It is approaching the deadline for the MDEL renewal, the Medical Device Establishment Licence in Canada. According to the Guidance …
Continue reading “CANADA: MDEL license renewal within 1 April and commissions update for MD”
Without an agreement, Switzerland will probably become a Third Country in the Medical Devices sector. We are with bated breath for …
Continue reading “MDR: will Switzerland become a Third Country in the Medical Device Sector?”
On 23 December 2020, new Post-Market Surveillance (PMS) requirements for Medical Devices were published in the Canada Gazette, Part II …
Continue reading “CANADA: new PMS requirements for Medical Devices published”
By reading our White Paper “Labelling: instructions for use” you will get detailed information on: the instructions for use (IFU) requirements in …
Last month, the U.S. Food & Drug Administration (FDA) published online information on Certificate for Device Not Exported from the …
Continue reading “USA: FDA issues Certificate for Devices not Exported from U.S.A. (CDNE)”
Last 19 October 2020 the Health Sciences Authority (HSA), Singapore’s Regulatory Authority, announced that it will be introduced a UDI …
Continue reading “SINGAPORE: next introduction UDI system for Medical Devices”
On 18 September 2020, the National Health Surveillance Agency of Brazil (ANVISA) published the Resolution RDC n. 423/2020 declaring the …
Continue reading “BRAZIL: Cadastro eliminated also for Class II medical devices”
On September 3, 2020, the Indian Central Drugs Standard Control Organization (CDSCO) published the “Notice regarding classification of non notified …
Continue reading “INDIA: new categories for the classification of non notified devices”
On July 1, 2020, FDA published the update of the “Unique Device Identification: Policy Regarding Compliance Dates for Class I …
Continue reading “FDA postpones to September 24, 2022 the UDI for Class I and Unclassified”
On June 26, 2020, CEN (European Committee for Standardisation) and CENELEC (European Committee for Electrotechnical Standardisation) rejected the implementing decision …
Continue reading “Implementing decision M/565: CEN and CENELEC reject EC request”