Knowledge of response times, requirements that must be met, trademarks and samples is crucial for obtaining sanitary registration of...

The original guidance from the US Food and Drug Administration (FDA) on the biological evaluation of medical devices was The Blue Book...

Medical devices distributed in Japan are subject to the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices,...

Asia: Raft of guidance documents endorsed at 21st Annual Meeting of the AHWP Australia: Regulatory reform consultations Australia: MTAA...

Europe: Latest timings on the new Regulations for medical devices and IVDs Europe: Products whose principal intended action (depending on...

Canada: Non-eCTD electronic-only format to be used for medical device regulatory activities Canada: Scientific and clinical content of...

Argentina: Aesthetic use products to be subject to sanitary registration requirements Brazil: Clinical data requirements for innovative...

Australia: Strengthening Monitoring of Medicines in Australia Canada: Notice: Guidance Document - Fees for the Right to Sell Drugs...

The proposed regulatory guidelines for telehealth devices by the Health Sciences Authority (HSA) for public consultation has been closed...

In late October 2016, ARQon meeting with CFDA on the exchange sharing of fast track authorization route in Singapore and the Green...

Latest China FDA announcement on the Second Batch of Medical Device Exempted from Clinical Investigation CFDA latest announcement on 30...

Vietnam's Decree on Management of Medical Devices (No. 36/2016/ND-CP) is coming soon - probably sooner than expected for the unprepared....

The Health Sciences Authority of Singapore (HSA) introduced the Health Products Act (HPA) in 2007 in which their aim is to consolidate...

The Singapore Quality Overall Summary (SQOS) was introduced in 2007 to provide information specific to product registration in Singapore....

The FDA recently released two draft guidance documents: "Deciding When to Submit a 510(k) for a Change to an Existing Device,” which...

Currently only some certain medical devices are registrable. From 1 July 2017, Class B, C, and D medical devices are required to be...

According to the Saudi FDA, full compliance with GS1 data carriers on pharmaceutical products is required by March 2017. This includes...

Malaysia Device Authority of Malaysia (MDA) just recently published the medical device guidance document on the requirements for...

A recent announcement by the Therapeutic Goods Administration Australia (TGA) provides information for current users of ISO 13485:2003...

The precise impact of a vote for Brexit is currently still uncertain. It would fundamentally change the nature of the UK’s relationship...