EU: More advisory documents issued to support implementation of MDR and IVDR EU: Manual on borderline and classification issues updated...

Canada: Non-compliant device labels may now be relabelled/corrected after importation Canada: Priority review process for device...

Brazil: Electronic submission of application documentation to replace paper copies Brazil: Proposal for ‘classifying’ medical devices as...

IMDRF: Optimising standards; Essential Principles; personalised medical devices ISO: Third edition of ISO 14155 on clinical...

Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...

On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance setting out the...

Berg Insight analysed the latest developments on the telehealth and telecare markets in the Europe region. The study provides 165 pages...

Singapore Health Sciences Authority (HSA) shared the following updates on 28 March 2019: Update to the GN21 Change Notification (CN)...

Online Medical Device Classification Guideline MOH Indonesia provides online classification guideline to help applicant to define the...

Listing of LRP Hong Kong's Medical Device Control Office (MDCO) has plans to issue new Guidance Notes on the Listing of Local Responsible...

In December 2018, China's National Medical Products Administration (NMPA) released the Special Medical Device Special Review Procedure...

The US FDA released a statement on the topic of materials used in medical devices as part of their effort to address potential safety...

The exit of the United Kingdom (UK) from the European Union (EU) will cause implications to the medical industry in Australia....

The Association of Southeast Asian Nations (ASEAN) have published the following two documents under the section of Harmonisation of...

India's Ministry of Health and Family Welfare published a new gazette notification on 15 Jan 2019, regarding an amendment to the Medical...

Executive Summary: The latest Asian Medtech Associations Regulatory Networking discussions extended to news from Malaysia, Vietnam,...

Executive Summary: The January 2019 Asian Medtech Associations Regulatory Networking discussions focus on the volume of activity within...

The Info-communications Media Development Authority (IMDA) issued "Connected Medical Device Security" Technical Reference in end 2018....

Taiwan FDA is currently seeking public feedback on three new regulations in cosmetic products. The Authority proposing draft Regulations...

Both the Council Directive 93/42/EEC (MDD) and Council Directive 90/385/EEC (AIMDD) will transition into the Medical Device Regulations...