New Medical Device Act Recently, Thailand FDA has just announced new Medical Device Act (more information will be given in an update...

PP JPH has been signed by the President on 29 April 2019 and promulgated on 3 May 2019. However, the PP copy has not yet been published,...

Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices On 12 April, the...

On 12 Apr 2019, the US FDA published the "Finalized List of Accessories Suitable for Class I" medical devices document, as required by...

The International Medical Device Regulators Forum (IMDRF) is a forum for regulators to discuss directions in medical device regulatory...

Below are the news related to Drug Regulatory Authority of Pakistan (DRAP). For registration of drugs in Pakistan, DRAP has made it...

On March 1st, 2019, ANVISA published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with the migration of...

Australia: Reclassification of surgical mesh devices and publication of associated guidance Australia: Proposed fees and charges for...

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...