TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Australia – TGA advises on 3D-printed device risks

Three dimensional (3-D) printing (an additive manufacturing process), is a process where computer-aided-design (CAD) software or a 3-D scanner is used to develop an...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – Govt releases guidelines for schemes to boost domestic manufacturing of bulk drugs,...

The government on Monday released guidelines for four schemes to boost domestic manufacturing of bulk drugs and medical devices as part of its drive...
TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Australia – Delays to the commencement of certain medical device regulatory changes

The Governor-General in Council has made regulations which delay the commencement of a number of medical device reforms in Australia. This delay reflects the...

Australia – Actual and potential harm caused by medical software

The advent of widespread software resources, particularly those accessible through smart phones and smartphone apps has led to public expectations that digital health and...
Malaysia’s MDA Posts Draft Guidance on Importing Devices for Re-Export

Malaysia – Malaysia’s MDA publishes post-market surveillance guidance documents

Over the last two months, Malaysia’s Medical Device Authority (MDA) has issued three noteworthy guidance documents relating to post-market surveillance. These expand on the...
TGA suspends overseas GMP inspections and QMS audits until further notice

Australia – TGA releases new fee schedule and announces reform delays

Australia’s Therapeutic Goods Administration (TGA) published its new fee schedule for the upcoming year and announced delays to a series of regulatory reforms. 2020-21 fee...
China’s NMPA Launches Voluntary Device Master File Process

China – New procedures released for medical device registration in China

China’s Center for Medical Device Evaluation (CMDE) issued two announcements recently outlining revised procedures relating to medical device registration. Increased standardization of filing review process CMDE Announcement...

Australia – Proposed delayed commencement of certain medical device regulatory changes

Reflecting the challenges identified by the medical devices industry and healthcare professionals as they have focussed on the COVID-19 crisis, the Australian Government intends...
Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – South Korea adds renewal requirement for new medical device authorizations

MFDS issues significant revision to Medical Devices Act South Korea’s Ministry of Food and Drug Safety (MFDS) published a revision to Article 49 of the...
TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Australia – Post-market evaluation of serology-based point of care tests

In response to the COVID-19 pandemic, the Therapeutic Goods Administration (TGA) has expedited the approval (with conditions) of COVID-19 tests including tests intended for...

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