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 […]
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:
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
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
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
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
Singapore: HSA Published List of Standards for Medical Devices Read More »
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
Singapore: HSA Safety Monitoring and GDPMDS Guidance Documents Update Read More »
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.
Medical devices in Cambodia are regulated by the Department of Drugs and Food (DDF) under the Ministry of Health. The main legislation that specifically regulates medical devices is Prakas No. 1258 (8 November 2012) on the Procedures for the Registration of Medical Devices (hereafter as ‘Prakas 1258’). Prakas is a Cambodian term which means official
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
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
Indonesia’s Government Issued a New Regulation Pertaining to Health Read More »
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”.
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
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
