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Thailand: Draft Guidance for Sign Displaying the Name and Qualifications of the Production, Import and Sale Controller of Medical Devices

The Ministry of Public Health (MOPH) of Thailand issued a draft guidance specifying information that should be displayed on a sign at the production, import, or sale site of certain types of medical devices. It is mentioned in the draft guidance that the sign shall include: The name and surname of the production, import, or […]

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Thailand: Draft Guidance of Medical Devices Requiring a Production, Import, or Sale Controller

The Ministry of Public Health (MOPH) in Thailand issued a draft guidance specifying on three types of medical devices that require a production, import, or sale controller, such as: Viscous products for use in eye surgery Silicone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

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Vietnam: Temporary Freezing of the Online System for Submission of Class C and D Medical Devices by the Ministry of Health

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

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Singapore: Announcement on the List of Regulatory Fee Revision for Health Products

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

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Singapore: HSA Warns On Cybersecurity Vulnerabilities Potentially Affecting Medical Devices Using 5G Modems

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

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Philippines: FDA Announces Application Holiday for Certificate of Medical Device Notification (CMDN) Applications

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,

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Malaysia: Updated Information on the Surveillance Report of Implantable Medical Devices in Malaysia

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

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Malaysia: Exploring Registration Options: MDA’s Guidelines for IVD Analyzer Registration

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

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Malaysia: MDA’s Medical Device Advertisement Application Transitions to Paperless Starting December 2023

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

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Malaysia: MDA Announces Harmonized QMS Standards for Medical Device Registration in 2024

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

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Vietnam: New Process for the Registration Application of Class C and D Medical Devices

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

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Philippines: Food and Drug Administration released the draft Schedule of Fees and Charges for Licensing, Registration and Other Authorizations and Regulatory Services

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

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Singapore: New Revision of the Medical Devices Product Classification Guide

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

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Thailand: Updates on Renewal of Certificates for Manufacturers and Importers in Thailand

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

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Indonesia: Cost of Device Certification according to Government Regulation No. 43 Year 2023

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

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Vietnam: Updated Government Fee for the Evaluation Process of Registration Application in Vietnam

Vietnam Ministry of Finance released Circular 59/2023/TT-BTC on 30 Aug 2023 pertaining to regulation on the collections, payment, management, and use of fees in the healthcare field. According to this regulation, the Government fee for the evaluation process of registration applications effective 16 Oct 2023 would be as follows: Class A: 1,000,000 VND Class B:

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Vietnam: New Draft Guidelines for Declaring Prices and Safety Inspection Procedures and Technical Features for Medical Devices in Vietnam

The Vietnam Ministry of Health is currently drafting a Circular to issue a list and provide guidelines for declaring the prices of medical devices. Simultaneously, the Ministry of Health has sent a letter requesting input from various organizations on the draft Circular regarding the list and guidelines for declaring prices of medical devices. In this

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Indonesia: Government Goods/Services Procurement Policy Agency (LKPP: Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah) issued an Announcement Letter about Brand Integration in e-Catalogue

On September 26, 2023, Government Goods/Services Procurement Policy Agency (LKPP: Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah) issued an Announcement Letter No. 26335/D.2.3/09/2023 pertaining Brand Integration in e-Catalogue with Directorate General of Intellectual Property (DJKI: Direktorat Jenderal Kekayaan Intelektual) Ministry of Law and Human Rights of the Republic of Indonesia. The highlights of the announcement are as

Indonesia: Government Goods/Services Procurement Policy Agency (LKPP: Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah) issued an Announcement Letter about Brand Integration in e-Catalogue Read More »

Philippines: Draft for Comments on the Recognition of Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services

The Philippines FDA is seeking comments from the stakeholders on the Draft Guidelines for the Recognition of Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services. All comments shall be sent as “.doxc” or “.pdf” to cdrrhr.rrd@fda.gov.ph or comment sheet may be accessed here. This guideline aims to recognize technical service providers for

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Singapore: HSA Published List of Standards for Medical Devices

Recognized standards are often used to demonstrate conformity to the Essential Principles of Safety and Performance of Medical Devices. On September 05, 2023, the Health Sciences Authority (HSA) of Singapore published a list of recognized standards for medical devices. This list matches the nationally recognized Singapore Standards (SS) against that of other Standard Development Organizations

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Singapore: HSA Safety Monitoring and GDPMDS Guidance Documents Update

