On June 7th, MDA launched the first phase of the pilot survey for the implementation of Unique Device Identification (UDI) in Malaysia. The survey will be conducted in two phases, involving the following establishments and timelines (dates updated July 30 2024): Phase 1: Class D Medical Device Establishments – June 7, 2024, to August 15, […]
Malaysia: Pilot Survey for Unique Device Identification (UDI) Read More »
On July 9, Thai FDA shared the following draft guidelines regarding license transfer and brand name amendment: The guidelines are set up for the applications that are eligible for referencing existing documents or document transfer from approval license which do not require an expert review of the documents. It covers three main scenarios: (1) When
On July 10, Thai FDA shared an infographic regarding signage requirement for affected stakeholders: The registrants of an establishment for manufacturing or importing/licensed sellers of medical devices must arrange for signage display. The Signage must be displayed for the following: Medical device manufacturing facility Medical device selling facility Medical device importing facility Medical device storage
Starting 01 July 2024, Payment via over-the-counter using LBP Oncoll Deposit Slip will be temporarily suspended until further notice. During this period, FDA encourages all concerned parties to utilize the following payment channels: LBP LinkBiz Portal DBP BancNet Bills Payment Over the Counter (for applications included in the Annexes of FDA Advisory No. 2024-0320) Furthermore, the
On 28 June 2024, the Vietnam Ministry of Finance issued Circular No. 43/2024/TT-BTC prescribing fees and charges to remove further difficulties for enterprises and support production and business activities. This circular reduces the fees and charges for some procedures from those regulated in previous guidelines. Accordingly, all fees and charges in the medical sector are
Vietnam: New Circular Regulating Fees and Charges Affecting the Medical Sector Read More »
In an announcement last June 26, 2024, TFDA released an additional list of experts, expert organizations, government agencies, or private organizations, both domestic and international, to perform the evaluation of academic documents on medical devices. This is according to Section 35/2, paragraph 1 of the Medical Devices Act B.E. 2551, as amended by the Medical
Massage equipment and vibrating devices are commonly used for various purposes, but not all of them are classified as medical devices. The classification depends on their intended use and the claims made by the manufacturer. Here’s a breakdown of how these devices are classified according to the Medical Device Act B.E. 2551 (2008), as amended
Thailand: Classifying Massage Equipment and Vibrating Devices as Medical Devices Read More »
On May 20, 2024, the Ministry of Public Health of Thailand issued a notification regarding medical devices prohibited from direct sales or direct marketing under the law governing Direct Sales and Direct Marketing. By Section 5, Paragraph One, and Section 6 (12) of the Medical Device Act B.E. 2551 (2008), the Minister of Public Health,
The Minister of Public Health, upon the advice of the Medical Device Committee, established the criteria and methods for the transportation, storage, destruction, or disposal of medical devices under the Authority conferred by Section 5, Paragraph One, and Section 6 (16) of the Medical Device Act B.E. 2551 (2008). Under this regulation, the registrants of
The Secretary-General of the Food and Drug Administration hereby issues the draft announcement as follows: Section 1: This Announcement shall be effective from the day following its publication in the Government Gazette. Section 2: Guidelines for submitting applications for medical device advertising that requires academic document evaluation are as follows: Display of advertising messages that
Following the authority conferred by Section 5(1) of the Medical Device Act B.E. 2551 (2008) and Section 41(7) as amended by the Medical Device Act (No. 2) B.E. 2562 (2019), the Minister of Public Health hereby issues the following announcement: The registrant shall prepare signage to display the supervisor’s name and qualifications to control production,
On May 20, 2024, the Ministry of Public Health of Thailand issued a notification governing medical devices that require Supervisors for Control of Production, Import, or Sale and the qualifications, number, and duties of such supervisors, B.E. 2567 (2024). Medical device operators must appoint at least one supervisor with qualifications and duties for production, import,
Effective 1st July 2024, a new registration initiative – NextGen MD, is available for product owners who are keen to market their next-generation MDs/IVDs in Singapore. The registration requirements follow the latest GN-15: Guidance on Medical Device Product Registration, with an additional task of completing the NextGen MD form. This form consists of two parts,
In a newsletter article last June 28, 2024, the Thailand Food and Drug Association (TFDA) shared news that they will be collaborating with agencies to discuss the draft of medical device laws to adjust the registration of diagnostic test kits and reagents for COVID-19 to be based on risk classification of medical devices and international
The procurement process through the e-Catalogue website of the the Procurement Goods/Services (LKPP: Lembaga Kebijakan Pengadaan Barang dan Jasa Pemerintah) under the Ministry of Health (MoH) of Indonesia has been updated. The MoH has extended the listing deadline until 31 December 2024. In addition, the Freezing and Unfreezing process in the e-Catalogue, regulated under the MoH
Indonesia: Listing Product Schedule Update in the Ministry of Health e-Catalogue Read More »
On April 25, 2024, the Ministry of Public Health (MOPH) announced the Criteria, Methods, and Conditions for Assembly to Install Medical Devices Outside the Place Specified in the Certificate of Establishment, License, Notification license, or Listing License, B.E. 2567 (2024). The registrant, licensee, notifier, or the listing licensee who assembles and installs medical devices outside
The Thai Food and Drug Administration (TFDA) implemented a new notification aimed to simplify the registration process of medical devices under the “Specification of Data, Documents, or Evidence Not Required for Submission under the Ministerial Regulations on the Permission and Issuance of Licenses for the Manufacturing or Importation of Medical Devices and the Notification License
Thailand: Simplification Of The Registration Process For Medical Devices Read More »
On June 4, 2024, the Thailand Food and Drug Administration (TFDA) announced the list of foreign agencies recognized or accepted for inspection or certification of medical devices or its establishments. The details are as elaborated below: No. Agency Condition 1 Therapeutic Goods Administration (TGA) It is a medical device that has been approved to be
The Medical Device Authority (MDA) has announced the implementation of electronic establishment licenses, effective from June 5, 2024. Once the application is completed (status complete) and the license fee has been paid, establishments may download the establishment license from the MeDC@St2.0+ system. Additionally, MDA will continue to issue physical establishment license certificates for use by
The Medical Device Authority (MDA) has announced the revocation of Circular Letter No. 1/2022, which exempted the compliance assessment process by Conformity Assessment Bodies (CAB) for the registration of COVID-19 test kits under the Medical Device Act 2012. Effective February 23, 2024, COVID-19 test kit registration must adhere to the procedures outlined in the MDA/GL/IVD-1
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.
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
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
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