Regulatory Policy Archives - NS Medical Devices

20 Mar 23

Company Must Stop Marketing Unauthorized Products

FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette Products

Click Therapeutics’ CT-132 gets FDA breakthrough status in episodic migraine

DevicesRegulationRegulatory Policy

19 Dec 22

Presently under development, the CT-132 digital therapeutic candidate has secured the FDA designation in patients of age 18…

European Commission blocks Illumina’s $8bn acquisition of GRAIL

DevicesRegulatory PolicyDiagnostic Devices

07 Sep 22

Illumina announced that it is reviewing the EC's order on blocking the deal, while revealing its intention to…

FDA and ECRI Partner on Materials Safety in Medical Devices

01 Oct 21

ECRI's comprehensive evidence-based studies examine safety and risks of materials used in implantable medical devices; research will aid…

Accelerating time to market with regulatory information management systems

ByDave Hadfield, Kalypso

16 Apr 21

Regulatory information management systems have existed for decades, but over time have matured significantly, especially in recent years

MHRA urges people to continue getting vaccinated following Irish suspension of AstraZeneca jab

15 Mar 21

The MHRA stated 'the evidence available does not suggest the vaccine is the cause' following reports of blood…

FDA warns 25 companies to stop producing fake regulatory certificates for medical devices

05 Mar 21

The FDA has written to 25 companies - including manufacturers, distributors and sellers - telling them not to…

Adoption of ‘incredibly helpful’ AI and ML technologies set to surge following FDA action plan

15 Feb 21

Last month, the FDA introduced a five-point action plan to help integrate AI- and ML-powered technologies into the…

Leading medtech association ‘very concerned’ by EU export restriction on Covid-19 vaccines

03 Feb 21

In the past week, the WHO, Canada and Japan have also criticised export restrictions introduced by the EU…

Four recommendations for better digital health regulation driven by the pandemic

By Peter Littlejohns

22 Jan 21

MedTech Europe has recommended several of the changes made to digital health regulation in Europe during the pandemic…