HSA Safety Monitoring and GDPMDS Guidance Documents Update On September 08, 2023, the Health Sciences Authority (HSA) of Singapore published updates to related safety guidance documents as well as GDPMDS document, as follows: • GN-05: Guidance on Reporting of Adverse Events for Medical Devices Revision 3 • GN-07: Guidance on Complaint Handling of Medical Devices

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Thailand: Amendment on The Format of The Establishment Registration Certificate for Medical Device Manufacturers and Importers

The Thailand Food and Drug Administration (FDA) announced an amendment to the format of establishment registration certificate for medical device manufacturers and importers. This announcement was in line with the newly issued regulations dated 30 August 2023, as follows: Ministerial Regulation Establishing the Criteria, Procedures, and Conditions for the Registration of Medical Device Manufacturing B.E.

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Philippines: Pilot Implementation of Customer Relation Management Information System (CRMIS) by the Philippines FDA 

The Philippines FDA has issued Advisory No. 2023 – 1881 entitled “Pilot Implementation of the Food and Drug Administration Customer Relation Management Information System (CRMIS) which is an digital platform that will allow stakeholders and general public to submit inquiries, follow – ups, and other concerns via this link http://contact.fda.gov.ph/ Details of its implementation is

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Indonesia’s Government Issued a New Regulation Pertaining to Health

Indonesia’s government has officially issued Law No. 17 of 2023 concerning Health which comes into effect on 8 August 2023. At the time this new regulation came into force, the previous Law No. 36 of 2009 concerning Health was revoked and declared invalid. In general, Law No. 17 of 2023 covers the rights, obligations and

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Malaysia: MDA Released Guidance Document MDA/GD/0065: Placement of HIV Self-Test (HIVST) Kit in the Malaysian Market

In line with the issuance of Circular Letter No. 1 Year 2023 entitled “Permission for Placement in the Market of Human Immunodeficiency Virus (HIV) Disease Self-Test Kits,” the Medical Device Authority (MDA) of Malaysia has taken a crucial step by releasing the Guidance Document MDA/GD/0065 entitled “Placement of HIV Self-Test (HIVST) Kit in Malaysia Market”.

Malaysia: MDA Released Guidance Document MDA/GD/0065: Placement of HIV Self-Test (HIVST) Kit in the Malaysian Market Read More »

Malaysia: MDA released Circular Letter No. 1 Year 2023: Permission for HIV Self-Test Kits Placement in the Malaysian Market

The Ministry of Health (MoH) of Malaysia has initiated various efforts to combat HIV/AIDS infection in the country ever since the first detected case in 1986. One of which is by introducing an HIV self-testing (HIVST) as a pivotal method for Test and Treat HIV/AIDS. This initiative aims to encourage a larger segment of key

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Malaysia: Draft Regulation for Public Comments: Importation of Medical Device for Re-Export

The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled ‘Importation of Medical Device for Re-Export’ for public review and feedback. The key takeaways of this draft guidance document are as follows: 1. Scope: Applies to all products that fall within the definition of medical device, as defined in MDA/GD/0001: Definition

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Malaysia: Draft Regulation on ‘Wearable Medical Device’ for Public Comments

The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled “Wearable Medical Device” for public review and feedback. The key takeaways of this draft guidance document are as follows: Scope: To determine the wearable products that fall within the definition of medical device as stipulated in Section 2 of Medical Device

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Singapore: HSA Updated Medical Device Product Registration Guidance Documents and Related Templates

The Health Sciences Authority (HSA) of Singapore has revised guidance documents and templates pertaining to medical device product registrations. The key updates are as follows: Apart from requirements of registration under Health Products Act, local supply and use must comply with other legislations such as Private Hospitals and Medical Clinics Act, Healthcare Services Act, Professional

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Vietnam: Vietnam’s Ministry of Health and Ministry of Finance issues New Circular Regulations that benefits Medical Device Industry and Draft Regulation pertaining to exporting and importing MD with HS Code

The Ministry of Health of Vietnam issued several new regulations that took effect from July 1st, 2023. The following is the summary of how the regulations may have affected the provision of medical devices in the Vietnamese Market. Circular No. 14/2023/TT-BYT stipulated the order and procedures for formulating bidding packages for procurement of goods and

Vietnam: Vietnam’s Ministry of Health and Ministry of Finance issues New Circular Regulations that benefits Medical Device Industry and Draft Regulation pertaining to exporting and importing MD with HS Code Read More »

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