South East Asia Medical Device Registration Archives -

Public Consultation on a Medical Device Cybersecurity Labeling System

This article deals with the public consultation for the cybersecurity labeling scheme for medical devices. Medical equipment is increasingly being linked to hospital and home networks in order to improve patient care. However, this connectivity expands the attack surface for […]

New Guidelines Implemented by the Philippines FDA

|Posted In: Medical , Medical Device , medical device , Medical Device Registration , News , philippines , South East Asia Medical Device Registration

This article deals with the Guidelines on the Food and Drug Administration’s Regulatory Actions during Declared National or State Public Health Emergencies which are being implemented. The FDA is the authorized agent for Medical Device registration in Philippines. This ensures […]

Apply for registration of a Refurbished Medical Device, Malaysia

|Posted In: Medical , Medical Device , medical device , Medical Device Registration , News , South East Asia Medical Device Registration

This Article Deals about the Submission of Medical Device Application for Registration Published by Medical Device Authority of Malaysia. This manual was created to help the manufacturer and Authorized representative while registering a used medical equipment. A medical device must […]

Medical Device Approval by Ministry of Public Health, Thailand

|Posted In: Medical , medical device , Medical Device , News , South East Asia Medical Device Registration , Thailand

This Article deals with the Prescription for some Medical Device advertisements that don’t need medical device approval which is published by the Thailand Government. There are numerous regulations for medical device advertising that are intended to allow business owners to […]

Medical Device Registration Authority Subscription, Malaysia

|Posted In: Dental , Import License , Medical , Medical Device , medical device , Medical Device Registration , News , South East Asia Medical Device Registration

This Article deals with the Medical Device Registration in Malaysia. The Medical Device Registration Authority of Malaysia (MDA), also known as Medical Device Authority-Regulatory Information Subscription, released a notice on how to stay up to date with the MDA for […]

New Medical Device Registration Applications in Philippines

|Posted In: medical device , Medical Device Registration , News , South East Asia Medical Device Registration

This Article deals with the New Medical Device Registration policy of the Philippines, Published by Food and Drug Administration on 27 September 2022. The latest Circular, provides guidelines on the abridged processing of medical device applications for registration with product […]

Introduction to Medical Device Registration in Korea

|Posted In: Blog , Blog Morulaa , Dental , Medical , medical device , Medical Device , Medical Device Registration , South East Asia Medical Device Registration | 0

Introduction to Medical Device Registration in Korea This article deals with the Medical Device Registration in Korea. South Korea ranks fourth among countries in the Asia-Pacific region’s healthcare market. The increase in the aging population, and the insurance coverage, along […]

Medical Devices Registration in Philippines

|Posted In: Blog , Blog Morulaa , Medical , Medical Device , Medical Device Registration , philippines , South East Asia Medical Device Registration | 0

Introduction – Medical Devices Registration in Philippines This article deals with the Medical Devices Registration in Philippines. The Philippines’ Food and Drug Administration (FDA), which functions under the Department of Health, issues the license, monitors, and regulates the flow of […]

Medical Device Registration in Malaysia

|Posted In: Blog , Blog Morulaa , Dental , Medical , Medical Device , medical device , Medical Device Registration , South East Asia Medical Device Registration | 0

Introduction to Medical Device Registration in Malaysia This article deals with the Medical Device Registration in Malaysia. Malaysia is one of the most robust and dynamic markets for foreign medical device manufacturers as the government is supporting medical tourism. Due […]

Introduction to Medical Device Registration in Indonesia

|Posted In: Blog , Blog Morulaa , Dental , Indonesia , Indonesia MOH RI , Medical , medical device , Medical Device , Medical Device Registration , South East Asia Medical Device Registration | 0

Introduction to Medical Device Registration in Indonesia This article deals with the Medical Device Registration in Indonesia. The Ministry of Health Republic of Indonesia (MOH RI) is the authority to issue the Certificate for the Medical Devices. Regulation of Medical […]

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South East Asia Medical Device Registration