Medical Device Authority (MDA) has published a guidance document ‘PLACEMENT OF HIV SELF-TEST (HIVST) KIT IN MALAYSIA MARKET” for public comment. This document is written to guide the establishment on both pre-market, placement on the market, and post-market requirements including requirements on registration of HIVST, licensing of establishments dealing with HIVST, product labeling, advertising and distribution, […]
Guidance on the Product Grouping for In-Vitro Diagnostic (IVD) Medical Devices. MDA/GD/0054 December 2020 Second Edition Medical Device Authority (MDA) had released a new guidance for upcoming and existing Conformity Assessment Body in their pursuit to comply with the Medical Device Act (Act 737) and the regulations under it. This updated document is written in […]
PENGIKLANAN DAN PENJUALAN PERANTI PERUBATAN YANG DIDAKWA SEBAGAI KIT UJIAN KENDIRI COVID-19 (COVID-19 SELF TEST KIT) (ADVERTISING AND SALE OF MEDICAL DEVICES CLAIMED AS COVID-19 SELF TEST KIT ) Pihak Berkuasa Peranti Perubatan (MDA) telah menerima pelbagai aduan dan mendapati ada pihak-pihak yang menjalankan aktiviti pengiklanan dan penjualan kit ujian yang didakwa sebagai kit ujian kendiri […]
PENJUALAN PERANTI PERUBATAN MELALUI PLATFORM E-DAGANG (SALE OF MEDICAL DEVICES THROUGH E-COMMERCE PLATFORM) Pihak Berkuasa Peranti Perubatan (PBPP) telah menerima pelbagai pertanyaan dan aduan berkaitan penjualan peranti perubatan tidak berdaftar di platform e-dagang. PBPP ingin menegaskan mana-mana pengedar dan penjual yang hendak menjual dan mengiklankan peranti perubatan di platform e-dagang hendaklah mematuhi semua keperluan pendaftaran, pelesenan […]
CHECK OUT OUR UPDATED SERVICES! We would like to take this opportunity to share with you some new info about our services in GDSB which may be of assistance to your company: a) Quality Management System – ISO 13485 b) Good Distribution Practice for Medical Devices (GDPMD) c) Conformity Assessment by Way of Verificationd) Conformity […]
Please be informed that the PBPP Search System known as Public Search – Malaysia Medical Device Register (MMDR), URL Address: www.mmdr.mda.gov.my has been amended with the name of the new system and URL address namely MEDICAL DEVICE AUTHORITY REGISTER (MDAR), Address URL: https://mdar.mda.gov.my Currently, the search results view only involves licensed establishment data and registered […]
Medical Device Authority (MDA) had released a new guidance for upcoming and existing Conformity Assessment Body in their pursuit to comply with the Medical Device Act (Act 737) and the regulations under it. This updated document is written in conjunction with the current laws and regulations used in this country which include but not limited […]
(1) All medical device shall be: appropriately classified in accordance with the classification rules as specified in FIRST SCHEDULE; and appropriately grouped using the rules of grouping as specified in SECOND SCHEDULE. (2) In the event of any dispute between the establishment and a conformity assessment body over a classification of a medical device, the […]
Any Medical Device placed in the market need to register with Medical Device Authority Malaysia. According to Medical Device Act 2012, Part III, Licence and Permit, Chapter 1, Establishment licence. 16. APPLICATION FOR ESTABLISHMENT LICENCE (1) An establishment may apply for an establishment licence to be granted under this Act by submitting a written application […]
