How do I register my medical device in Hong Kong?
Medical Device Administrative Control System (MDACS) registration. Hong Kong currently has no mandatory registration for medical devices, but manufacturers and importers can opt for voluntary registration under the Medical Device Administrative Control System (MDACS).
How do I get a medical device approved in Europe?
In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements of the Medical Devices Directive (MDD), or Active Implantable Medical Device Directive (AIMD) as they apply to your product.
Who is the regulatory body for medical devices in Europe?
the European Medicines Agency (EMA)
They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process.
What constitutes a medical device?
A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.
How do I sell my medical device in Europe?
Every medical device before being sold in Europe requires a CE mark, even if the product is imported from outside the Economic European Area (EEA). The CE mark certifies that a medical device complies with essential requirements stipulated by the European Regulation (MDR 2017/745 and IVDR 2017/746).
Who needs to register with MHRA?
You must register if you or your company sells, leases, lends or gifts: Class I, IIa, IIb or III devices you have manufactured. Class I, IIa, IIb or III devices you have refurbished or re-labelled with your own name. any system or procedure pack containing at least one medical device.
How do I sell my medical devices in Europe?
To sell medical devices in the European Union (EU), you must obtain CE Marking for your product. CE Marking indicates that your medical device complies with applicable EU regulations, and enables the commercialization of your products across all EU member states.
Do all medical devices need FDA approval?
Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use.
What is a Class 1 medical device EU?
Medical Devices Categorization in Europe Class I being the lowest risk ones and Class III the highest risk ones. There are also 3 “subclasses” in the Class I category: Class I provided in sterilized condition (Cl Is) are simple devices but which have been sterilized by the manufacturer, such as a vaginal speculum.
What are the main European directives that apply to medical devices?
These two new Regulations, namely, Regulation (EU) 2017/745 relating to medical devices (MDR) and Regulation (EU) 2017/746 relating to in vitro diagnostic medical devices (IVDR), entered into force following publication in the Official Journal of the European Union in April 2017.
Do medical devices need MHRA approval?
all medical devices, including in vitro diagnostic medical devices ( IVDs ), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market.
How long does it take to register with MHRA?
Registering for the MHRA Gateway On receipt of your registration request, the MHRA will aim to complete your registration within 5 working days.
How to register a medical device in Europe?
Please click here the European commission medical device website and for more information on medical device registration in Europe. 1) The first thing you need is to get a qualified PRRC (person responsible for regulatory compliance). Usually it is the same person who the management representative as defined by ISO 13485.
Who regulates medical devices in Europe?
They are regulated by national competent authorities, but the European Medicines Agency (EMA) is also involved in the assessment of certain categories of medical device under European Union (EU) legislation.
What are the regulations on medical devices?
The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of certain categories of medical device.
What does the Medical Devices Regulation mean for EMA?
The Medical Devices Regulation foresees that the European Commission may consult the Agency on products that borderline with medicines. EMA’s Innovation Task Force provides advice to medicine developers on eligibility to EMA procedures relating to the research and development of borderline products.