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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 At the time this new regulation came into force, the previous Law No. 36 of 2009 concerning Health was revoked and declared invalid.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”. …

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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The Medical Device Authority (MDA) of Malaysia has released a draft guidance document entitled ‘Importation of Medical Device for Re-Export’ for public review and feedback. The key takeaways of this draft guidance document are as follows: 1.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 …

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Singapore: Fifth Revision of Singapore’s Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices

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 …

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Malaysia: MDA Invites for Public Feedback on draft of First Edition Guidance Importation of Medical Device for Personal Use

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 …

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Indonesia: Ministry of Communication and Informatics (Kominfo) proposed changes on the standards for Telecommunication Equipment and/or Equipment Short Distance Telecommunications Devices

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 …

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Thailand: Thai FDA released a draft Ministry of Public Health Announcement on the Quality System to Produce Medical Devices B.E.

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 …

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Thailand: Thai FDA released a draft Ministerial Announcement on the Quality Management System for Importing or Selling Medical Devices, B.E.

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 …

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Indonesia’s Halal Regulation Update

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 …

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Indonesia: e-Catalogue Opening Submission for Maintenance and Repair Services for Healthcare Facilities

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 …

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Philippines: Draft Guidelines for Rules and Regulations for Establishment and Operation of Medical Magnetic Resonance Imaging (MRI) Facilities

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 …

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Indonesia: Ministry of Health issued Circular Letter for Medical Devices Post Market Testing

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, …

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Malaysia: MDA Released Third Edition Guidance Document on Medical Face Mask and Respirator (MDA/GD/0033)

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 …

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Singapore: Draft for Comments on GN-14: Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices Revision 3

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; …

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Malaysia: MDA Announced Transition Period for the Implementation of Electronic Medical Device Registration Certificate

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, …

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Philippines: Operating Periods of The Philippines FDA Online Services during System Maintenance and Upgrade

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 …

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Philippines: Food and Drug Administration (FDA) issues Guidelines on the Regulatory Flexibility for Class B, C and D Medical Devices not included in the Registrable List of Medical Devices

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 …

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Singapore: HSA has been recognized as a comparable overseas regulator for medical devices by the TGA

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) …

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Malaysia: MDA Announced Withdrawal of Incomplete Medical Device Registration (New and Re-Register) and Change Notification Application

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 …

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Malaysia: MDA Released Second Edition Guidance Documents for Product Classification

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). …

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Malaysia: MDA Issued Second Edition Guidance Document (MDA/GD/0061) Classification Of Rehabilitation, Physiotherapy and Speech Therapy Device

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 …

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Vietnam: Vietnam Government released Decree No. 07/2023/NĐ-CP amending and supplementing some articles of Decree No. 98/2021/NĐ-CP about medical device management

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 …

Vietnam: Vietnam Government released Decree No. 07/2023/NĐ-CP amending and supplementing some articles of Decree No. 98/2021/NĐ-CP about medical device management Read More »

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Singapore: Fifth Revision of GN-21: Guidance On Change Notification For Registered Medical Devices

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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Malaysia: MDA Issued the First Edition Guidelines on “Notification of Custom-Made Medical Device” (MDA/GD/0064)

On March 1st 2023, the MDA released the First Edition Guideline Document “Notification of Custom-Made Medical Devices” (MDA/GD/0064). This guidance document is intended to provide guidance for the requirements of custom-made medical devices that are eligible to be exempted under Medical Order 2016.   It also specifies the specific requirements and notification process to obtain permission …

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Philippines: Reiteration Against Unethical Business Practices Related To The Promotion Of Prescription Pharmaceutical Products And Medical Devices (PPPMD)

The Philippines Food and Drug Administration (FDA) issued an Advisory No. 2022-2045 on 29 December 2022, to warn all Prescription Pharmaceutical Products and Medical Devices (PPPMD) companies, and healthcare professionals (HCPs) not to engage in unethical business practices as mentioned in the provisions of Administrative Order (AO) No. 2015-0053 entitled “Implementing Guidelines on the Promotion …

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