The Ministry of Public Health (MOPH) in Thailand issued a draft guidance specifying on three types of medical devices that require a production, import, or sale controller, such as: Viscous products for use in eye surgery Silicone breast implants for implantation in the body Hyaluronic acid injections for the correction of skin defects The draft […]
To ensure the standardized quality, efficiency, and safety of importing or selling medical devices, which is in the interest of consumer protection, it is appropriate to establish a Quality Management System for Importing or Selling Medical Devices. This announcement shall become effective after 1 year from the date of publication in the Royal Gazette. The
The Ministry of Public Health (MOPH) in Thailand issued a draft guidance on criterions, procedures, and conditions for the production of medical devices that are exempt under Section 27(8) B.E. 2008. The key points of the draft guidance are as follows: 1. Production of medical devices by a government agency for testing and calibrating medical
On 31 December 2023, the Ministry of Health (MoH) of Vietnam temporarily froze the online system for the submission of class C and D medical devices. The DMEC website is currently under maintenance starting 01 January 2024 in order to implement the CSDT in accordance with Decree 07/2023/NĐ-CP amending some articles of Decree 98/2021/NĐ-CP dated 08 November
The Health Sciences Authority (HSA) of Singapore announced regulatory fees revision pertaining to health products including medical devices, to be effective on 1 July 2024. The HSA continues to absorb the 1% Goods and Services Tax (GST) increment which was implemented on 1 Jan 2023 and 1 Jan 2024, until further notice. The fee increase
Singapore: Announcement on the List of Regulatory Fee Revision for Health Products Read More »
On December 29, 2023, PFDA issued Circular No. 2023-012, listing Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services. Aligned with DOH AO No. 2020-0035, PFDA oversees facilities using radiation devices to safeguard workers. Emphasizing adherence, PFDA requires providers to establish formal procedures for approval, recognition, or authorization of individual monitoring and related
On 15 December 2023, Health Sciences Authority (HSA) Singapore issued a medical device advisory to alert industry stakeholders to cybersecurity vulnerabilities known as “5Ghoul”. “5Ghoul” affects commercial off-the-shelf (COTS) edge devices using 5G modems. Medical device systems using 5G modems for internet connectivity to function could be attacked in the form of lost, frozen, or
The Center for Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (Philippines) have announced that they will be conducting an inventory and processing of the pending applications for registration of medical devices. In line with this, FDA Philippines has declared an application holiday for CMDN applications from December 15, 2023,
On December 14th, 2023, the Medical Device Authority (MDA) of Malaysia issued a requirement for surveillance report on implantable medical devices on the homepage of Medcast 2.0+ system. This requirement applies to distributors in which as per clause 27.(1) until 27.(3) in GDPMD, establishments that distribute implantable medical devices shall submit a surveillance report to
On December 12th, 2023, the MDA issued 2 (two) guidance documents as follows: MDA/GD/0062 Harmonised Classification of Medical Devices in ASEAN, Second Edition. MDA/GD/0063 Harmonised Borderline Products in ASEAN, Second Edition. These are the highlights of each regulation: Harmonised Classification of Medical Devices in ASEAN 2nd Edition (MDA/GD/0062) Harmonised Borderline Products in ASEAN 2nd Edition
On 5 December 2023, the General Director of Pharmaceuticals and Medical Devices of the Ministry of Health (MoH) of Indonesia released a circulation letter No: HK.02.02/E/2379/2023 regarding the List of SNI ISO/IEC 17025:2017 Accredited Testing Laboratories for Medical Devices and Household Supplies. SNI itself is an abbreviation of Standar Nasional Indonesia or Indonesian National Standards.
On 5 December 2023, the Ministry of Health (MoH) of Indonesia released an announcement letter No: FR.03.01/E.V/2510/2023 regarding the maintenance process of the MoH platform for online licensing system of medical devices and household supplies registration, issuance of online certificates, and issuance of medical devices distribution license (IDAK). Therefore, the following changes will be applied:A.
