The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled ‘Importation of Medical Device for Re-Export’ for public review and feedback. The key takeaways of this draft guidance document are as follows: 1.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 […]
The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled “Wearable Medical Device” for public review and feedback. The key takeaways of this draft guidance document are as follows: Scope: To determine the wearable products that fall within the definition of medical device as stipulated in Section 2 of Medical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
Malaysia: Draft Regulation on ‘Wearable Medical Device’ for Public Comments Read More »
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
The medical devices market in Malaysia is poised for significant growth, driven by advancements in healthcare infrastructure and increasing healthcare expenditure. With a projected revenue of US$3.27 billion in 2023, the industry is witnessing a dynamic shift, attracting attention from both local and international players. Cardiology Devices Leading the Market Among the various segments within
Malaysia’s Medical Devices Market: US$3.27B Projected Revenue in 2023! Read More »
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
The Health Sciences Authority of Singapore (HSA) has revised the GN-02: Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices as of 31 July 2023. This guidance will be applicable to any entity who performs manufacturing, importing, and supplying by wholesale of the medical devices. The following are the highlights of the guidance
Medical Device Authority (MDA) has released a draft guidance document titled ‘Importation of Medical Device for Personal Use’ for public review and feedback. The guidance document will be applicable to all home use medical devices that fall within the definition of a medical device, as defined in MDA/GD/0006: Definition of Medical Device, including in vitro
On 13 July 2023, The Ministry of Communication and Informatics (Kominfo) issued a draft regulation concerning Technical Standards for Telecommunication Equipment and/or Equipment Short Distance Telecommunications Devices. The proposed guidelines will revoke several regulations including SDPPI regulation no 161 Year 2019, the main reference in the registration of Short-Range Devices (SRD). This SRD technologies includes
In the interest of consumer protection and to ensure the quality, efficiency, and safety of medical device production, the Thai FDA released a draft public health announcement and guideline to establish a quality system for producing medical devices on 19 July 2023. Should the final announcement and guideline be approved and released, effectivity would be
In the interest of consumer protection and to ensure the standardized quality, efficiency, and safety of importing or selling medical devices, the Thai FDA released a draft announcement and guideline on the Quality Management Systems for Importing and Selling Medical Devices on 19 July 2023. Should the final announcement/guideline be approved and released, effectivity would
On 27 June 2023, the Ministry of Health (MoH) of Indonesia invited relevant stakeholders to gather input on the Draft Guidelines for Halal Manufacturing Practices for Drugs, Biological Products, and Medical Devices, as well as the Inclusion of Information on the Origin of Ingredients for Medical Devices. Andaman Medical Indonesia was amongst those who were
On 20 July 2023, the Ministry of Health (MoH) Indonesia invited stakeholders to a Socialization of e-Catalogue Opening Submission for Maintenance and Repair Services for Healthcare Facilities via Zoom meeting. Indonesia MoH Bureau of Procurement of Goods and Services announced the opening submission for maintenance and repair services for Healthcare Facilities and share the requirements
The Food and Drug Administration (FDA) Philippines has issued draft guidelines to specify the requirements on the use and operation of facilities utilizing Magnetic Resonance Imaging (MRI). In the draft guidelines, all MRI facilities would be required to secure an authorization from FDA through the current rules and regulations on the licensing and registration of
On July 21, 2023, the Ministry of Health (MoH) issued Circular Letter HK.02.02/E/1289/2023 pertaining to Medical Devices Post Market Testing. In the framework of implementing Government Regulation of the Republic of Indonesia Number 5 Year 2021 (Implementation of Risk-Based Business Licensing), and to ensure that medical device products in circulation meets the requirements of safety,
On July 14, 2023, the Medical Device Authority of Malaysia (MDA) announced a transition period of registration with exemption from compliance assessment process by the Compliance Assessment Body (CAB) for the registration of COVID-19 test kits based on Circular Letter Number 2/014. In accordance with Number Circular 2/2014, the evaluation of the COVID-19 test kit
The Medical Device Authority of Malaysia (MDA) announced the use of expired EC Certificates for new registration and re-registration of medical devices under certain conditions. This new approach was made due to unpredictable timeline and issues in relation to the transition to the EU MDR and to ensure a continuous supply of medical devices in
