Regulatory updates Archives

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

August 8, 2023

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

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

August 7, 2023

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

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

August 7, 2023

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

Indonesia’s Halal Regulation Update

August 2, 2023

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

Enterprise resource planning(ERP) and management documentation concept. Businesswoman working on a laptop with virtual digital screen icons.

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

August 2, 2023

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

Patient visiting MRI procedure in a hospital

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

July 27, 2023

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

Regulatory Updates

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

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

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

Indonesia’s Halal Regulation Update

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

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

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