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Health Canada: new PMS requirements for Medical Devices

WebFloor 4. Philadelphia, PA 19104. Tel. +1 215-845-9459. info@thema-med.com. On 23 December 2020, new Post-Market Surveillance (PMS) requirements …

Actived: 1 days ago

URL: https://www.thema-med.com/en/2021/01/25/health-canada-new-pms-requirements-medical-devices/

CANADA: Summary Reports required

WebTel. +39 0542 643496. Fax. +39 0542 641833. [email protected]. Health Canada, the department of the Government of Canada responsible for national …

Category: Health Go Health

BRAZIL: ANVISA provides an online database for adverse events

Web2929 Arch Street, Floor 4. Philadelphia, PA 19104. Tel. +1 215-845-9459. [email protected]. In order to reinforce the notification and monitoring system in …

Category: Health Go Health

CANADA: management of device recalls with the new “Medical …

WebCANADA: management of device recalls with the new “Medical Devices recall guide”. In order to explain sections 63-65 of the MDR (Medical Devices Regulations), …

Category: Medical Go Health

CANADA: new fees for Medical Devices from 1 April 2023

WebThe Department of Health, Health Canada published the Fees in Respect of Drugs and Medical Devices Order, the annual adjustment of the new fees for Medical …

Category: Medical Go Health

Medical Device Registration in U.A.E.

WebMedical Devices are regulated by the Ministry of Health (MoH) through the Registration and Drug Control Department (DCD). UAE regulations state that the only parties authorized …

Category: Medical Go Health

CANADA: Changes to recall procedures and establishment …

Web2929 Arch Street, Floor 4. Philadelphia, PA 19104. Tel. +1 215-845-9459. [email protected]. On 15 April, Health Canada published the Amending the Food …

Category: Food Go Health

CANADA: updated list of recognized standards for Medical Devices

WebThe new list of recognized standards came into force officially on February 25, 2019. In addition to adding and deleting, Health Canada has substantially updated …

Category: Health Go Health

Medical Device Registration in Japan

WebTimeframe and fees. The registration of Medical Devices in Japan (Pre-Market Approval and Pre-Market Certification) is complicated, expensive and will generally take from 1 to 3 …

Category: Medical Go Health

Medical Device registration in Israel

Web2929 Arch Street, Floor 4. Philadelphia, PA 19104. Tel. +1 215-845-9459. [email protected]. Regulatory Authority Medical Device Division of the Israeli Ministry of Health …

Category: Medical Go Health

BRAZIL: new rules for Medical Devices design changes

WebPhiladelphia, PA 19104. Tel. +1 215-845-9459. [email protected]. Recently ANVISA has published two regulations RDC 340/2020 and IN 61/2020, …

Category: Health Go Health

Medical Device Registration in Italy

WebMedical Devices shall bear the CE marking and they are subject to registration with the Italian Ministry of Health database. In the case of a non-European Manufacturer it is …

Category: Medical Go Health

Marketing in Canada: what is the difference between MDAL and …

WebPhiladelphia, PA 19104. Tel. +1 215-845-9459. [email protected]. MDAL and MDEL are the acronyms of Medical Device Application License and Medical …

Category: Medical Go Health

SOUTH EAST ASIAN: Medical Devices regulatory updates

Web2929 Arch Street, Floor 4. Philadelphia, PA 19104. Tel. +1 215-845-9459. [email protected]. Below there are the latest news on the regulatory updates of …

Category: Health Go Health

Health Canada updates fees and introduces the “small business”

WebFrom April 1, 2020 Health Canada has updated licensing fees and the registration of medicines and Medical Devices according to the consumer price index.It …

Category: Medical, Medicine Go Health

TURKEY: amendments to Medical Devices sales and advertising …

Web2929 Arch Street, Floor 4. Philadelphia, PA 19104. Tel. +1 215-845-9459. [email protected]. Recently, the Turkish Medicine and Medical Devices Authority …

Category: Medical, Medicine Go Health

Medical Device Registration in South Africa

WebNo Medical Device may be manufactured, distributed, imported, exported or sold without a valid SAHPRA establishment license. Information on the Medical Devices to be marketed …

Category: Medical Go Health

BRAZIL: Revision of IVD Device Regulation

WebPhiladelphia, PA 19104. Tel. +1 215-845-9459. [email protected]. In December 2023, the Brazilian National Health Surveillance Agency (ANVISA) updated …

Category: Health Go Health