medical devices and
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 Number 4 of 2014 concerning
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 imported from or exported to
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 update aims to enhance efficiency
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 users to make informed purchasing
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 establishments that act as authorized
On April 2nd, 2024, the Medical Device Authority (MDA) of Malaysia announced the cancellation of the Circular of the Authority for Medical Devices (PBPP) Number 1/2022: Exemption from the Compliance Assessment Process by the Compliance Assessment Body (CAB) for The Registration of Covid-19 Test Kits. This requirement applies to manufacturers who want to register their
The FDA Circular No. 2021-021, which took effect on 18 December 2021, was issued to provide guidelines on the licensing of retailers of medical devices in the Philippines, as well as acting as a supplement for the previously issued Administrative Order (AO) No. 2020-0017 regarding the simplification of the requirements and processes for initial, renewal,
On March 25th, 2024, the Medical Device Authority (MDA) of Malaysia published an announcement regarding faster approval for establishment license applications. The complete applications will be processed within 14–21 working days after the review officer receives them. The following elements will be reviewed during the evaluation process: An updated Letter of Authorization (LOA) with accurate
Malaysia: Announcement on Faster Approval for Establishment License Application Read More »
On March 25th, 2024, the Medical Device Authority (MDA) of Malaysia posted an announcement regarding Establishment License Information. Per Section 15 (1) of the Medical Device Act (Act 737), it was stated that no establishment shall import, export, or place in the market any registered medical device unless it holds an establishment license granted under
Malaysia: Establishment License Information By The Malaysian MDA Read More »
The Philippines’ Food and Drug Administration (FDA) previously issued FDA Circular No. 2021-021, supplementing the Administrative Order (AO) of the Department of Health No. 2020-0017, which took effect on 18 December 2021. Section IX of the said Circular stated that all retailers should be given 2 years from the circular’s effectivity to comply with its
On April 01, 2024, the Bureau of Procurement of Goods and Services (BPBJ: Biro Pengadaan Barang dan Jasa) Ministry of Health socialized a Decree of the Minister of Health of the Republic of Indonesia No. HK.01.07/MENKES/163/2024 which was assigned on 26 February 2024 about Consolidated Display on Sectoral Electronic Catalogue Ministry of Health. The legal
During the harmonization to ASEAN requirements, the Philippines Food and Drug Administration (PFDA) aims to prevent a negative impact on the supply of medical devices by issuing past provisions FC No. 2021-002A, FC No. 2021-002B, and FC No. 2021-002C (valid until Mar 31, 2024) which provide regulatory flexibility to all Class B, C, and D
In the first quarter of 2024, The Department of Infrastructure and Medical Equipment released Decision No. 166/QĐ-BYT and Decision No. 490 / QĐ-BYT regarding the issuance of criteria and principles for assessment of the general technical documentation for Non-In Vitro and In-Vitro Medical Devices following ASEAN regulations (CSDT). They have provided the principles for evaluating
The Procurement Goods/Services (LKPP: Lembaga Kebijakan Pengadaan Barang dan Jasa Pemerintah) under the Indonesia Ministry of Health announces the updated timeline for the e-Catalogue listing has been extended until 30 June 2024. Stakeholders can still list their products in the e-Catalogue during the timeline announced until further notice. With regard to Freeze and Unfreeze regulated
Indonesia: Listing Product Schedule Update in the Ministry of Health e-Catalogue Read More »
The Philippines Food and Drug Administration (FDA) issued an Advisory No. 2024-0498 dated 06 March 2024, entitled “Delisting of COVID-19 Medicines and Devices from the List of VAT-Exempt Health Products”, informing the stakeholders and all concerned clients that the products used for COVID-19 shall no longer be VAT-Exempted, effective 01 January 2024. This action is
The Health Sciences Authority (HSA) of Singapore made several key updates to align with current International Medical Device Regulators Forum (IMDRF) regulatory recommendations regarding software/programmed or programmable medical devices. Product owners that are involved in Software as a Medical Device (SaMD) either being standalone or embedded within the Medical Device are highly suggested to be
As of December 2023, the Policy Institute for Procurement Goods/Services (Lembaga Kebijakan Pengadaan Barang dan Jasa Pemerintah (LKPP)) under Ministry of Health (MOH) Indonesia has announced the schedule of Product Listing in e-Catalogue system for Health Facility in Indonesia is open until 31 March 2024 or until further notice. For stakeholders who plan to list
The Medical Device Authority (MDA) has released the Guidance Document, MDA/GD/0005, Second Edition, entitled “General Medical Device – Grouping” to assist the industry and healthcare professionals in achieving compliance with the Medical Device Act (Act 737) and its associated regulations. The guidance document has been updated to offer direction on determining the appropriate grouping for
On March 7th, 2024, the Medical Device Authority (MDA) of Malaysia, issued Medical Device (Exemptions) Order 2024 where the Medical Device (Exemption) Order 2016 [P.U. (A) 103/2016] is revoked. The legislation covers the following: Exemption from Registration of Medical DevicesAny medical device is exempted from registration under section 5 of the Act by the Minister
Malaysia: MDA Announced Medical Device (Exemptions) Order of 2024 Read More »
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