Kia UP

Admin folder for amendments

MDA Issued Fourth Edition Guidance Document “Change Notification for Registered Medical Device” (MDA/GD/0020)

On November 21, 2022, the MDA has announced the release of the Fourth Edition Guidance Document “Change Notification for Registered Medical Device” (MDA/GD/0020). This guidance document is a revision from the Third Edition that was issued in November 2018, to provide the medical device industry a guidance on the categories of changes, the principles of …

MDA Issued Fourth Edition Guidance Document “Change Notification for Registered Medical Device” (MDA/GD/0020) Read More »

Barcode labels on rolls

MDA Issued Sixth Edition Guidance Document “Requirements for Labelling of Medical Devices” (MDA/GD/0026)

On November 21, 2022, the MDA has announced the release of the Sixth Edition Guidance Document “Requirements for Labelling of Medical Devices” (MDA/GD/0026). This guidance document provides minor updates from the Fifth Edition that was issued on 14 June 2022. This document provides guidance to the manufacturers and authorized representatives on the content of medical …

MDA Issued Sixth Edition Guidance Document “Requirements for Labelling of Medical Devices” (MDA/GD/0026) Read More »

Clinical trial injection bottle and hypodermic needle

GN-20: Guidance on Clinical Evaluation Revision 2

The Health Sciences Authority (HSA) Singapore published minor update of guidance document entitled GN-20 R2 Guidance on Clinical Evaluation on 01 November 2022, stipulating clinical investigations carried out by or on behalf of product owner are encouraged and expected to be designed, conducted, and reported in accordance with international ISO 14155 – Clinical Investigation of Medical Devices for …

GN-20: Guidance on Clinical Evaluation Revision 2 Read More »

A shelf of manilla files

Notification of the Ministry of Public Health RE: Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565 2022

The Medical Device Control Division, Thai FDA of the Ministry of Public Health has issued Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565, effective 03 December 2022, repealing The Notification of the Ministry of Public Health RE: Classification of Notification Medical Device (Class B and Class C) B.E. 2563 …

Notification of the Ministry of Public Health RE: Classification of Notification Medical Device (Class B and Class C) No. 3 B.E. 2565 2022 Read More »

Updates

Minor Update on GN-06: Guidance on Distribution Records

In line with GDPMDS, HSA Singapore also published minor updates of guidance document entitled GN-06 R3 Guidance on Distribution Records on 01 Nov 2022 which assist product owners on the determination of projected useful life of the medical device. Projected useful life of a medical device is dependent on various factors such as technical, legal, …

Minor Update on GN-06: Guidance on Distribution Records Read More »

New certification

GN-33: Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices

Health Sciences Authority (HSA) Singapore has reviewed and validated the medical device guidance document entitled GN-33 R1.2 Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices Revision 1.2 on 01 Nov 2022 to ensure its accuracy. This guidance document serves to provide advice for application of SS 620: 2016 Singapore Standard …

GN-33: Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices Read More »

Minor update

Minor Update on HSA Guidance on Labelling for Medical Devices

The Health Sciences Authority (HSA) Singapore published a minor update to guidance document, GN-32: GUIDANCE on Labelling for Medical Devices Rev 2 (dated September 2022). This update provides alignment to GN-36: Guidance on Medical Device Unique Device Identification (UDI) System mandating the UDI compliance for medical devices in Singapore. The followings are the added points …

Minor Update on HSA Guidance on Labelling for Medical Devices Read More »

Person carrying out audit and checking paperwork application

Procedures For Receiving, Appraising, Issuing, Post-Inspection, And Withdrawing The Circulation Number Of The Medical Devices

On 12 September 2022, the Vietnamese Ministry of Health issued the QT.TBCT.15 entitled “Procedures for Receiving, Appraising, Issuing, Post-Inspection, and Withdrawing the Circulation Number of The Medical Devices. The regulation applies to the evaluation of all registration routes of medical devices class C and D, and its post inspection with the case of fast-track and …

Procedures For Receiving, Appraising, Issuing, Post-Inspection, And Withdrawing The Circulation Number Of The Medical Devices Read More »

Person using touchscreen app

Guideline for Re-Registration of Registered Medical Device by MDA

On September 15 2022, the MDA has issued second edition of guideline document entitled “Re-Registration of Registered Medical Device” (MDA/GL/08). The following information are added on the guideline: Applicant is not allowed to submit re-registration application concurrently with change notification application; and Requirements on Pre-Market Clearance / Approval All application shall undergo conformity assessment via …

Guideline for Re-Registration of Registered Medical Device by MDA Read More »

Person completing forms and admin with a hot drink

Philippines FDA Issued FDA Circular 2022-008: Guidelines For The Abridged Processing Of Application For Registration Of Medical Devices Approved By The National Regulatory Authority Of Any ASEAN Member Country

On 27 September 2022, the Philippines FDA issued FDA Circular No. 2022-008 which aims to provide guidelines on the abridged processing of application for registration of medical devices with product approval issued by the NRA of any ASEAN member country under the AMDD-CSDT requirements. This Circular shall apply to Class B, C and D medical …

Philippines FDA Issued FDA Circular 2022-008: Guidelines For The Abridged Processing Of Application For Registration Of Medical Devices Approved By The National Regulatory Authority Of Any ASEAN Member Country Read More »

Scroll to Top