The Medical Device Authority of Malaysia (MDA) withdrawn the guidance document MDA/GD/0059 for COVID-19 RTK (SELF – TEST) – REQUIREMENTS from the MDA website on June 8, 2023. The guidance document was initially established and published with the intention to give specific requirements for conditional approval of Covid-19 RTK (self-test) to be placed in the
The Health Sciences Authority (HSA) of Singapore has been recognized by the World Health Organization (WHO) as a WHO Stringent Regulatory Authority (SRA) for high-risk (Class C and D) in vitro diagnostic medical devices (IVDs). The HSA joins the five founding members (European Union, The United States, Canada, Australia, and Japan) of Global Harmonisation Task
The Medical Device Authority of Malaysia (MDA) announced that enhancements have been made to the MeDC@St 2.0+. For notification module, an improved features have been added to the Clinical Research Use sub-module as follows: The online form has a new look and allows batch uploads on medical device listings. Print Application that allows printing of
The Medical Device Authority (MDA) released the Third Edition Guidance Document of Medical Face Mask and Respirator (MDA/GD/0033) on May 19, 2023. This guideline was intended to provide clarification on medical face masks and respirators regulated under the Section 2 of Medical Device Act (Act 737) and is applicable to establishments, healthcare facilities, and public
The Health Sciences Authority of Singapore (HSA) is soliciting the industry’s feedback on the Draft Guidance Document: GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices Revision 3. Updates in the Draft Guidance Document includes: Inclusion of Standalone software (SaMD) definition per IMDRF; Clarifications on the classification of control materials and software;
Starting May 2, 2023, the Medical Device Authority of Malaysia (MDA) will implement the use of ‘Electronic Medical Device Registration Certificate’. This electronic medical device registration certificate can be downloaded from the MeDC@St2.0+ system once the application status is deemed as complete. A transition period up until December 31, 2023, is given to the establishment,
The Philippines Food and Drug Administration (FDA) issued an advisory to inform that they will not be accepting any online applications for any services, except for applications for Compassionate Special Permit (CSP) and Certificate for Customs Release (CFCR), during their system maintenance and upgrade period. Starting 05 April 2023, all FDA online services shall only
In consideration of the challenges brought about by the full implementation of AO 2018-002, the FDA recognizes that there is a need to provide medical device companies more time to prepare the technical documentary requirements based on the ASEAN Common submission dossier template (CSDT) in applying for CMDR. With this, the Philippines FDA issued the
As released on the HSA NEX2US Issue 09 Newsletter (March 2023), Australia’s Therapeutic Goods Administration (TGA) recognized The Health Sciences Authority of Singapore (HSA) as a Comparable Overseas Regulator (COR) with comparable system for the evaluation of medical devices from September 2022. This recognition enables HSA to join the ranks of the other 4 (four)
On March 23rd 2023, the MDA announced that they will withdraw the medical device registration (new and re-register) application and change notification application that has not been completed within 30 working days, starting from 1st April 2023. A transitional period will be given to the applicant until May 1st for the full implementation on withdrawal
On February 2023, Malaysia’s Medical Device Authority (MDA) released a guidance document for the requirements of Product Classification. This guidance document is a revised version of MDA/GL/06 that was released in October 2021,that provides guidance, reference, and clarification on how to apply for Product Classification that are regulated under the Medical Device Act (Act 737).
Malaysia: MDA Released Second Edition Guidance Documents for Product Classification Read More »
On March 9 2023, the MDA has announced the release of the Second Edition Guidance Document “Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device” (MDA/GD/0061). This guidance document was prepared by the Medical Device Authority (MDA) to provide the classification of a list of products used for rehabilitation, physiotherapy, and speech therapy by determining whether
On 03 Mar 2023, the Vietnam Government signed and released Decree No. 07/2023/NĐ-CP amending and supplementing some articles of Decree No. 98/2021/NĐ-CP about medical device management, which takes effect immediately. Some of the key highlights are mentioned below: Management of medical device prices Listing of prices of medical devices Organizations and individuals manufacturing and trading
FIFTH REVISION OF GN-21: GUIDANCE ON CHANGE NOTIFICATION FOR REGISTERED MEDICAL DEVICES The Health Sciences Authority (HSA) of Singapore issued a fifth revision of GN-21: Guidance on Change Notification for Registered Medical Devices. This new revised guidance has been made effective starting March 07th 2023. With this revised guidance, it is informed that the Safety
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