The National Public Procurement Agency, which is responsible for managing the government's “e-Katalog”, issued provision No. 122/2022 concerning the Procedures for Organizing Electronic Catalogues. This changed the previous “e-Katalog” mechanisms including MoH's Sectoral E-Katalog.
More NMPA has organized and revised the “Guidelines for the Compilation of the Annual Self-Inspection Report of Medical Device Quality Management System”, which has been promulgated and shall come into force on May 1, 2022. The Guidelines for the Compiling of the Annual Self-Inspection Report of Quality Management System of Medical Device Manufacturers issued by NMPA (No. 76 of 2016) previously shall be abolished at the same time.
More NMPA has released a series of updated guidelines, which aim to guide registration applicants to prepare for medical device software and AI medical device registration in China. The 3 new guidelines regulate the technical reviewing requirements of medical device software and AI medical devices, while also elaborating on standardizing the cyber-security for medical devices.
More Starting from February 2022, the Indonesia Ministry of Health is accepting product listing of medical devices and other health equipment for their sectoral e-catalogue for health facilities.
More This guideline applies to medical devices including in vitro diagnostic reagents applying for registration or filing with NMPA in China. This guideline only provides general requirements for the format and content of the product technical requirements (PTR) for medical devices and does not specify specific requirements for certain products.
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As Qualtech offers Authorized Representative (License Holder) Services in 11 countries in Asia and Oceania, the following article outlines some of the benefits for foreign manufacturers associated with assigning a neutral 3rd party as their license holder. In addition, the product registration license conditions for the different ASEAN countries, as well as Taiwan, Japan, Hong Kong, Australia, and China are summarized, including license validity, license transfer possibilities etc.
More Since January 18th, 2022, FDA formally classified the electrocardiograph software for over-the-counter use as class II (special controls).
More Indonesia Halal Product Assurance Agency (BPJPH) has announced fix service rates related to Halal Certification according to the Decree of Head of BPJPH Regulation Number 141 of 2021, which have been implemented since 1st December 2021.
More MDA now recognizes MHRA, UK is now an additional recognized foreign regulatory agency by the MDA and its approval type for Great Britain and Northern Ireland can be used for medical devices to undergo a simplified registration route (by conformity assessment) in Malaysia.
More In light of the ongoing pandemic situation, MDA has granted conditional approval to establishments intending to supply COVID-19 self-test kits in Malaysia. A detailed guidance document is published on this, intending to provide establishments with information about the requirements for distributing Covid-19 RTK (self-test) in the market. This guidance document does not apply to Covid-19 test kits for professional use only.
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