Medical e-News Round-Up - Issue 48

This issue covers:

New bill will make distinction between devices and drugs in India

A medical device makers body in India has welcomed new medical device legislation that it says will enable the industry to serve the needs of Indian patients in a better way.

The Drug and Cosmetics Bill is awaiting passage through India's Parliament and for the first time would include specific regulations for medical devices and would address the marketing approval process for the medical device industry.

AdvaMed, the Advanced Medical Technology Association of medical device manufacturers said that currently out of the 14,000 types of medical devices that exist, only 22 are on the government's list and even these are currently treated in the same way as drugs.

The body said that the Bill is a benchmark legislation as it outlines a regulatory system that is appropriate for medical devices and is broadly harmonised with international regulations.

Sanjay Banerjee, Chair of AdvaMed India, said: "The Bill is historic because it creates a distinction between drugs and medical devices for the first time in India's legislative history.

"We believe that by establishing an appropriate regulatory framework for medical devices, it will enable industry to better address the needs of Indian patients.

"The obfuscation of the two categories in India has created ambiguity about safety standards and quality control, and limited the ability of the medical device industry to address issues of access, availability, affordability and safety,".

"It will ensure quality of medical devices, patient safety and remove bottlenecks to easy availability. It will grow domestic manufacturing capacity, allow domestic industry to compete globally and incentivise international industry to invest and 'Make in India'." More information at www.business-standard.com

Uni-Therm ensures electrosurgical devices remain in spec

Investment in advanced test instrumentation from Rigel Medical is helping a specialist supplier of veterinary and medical equipment verify the performance and safety of important electrosurgical devices.

Bristol-based Freelance Surgical Ltd. is an established and market leading medical equipment company specialising in the supply of operating and ITU equipment, as well as other medical supplies, to veterinary practices and hospitals.

As part of a rigorous quality control policy the company is using an advanced Uni-Therm unit from Rigel Medical to ensure that all equipment remains compliant with the relevant medical device standards and performs within required specifications.

The Uni-Therm carries out a range of tests in line with the IEC 60601-2-2 type testing standard for electromedical equipment, using its unique load bank and current measurement technology to stimulate the behaviour of body tissue.

As a result, the instrument can accurately analyse the performance of all types of surgical generators across a wide range of impedances, including those operating at high current levels.

The Uni-Therm enables the Freelance Surgical engineers to upload the power distribution curves of different items of equipment for automatic comparison against preset power curves over time and to manufacturer’s specifications.

Upper and lower limits of performance can be established and tolerances refined to ensure that operational norms are maintained.

Steve Griffiths, service manager at Freelance Surgical, explained: “Users of specialist electromedical devices should understand that more rigorous analysis and testing is required than that provided by conventional portable appliance testing.

“The simple to operate technical capabilities of the Uni-Therm mean we can reliably and regularly analyse devices, monitor the results over time and identify any changes to performance that should be rectified.

“This higher level testing means we can give customers much more comprehensive service reports, alongside the confidence that their important electromedical equipment continues to be fit for purpose.” More at www.rigelmedical.com/uni-therm

Click here to see the Uni-therm in action and to download your free guide to Electrosurgery

FDA encourages improved access to medical devices

The US FDA has introduced new measures to reduce the time and cost of clinical trials associated with new medical devices while maintaining patient protections.

By doing so, the FDA is helping to ensure that manufacturers will be more likely to conduct their clinical studies in the USA, enabling patients to have earlier access to innovation.

Writing in a blog on the FDA’s website, Ben Fisher, Director, Division of Reproductive, Gastro-Renal, and Urological Devices, in the Office of Device Evaluation at the Center for Devices and Radiological Health, said: “One way the FDA can reduce the time and cost of a clinical trial is to determine if publicly available clinical data for medical devices with which we have considerable experience can be leveraged to develop a less burdensome clinical trial design.

The FDA has also established a strategic priority of strengthening the clinical trial enterprise. This includes finding ways to streamline clinical trials so that fewer resources are required to bring a new device to the market.

Ben Fisher said: “Through strengthening the clinical trial enterprise, we hope to encourage manufacturers to study new and important medical devices in the USA, helping us fulfil our vision of providing patients with high-quality, safe and effective medical devices of public health importance first in the world.” Full details at www.fda.gov/MedicalDevices/

China issues more standards for medical devices

In an effort to ensure the continued safety and effectiveness of medical devices, the China Food and Drug Administration (CFDA) has made a number of changes to the country’s regulatory framework for product certification.

The CFDA has recently issued a further 90 industrial standards for medical devices. Of these, 14 are to be mandatory standards concerning inter alia haemodialysis and laser corneal refractive therapy equipment and will come into effect on 01 January 2017. The remaining 76 recommended industry standards concern implants for surgery, medical electrical equipment, in vitro diagnostic reagents, and equipment for dentistry and will come into effect on 01 January 2016.

These new 90 standards are in addition to the 120 industry standards already announced in July 2014 and bring the total number of medical device standards to over 700. Although most of the guidance is similar or equivalent to the European harmonised standards, some versions incorporate local variations.

Demand for medical devices is increasing in China, especially in the wealthier urban areas, and the total value of the Chinese medical device market is estimated at over $17-billion.

Hong Kong regulators issue list of medical device standards

Regulators in Hong Kong have published a new list of recognized standards applicable to medical devices as the region moves toward more formal oversight of its device market.

The Hong Kong Medical Device Control Office’s (MDCO) list is intended as a reference for in-country representatives (Local Responsible Persons) in order to demonstrate safety and effectiveness of their manufacturers’ products.

The MDCO list includes standards from the International Standards Organization (ISO) and International Electrotechnical Commission (IEC). MDCO has included ISO 15223 for medical device symbols.

In the introduction to the new list, the MDCO notes that not all requirements for listing a device may be addressed by recognised standards, especially for new types of devices and emerging technologies. In these cases, other supporting documentary evidence should be submitted for evaluation, which may involve relevant industrial or factory standards.

Find out more at www.mdco.gov.hk