USA: FDA issues Certificate for Devices not Exported from U.S.A. (CDNE)
Last month, the U.S. Food & Drug Administration (FDA) published online information on Certificate for Device Not Exported from the [...]
SINGAPORE: next introduction UDI system for Medical Devices
Last 19 October 2020 the Health Sciences Authority (HSA), Singapore’s Regulatory Authority, announced that it will be introduced a UDI [...]
MDCG: ready EUDAMED Actor registration module
Last August 2020 the Medical Device Coordination Group (MDCG) published the document MDCG 2020-15 “MDCG Position Paper on the use [...]
USA: CDRH guidelines for fiscal year 2021 (FY 2021)
On 16 October 2020 the Center for Devices and Radiological Health (CDRH) of FDA published the list of guidelines it [...]
BRAZIL: Cadastro eliminated also for Class II Medical Devices
On 18 September 2020, the National Health Surveillance Agency of Brazil (ANVISA) published the Resolution RDC n. 423/2020 declaring the [...]
Latest FDA strategic guideline
In September 2020 FDA published some “Final Guidance Document” for companies operating in Medical Devices field. Latest FDA strategic guideline [...]
FDA: 7% fees increase for 2021
FDA has published fee schedule for the 2021 fiscal year (FY 2021) from October 1, 2020 through September 30, 2021, [...]
COVID-19: FDA actions to fight the pandemic continue to be carried out
In recent days, the United States has registered record data on Coronavirus infections. Over 500 thousand cases in one week. [...]
EU: companies ask the postponement of the IVDR (EU) 2017/746
As already happened for the Medical Devices Regulation MDR (EU) 2017/745, the European companies are mobilizing to request the postponement [...]
INDIA: new categories for the classification of non notified devices
On September 3, 2020, the Indian Central Drugs Standard Control Organization (CDSCO) published the “Notice regarding classification of non notified [...]
UK: BREXIT, what changes from 1 January 2021
On September 1, 2020 the Medicines and Healthcare products Regulatory Agency (MHRA) published new rules to be respected for placing [...]
EU: published guidance for Instructions For Use (IFU) for reusable devices
At the end of July 2020 the European Commission published a guide to address the issue of frequent non-compliance with [...]
SWITZERLAND: harmonization of the regulatory system to MDR is underway
Last July 2020 the Swiss Federal Council approved the revision of the Medical Devices Ordinance (MedDO), along with the new [...]
EU: MDCG published updated guidelines and new MDSAP audit
The Medical Device Coordination Group (MDCG) has recently published some updated guidelines as support for the implementation of the new [...]
USA: FDA guideline on electronic format sending for Medical Devices
The FDA guideline “Providing Regulatory Submissions for Medical Devices in Electronic Format - Submissions Under Section 745A(b) of the Federal [...]
Medical Devices registration in China: new procedures CMDE
Recently, the Chinese Centre for the Evaluation of Medical Devices (CMDE) published two announcements concerning new procedures for the medical [...]
FDA postpones to September 24, 2022 the UDI for Class I and Unclassified
On July 1, 2020, FDA published the update of the “Unique Device Identification: Policy Regarding Compliance Dates for Class I [...]
Implementing decision M/565: CEN and CENELEC reject EC request
On June 26, 2020, CEN (European Committee for Standardisation) and CENELEC (European Committee for Electrotechnical Standardisation) rejected the implementing decision [...]
