普瑞纯证GRIP平台|bg

Pure Global's GRIP platform-Regulatory Radar

A simple mobile phone registration and then totally free to use. Covers regulatory trends of 100+ countries/regions around the world and analysis of PureFDA's experts.

24

2024-05

Vyaire Medical, Inc. Recalls the Twin Tube Due to The Potential of The Nozzle Separating During Patient Use

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. ㅤ ㅤ ㅤ

FDA

23

2024-05

Bistouri électrique (plaque) – Megadyne Mega Soft Electrode de retour patient pédiatrique – Megadyne Medical Products / Johnson & Johnson Medical SAS

Information for indoor pharmacies and healthcare establishmentsㅤ ㅤ ㅤ

The National Agency for the Safety of Medicines and Health Products

23

2024-05

TCOKKA- TIBBİ CİHAZ ÜRÜN GELİŞTİRME SÜREÇLERİ ÇEVİRİM İÇİ TOPLANTISI

Turkish Medicines and Medical Devices Agency

23

2024-05

Field Safety Notices: 13 to 17 May 2024

If you receive a field safety notice (FSN) from a manufacturer you must always act on it. MHRA publishes the following for information only. If you have a question about a particular FSN contact the manufacturer.ㅤ ㅤ ㅤ

Medicines and Healthcare products Regulatory Agency

23

2024-05

Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices

U.S. FOOD & DRUG ADMINISTRATION

23

2024-05

美敦力导航股份有限公司Medtronic Navigation, Inc.对脑外科手术导航系统、脊柱外科手术导航系统、耳鼻喉科手术导航系统主动召回

美敦力(上海)管理有限公司报告,由于软件异常可能导致活检针限深点设置错误等原因,生产商美敦力导航股份有限公司Medtronic Navigation, Inc对其生产的脑外科手术导航系统Cranial Treatment Guidance System(国械注进20183010514)、脊柱外科手术导航系统Spine Treatment Guidance System(国械注进20183010510)、耳鼻喉科手术导航系统ENT Treatment Guidance System(国械注进20183010507)主动召回。ㅤ ㅤ ㅤ

National Medical Products Administration

21

2024-05

Open consultation Common specification requirements for in vitro diagnostic devices

MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices. This consultation closes at 11:59pm on 14 June 2024ㅤ ㅤ ㅤ

Medicines and Healthcare products Regulatory Agency

21

2024-05

Optima Coil System et Prestige Coil System – Balt USA

Information destinée aux établissements de santéㅤ ㅤ ㅤ

The National Agency for the Safety of Medicines and Health Products

21

2024-05

TCOKKA – 2024/2 sayılı Tıbbi Cihaz Yönetmeliklerine ilişkin Genelge

Turkish Medicines and Medical Devices Agency

24

2024-05

MHRA announces a proposed framework for international recognition of medical devices

This initiative signals an important step towards a new regulatory framework for medical devices in Great Britain which protects public health, ensures access to MedTech innovations, and maintains an attractive market for industry ㅤ ㅤ ㅤ

Medicines and Healthcare products Regulatory Agency

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