Based on Law No. 33 of 2014 regarding Halal Product Guarantee, all foreign halal products imported into Indonesia do not require to apply for a local halal certificate, if the foreign halal certificate is issued by a foreign halal institution that has collaborated on mutual recognition of halal certificates with The Halal Product Guarantee Administering
A draft of Government Regulations pertaining to the Implementation of Law No. 17 of 2023 concerning Health was uploaded on the Ministry of Health of Indonesia official website. This regulation was derived from Law No. 17 of 2023, in which one of the clauses mentioned that the further implementation of the law will be regulated
PFDA issued a circular draft for comments regarding the guidelines on the use of the eServices portal system for the initial application of Certificate of Medical Device Notification (CMDN) in line with the PFDA’s goal of delivering efficient government services. Currently, CMDN applications are transacted via the ePortal System. Migrating the mentioned transaction to the
On November 20, 2023, the Health Sciences Authority (HSA) Singapore revised the guidance document on Change Notification applications due to EU MDR and IVDR-related changes to registered medical devices. The identified changes clarified in this update are the following: Changes to IFU related to clarification of existing content and addition of safety information (GMD and
On 14 November 2023, the Vietnam Ministry of Health released Circular 20/2023/TT-BYT repealing some legal regulations issued by the Ministry of Health. By January 1, 2024, the following regulations will be completely revoked: Regulation Regulation Date Provision Directive No. 06/2008/CT-BYT June 27, 2008 The enhancement of the quality of healthcare personnel training Decision No. 379/2002/QD-BYT
Vietnam: Ministry of Health Releases Circular to Repeal Existing Regulations Read More »
On November 16, 2023, the Medical Device Authority of Malaysia (MDA) published an infographicrelated to the medical device registration for In-Vitro Diagnostic (IVD) Medical Devices, where theMDA illustrated the possible ways to register an IVD Analyzer.Based on the infographic, the approaches below can be applied to register an IVD Analyzer:1) IVD AnalyzerThis applies to instruments
Malaysia: Exploring Registration Options: MDA’s Guidelines for IVD Analyzer Registration Read More »
On 8th November 2023, the Medical Device Authority of Malaysia (MDA) published an announcement related with medical device advertisement applications. Commencing December 1st, 2023, the medical device advertisement applications can only be submitted to the MDA via email at advertisement@mda.gov.my. Any hard copies applications will not be processed by MDA. Processing fees shall be paid
Based on the Decision from the Mesyuarat Jawatankuasa Teknikal Pendaftaran Umum 2023, the Medical Device Authority of Malaysia (MDA) has established a transition period for specific requirements until December 31, 2023. Starting January 1, 2024, only the recognized Quality Management System (QMS) standards outlined in Table 1 will be accepted for new and re-registration of
Malaysia: MDA Announces Harmonized QMS Standards for Medical Device Registration in 2024 Read More »
On 26th October 2023, the Medical Device Authority of Malaysia (MDA) published an announcement on the implementation of the use of electronic medical device registration certificate beginning November 1, 2023. With this move for applications approved after 1 November 2023, only electronic medical device registration certificates will be issued by MDA. Instead, the establishment can
On 23rd October 2023, the Medical Device Authority of Malaysia (MDA) published an announcement that the Certificate of Free Sale (CFS) will only be issued for registered medical devices, following the announcement made by the Chief Executive of MDA during MDA High Performance Project on 7th June 2023. With this move, MDA ceases the issuance
The Health Sciences Authority (HSA) Singapore revised Guidance Document: GN-20 Guidance on Clinical Evaluation. The updates reflect their current position on the use of real-world data in medical device clinical evidence as well as clarify related contents with IMDRF guidelines. The HSA is currently soliciting industry comments for this revision. This drafted document provides major
Singapore: Public Comments on Revised Draft of GN-20: Guidance on Clinical Evaluation Read More »
On October 18th, 2023, the Thai Food and Drugs Administration (FDA) provided more explanation to the registration of medical devices scheme, by issuing a pamphlet that can be accessed here (in Thai language). The pamphlet emphasizes more on the registration process based on the risk classification of the medical devices, in which registration of accessories
On October 18, 2023, the Bureau of Goods and Services Procurement (or known as ‘PBJ Bureau’) of the Ministry of Health conducted a socialization on the implementation of Substitution of Imported Medicines and Medical Devices with Domestic Medicines and Medical Devices in the Sectoral e-Catalogue, in an effort to improve and increase the use of
New Process for the Registration Application of Class C and D Medical Devices in Vietnam The Vietnam Ministry of Health posted on the DMEC website on the 10th of October 2023 regarding the new reception and registration process of Class C & D medical devices. Accordingly, the pre-assessment process for Class C and D applications
Vietnam: New Process for the Registration Application of Class C and D Medical Devices Read More »
The Philippines Food and Drug Administration held a virtual public consultation on the draft Administrative Order entitled “Implementing Guidelines on the Schedule of Fees and Charges of the Food and Drug Administration for Licensing, Registration and Other Authorizations and Regulatory Services”, October 27th 2023. The aim of the proposed draft issuance is to rationalize the
On October 2nd, 2023, the Health Sciences Authority of Singapore (HSA) issued a second revision of GL-06: Medical Device Product Classification Guide. This guidance document is applicable to all medical device dealers namely registrants, manufacturers, importers, and distributors. The main highlights of the updated guidance document include the following: To include Eye drops or Eye
Singapore: New Revision of the Medical Devices Product Classification Guide Read More »
The Thailand Food and Drug Administration (TFDA) made an announcement to notify importers and manufacturers in Thailand that the renewal system will be opened starting October 1st, 2023, to December 31st, 2023, for the following certificates: Establishment Registration Certificate Sales License License/ Notification Certificate (applicable for approved products based on the New Regulation) Listing Certificate
Thailand: Updates on Renewal of Certificates for Manufacturers and Importers in Thailand Read More »
On 19 September 2023, Indonesia’s Ministry of State Secretariat released the Government Regulation No. 43 Year 2023: Types and Rates of Non-Tax State Revenues that Apply to the Ministry of Communications and Information Technology, which revokes Government Regulation No 80 Year 2015. This new regulation will be implemented within 60 days from the date of
