April 2021

new vietnam medical device regulations proposed

New Vietnam Medical Device Regulations Proposed

The Vietnamese Ministry of Health (MoH) has published a draft decree which is intended to replace Decree No. 36/2016/ND-CP​ and its amendments, which currently form the legal framework for regulating medical devices in Vietnam. The draft was released as Official Dispatch No. 2271/BYT-TB-CT on 31 March 2021. In order to unify Vietnam’s medical device regulations …

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fda registration philippines class a medical devices list

Philippines FDA consults industry on Class A Medical Devices List

The Philippines Food and Drug Administration (FDA) recently released a draft for comments on the List of Class A Medical Devices for FDA registration in the Philippines. The List of Class A Medical Devices helps medical device industry stakeholders to determine the appropriate risk classification of their device in order to apply for the correct …

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hsa singapore medical device registration

Singapore’s HSA Medical Device Grouping Tool

Singapore’s Health Sciences Authority (HSA) has recently launched an interactive self-help tool to guide the grouping of medical devices.  Certain medical devices may be grouped together in one application to facilitate medical device registration in Singapore. The chief feature of this tool is its interactive Q&A format. The platform guides you through a series of …

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in vitro diagnostic medical device

In-vitro diagnostic medical device product grouping in Malaysia

The Medical Device Authority (MDA) in Malaysia released the second edition of a guidance document on In Vitro Diagnostic Medical Device Product Grouping (MDA/GD/0054). IVD devices are regulated medical devices in Malaysia. IVD devices can include, for example, reagents, calibrators, sample collection and storage devices, control materials and related instruments or apparatus. The information provided …

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indonesia mandatory validation testing for covid19 rapid antigen kits

Indonesia mandatory testing for Covid-19 Antigen Rapid Diagnostic Tests

Indonesia’s Ministry of Health issued an announcement on 22 April 2021 concerning validation testing of Covid-19 Antigen Rapid Diagnostic Tests. In order to improve the safety, quality and efficacy of Covid-19 Antigen Rapid Diagnostic Testing (RDT-Ag) products, it is now mandatory to submit validation test results from at least 1 (one) Testing Laboratory. This applies …

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philippines fda updates process covid 19 test kit application

Philippines FDA updates process for COVID-19 test kit applications

The Philippines Food and Drug Administration (FDA) has issued Advisory No.2021-0684: “Guidelines on the process of the issuance of Special Certification of COVID-19 Test Kits” which updates the process of applying for a Special Certification of COVID-19 test kits. In essence, applications for Special Certification for COVID-19 Test Kits, require manufacturers to comply with the …

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addendum to philippines fda circular 2021 0002 guidelines on applications for medical device authorizations

Philippines FDA requests comments on transition period for new medical device registration rules

The Philippines Food and Drug Administration (FDA) recently released a draft for comments on an Addendum to FDA Circular 2021-002: Full implementation of FDA Administrative Order No. 2018-00021. FDA Circular 2021-0002 introduced the guidelines for the filing of applications and issuances of Certificates of Medical Device Notification (CMDN) and Certificates of Medical Device Registration (CMDR) …

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Medical device advertising approval Malaysia

Medical device advertising approval in Malaysia

The Malaysian Medical Device Authority (MDA) has recently published the first edition of a guide listing the requirements for applying to obtain approval for medical device advertisements from the MDA entitled “Application for medical device advertisements approval – requirements” (MDA/GL/04). This document provides an overview of the application procedure for medical device manufacturers, distributors and …

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indonesia halal certification andaman medical insights

Indonesia Halal Certification 2021 – new regulations

The implications of the halal certification process for medical devices incorporating animal products in Indonesia Catering to Indonesia’s growing need for halal products Indonesia accounts for the largest Muslim population worldwide. With approximately 225 million Muslims, there is an increasing demand for Halal products. In response to this growing need, the Government aims to establish …

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indonesia e catalogue technical stage extension

Indonesia extends E-Catalogue negotiation stage

Indonesia’s National Public Procurement Agency (NPPA = LKPP) has extended the Technical Verification and Negotiation stage until Monday 19th April 2021. It had already been extended to 26th March. To avoid missing out on future calls for tender to supply the national healthcare system in Indonesia (which is only possible via the e-Catalogue), register your …

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