Medical Device ISO 14971 Risk Management Training Services.

QSR 820 system counselling in the United States, BGMP system counselling in Brazil, JGMP system counselling in Japan, KGMP system counselling in Korea, UKCA QMS system counselling in the United Kingdom, FDA factory inspection counselling in the United States; and medical device system counselling in other countries.

MDSAP, Medical Device Single Audit Program MDSAP is a third party audit and assessment programme developed by the IMDRF organisation in 2014 to improve the safety and surveillance of medical devices for trade, resources and services. The aim is to achieve uniform recognition among different MDSAP member countries (TGA Australia, ANVISA Brazil, FDA USA, HC Canada, MHLW & PMDA Japan) through a single audit process.

ISO13485 in Chinese is called ‘medical device quality management system for regulatory requirements’ As medical devices are special products to save lives, prevent diseases and cure diseases, it is not enough to regulate them only according to the general requirements of ISO9000 standard, for this reason, ISO organisation has issued the standard of ISO13485:1996 (YY/T0287 and YY/T0288) to put forward special requirements for the quality management system of medical device manufacturers to achieve safety and effectiveness. T0287 and YY/T0288), which puts forward special requirements for the quality management system of medical device manufacturers and plays a good role in promoting the quality of medical devices to be safe and effective.
The executive version from November 2017 till now is ISO13485:2016 ‘Requirements for the use of quality management systems for medical devices for regulatory purposes’. The name and content have been changed compared to the previous version.

Egypt medical device registration agent service, Oman medical device registration agent service, Colombia medical device registration agent service, Argentina medical device registration agent service, India medical device registration agent service, Mexico medical device registration agent service, Singapore medical device registration agent service, Malaysia medical device registration agent service, Thailand medical device registration agent service, Vietnam medical device registration agent service. Registered Agent Service, Ukraine Registered Agent Service, Russia Registered Agent Service, South Korea Registered Agent Service.

The United Arab Emirates, or UAE for short, with its capital in Abu Dhabi, is an Arab country bordering Saudi Arabia. In the UAE, medical devices and in vitro diagnostic medical devices are regulated by the Drug Control Department under the Ministry of Health and Prevention (MOHAP).
It is worth noting that foreign companies in the UAE need to find a legitimate local agent to submit medical device classifications and registrations and to communicate with MOHAP. At the same time, the local representative in the UAE also has a very important role that cannot be replaced, that is, the applicant for the import permit, only through the local representative can be carried out after the product has been certified import permit application and issuance, which means that your local representative still need to assist you to complete the subsequent import issues.

SFDA, The Saudi Food and Drug Authority. The body responsible for regulating, supervising and monitoring food, medicines and medical devices, as well as setting mandatory standards and norms, and for monitoring and/or testing activities in laboratories of the SFDA or other agencies. In addition, the SFDA is responsible for consumer certification in all matters relating to food, drugs and medical devices and all other products and supplies.
The Saudi Medical Devices Sector (MDS) plays a key role in ensuring the safety, efficacy and performance of medical devices under comprehensive legislation and regulation. The Saudi Medical Devices Regulatory Framework is aligned with international practices in terms of harmonisation and convergence, and it chairs the Global Harmonisation Working Party (GHWP) and is an active member of several technical committees of the IMDRF and ISO.
In December 2019, Saudi Arabia launched a new harmonised electronic system ‘GHAD’, which replaces the existing systems for marketing, registration and authorisation of medical devices (MDMA, MDNR and SFDA). From July 2021, local and foreign medical device manufacturers will need to register or renew their licences under the new GHAD system.
It is worth noting that a legal Authorised Representative (AR) needs to be identified locally to communicate with the SFDA for registration certification prior to SFDA registration in Saudi Arabia.

Medsafe (Medicines and Medical Devices Safety Authority) is the New Zealand government agency responsible for the regulation and management of medicines, medical devices and other medical products.Medsafe is responsible for evaluating and approving the registration of medical products, monitoring the quality, safety and efficacy of medical products, and supervising the production and distribution of medical products. Medsafe is responsible for assessing and approving the registration of medical products, regulating the quality, safety and efficacy of medical products, and overseeing their manufacture and distribution, etc. Medsafe's main task is to ensure that medical products available on the New Zealand market comply with national and international standards and requirements, and safeguard the health and safety of the public. To this end, Medsafe maintains close co-operation with other international pharmaceutical regulatory bodies to promote the safety and reliability of medical products.
If a medical device company has obtained CE marking from the European Union, FDA from the United States, or MDL/MDEL registration from Health Canada, it will need a local nominated sponsor (Sponsor) to list your product on MedSafe's WAND (Web Assisted Notification of Devices) database on MedSafe.
It is important to note that the local Sponsor is also licensed in New Zealand and is solely responsible and liable for the registration and listing of devices in New Zealand by foreign companies; is responsible for the accuracy of the information in the WAND and is the sole point of contact for Medsafe.