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The new government has announced plans to create an NHS-wide medical device licensing system that will allow manufacturers of new medical devices to apply to have their medical devices covered by the Health and Safety Executive (HSE).
In a press release, Minister for Health Simon Harris said: We are introducing legislation to provide the medical device industry with the ability to provide medical devices for their customers that meet the requirements of the NHS.
This will ensure that every patient receives the best possible care and that the NHS can continue to provide high quality care.
The press release did not specify which new medical device types would be covered.
There are currently no restrictions on the number of devices that can be licensed by a medical device manufacturer.
But a number of medical device makers, including Pfizer and Samsung, have expressed concerns that the licensing regime could be used to impose restrictive licensing conditions on their devices, such as restricting their ability to sell them internationally.
Some medical device manufacturers have also raised concerns about the impact of the HSE’s plans on their ability, or desire, to supply devices to the NHS, which is currently unable to cover all the medical devices manufactured by medical device manufactures in the UK.
Some manufacturers have been lobbying for the Hse to be granted blanket licensing for all medical devices, which would allow them to compete with the likes of Apple, Google and Samsung in terms of market share in the global medical device market.
Under the current licensing system, medical device companies have to pay the Hsie to license their devices.
They are also charged for providing data to the Hsi for the device’s data protection purposes.
The Medical Devices Regulations 2012, which was announced in October, outlines the licensing and control of medical devices in the NHS by the Hsien.
The regulations state that medical device licensees are not allowed to: restrict their customers’ use of the device to the extent that is is not necessary to carry out their medical purpose; or impose unreasonable or undue burdens on the medical use of a medical product, which could have a detrimental impact on patient care or quality of life.
This would apply to medical devices that have a medical purpose and can be used by a patient or for a medical procedure.
The rules do not require a medical practitioner to hold a licence.
However, it is currently illegal for a person to purchase a medical devices device without the approval of a licensed medical practitioner.
The licensing system would allow doctors to prescribe a device in accordance with their medical qualifications.
Under this system, a doctor would be able to prescribe devices to patients that meet specific requirements, such the ability for patients to use the device for a specific purpose.
In addition, a licensed doctor would have the right to prescribe medicines and devices, as well as the ability, if required, to sell devices to consumers.
In February, the Hhe Shing, a medical technology watchdog group, raised concerns over the proposed licensing system.
In a report titled “Medical Devices Regulations 2013”, it said: The proposed licensing scheme for medical devices is based on an unproven system which would prevent medical devices from entering the NHS in a way that is not required.
The proposed system will also put patients’ lives at risk.
The Hhe San, which represents a number different medical device industries including Philips, has expressed concern about the licensing system’s impact on its members and their ability or desire to provide their products to the public.
It has also warned that the proposed system would create barriers to competition, which may cause patients to stop purchasing medical devices.
However the Hreedy Commission, which advises the Hsing on medical device regulations, has not taken a position on the licensing issue.
This is due to the fact that it is not yet established whether the Hshe San has any say in the licensing of medical equipment, and is therefore not consulted on the issues raised in the report.
A spokesperson for the Medicines and Healthcare Products Regulatory Agency (MHRA), which regulates medical devices within the NHS said: Healthcare professionals and their patients have been in a state of uncertainty for some time now over the licensing arrangements for medical products.
This has resulted in many concerns being raised about the proposed legislation.
We welcome that the Hfe San has now taken a stand on this matter, and have been working with the medical industry to bring clarity to the licensing issues.
The MHRA is the regulatory authority for the sale and use of medical products within the public sector.
Under current legislation, there is a limit of four devices per person per year.
However under the proposed scheme, a device can be sold to anyone, with no limit on the total number of patients that can buy the device.
This could make it difficult for some medical device owners to access the supply of the devices that they need.
It is estimated that over half of all NHS patients use a device.
The Medicines Act 2003 states that any device that is ‘implemented in the public interest’ must meet a number in the ‘common use’ category.
This category means that the device is not necessarily commercially available and is not marketed by