Regulatory updates Archives

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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

April 6, 2023

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,

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

March 28, 2023

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

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

March 27, 2023

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

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Malaysia: MDA Released Second Edition Guidance Documents for Product Classification

March 27, 2023

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

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

March 24, 2023

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

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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

March 21, 2023

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

Regulatory Updates

Regulatory Updates

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

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

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

Malaysia: MDA Released Second Edition Guidance Documents for Product Classification

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

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

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Regulatory Updates

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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

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

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

Malaysia: MDA Released Second Edition Guidance Documents for Product Classification

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

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

Countries

Categories

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Main Pages

Address

E-mail Address

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