HSA eases registration of medical devices

It tweaks scheme after complaints from doctors and importers
By Salma Khalik, The Straits Times, 21 Apr 2012

THE medical device registration framework will be reviewed to eliminate the need to register thousands of low-risk medical devices including wheelchairs and hospital beds.

Thousands more will also see faster approvals from the Government at a lower fee.

The sweeping changes, to be implemented as early as next month, were announced yesterday by the Health Sciences Authority (HSA).

They come in response to feedback from doctors and importers who have complained that a backlog of approvals and high registration costs have reduced the range of medical devices imported and delayed their arrival.

In announcing this decision yesterday, Associate Professor John Lim, chief executive of the Health Sciences Authority (HSA), said the aim of the 'radical changes' was 'to provide faster access and lower fees without compromising safety'.

As a first cut, all low-risk Class A devices - except for sterile devices such as blood collection tubes - will be exempt from registration. This affects 4,700 items like wheelchairs and hospital beds and will take effect from next month. Class B products such as catheters and hypodermic needles, which are low to medium risk, will be divided into three groups, depending on whether they have been registered and used elsewhere.

There will be no change for about 650 Class B devices, but for 3,650 devices, the time taken will be cut from five to three months, with some getting immediate registration. The registration cost will also go down from $2,300 to $1,400.

This change is targeted to start in September.

Prof Lim said further tweaks will come as the HSA reviews the entire registration framework, including the registration of high-risk devices such as stents and pacemakers which are inserted into the body.

Minister of State for Health Amy Khor told The Straits Times that changes to the higher-risk devices will, 'at the latest', be next year.

Doctors and importers have been vocal in complaining about the difficulties they face with the new rules that came into effect in January, making it mandatory for all medical devices to be registered.

Their main complaints were the length of time needed to register their tools - from three to 16 months; the high cost of up to $11,900 per device; and whether it was necessary for the HSA to assess devices that have already been approved in places like the European Union, Japan and the United States.

They had argued that the cost and complexity of registration, as well as the time taken to process applications, would push up health-care costs and reduce the number of devices in use here.

Prof Lim said that the regulatory authority could not implement the changes earlier because 'we didn't get the full picture until registration started'.

'We take all the feedback as valid and we take it seriously,' he added.

Fee refunds will be given to about 1,500 Class A and 2,300 Class B applications. There will be no refund for devices already registered.

Prof Lim said similar changes will be made to the higher-risk Class C and D devices at a later date.

For niche devices which are relatively cheap and low in demand, but which doctors say are essential to their work, he said the HSA will speak to the Academy of Medicine, the society of specialists, to list these products for review.

Dr Huang Shoou Chyuan, a specialist in ear, nose and throat in private practice, who had given his view on the matter, said yesterday: 'This is good news. I look forward to such logical tweaking for Class C and D too.'

Meanwhile, the HSA has asked the Singapore Manufacturers' Federation (SMa) to help train importers on how to fill in applications properly. Smaller importers, without the manpower or expertise, have been employing consultants who charge between $350 and $5,000 per device.

SMa president George Huang said he was 'heartened' by the HSA's move, and praised it for being 'open and receptive'.

Amy Khor explains kinks in registration of devices
By Salma Khalik, The Straits Times, 21 Apr 2012

SINGAPORE is the first country in South-east Asia to register medical devices, and it is a complex job with no 'intuitive' rules.

Moreover, this comes as the United States and countries in Europe face pressure to tighten regulation after a spate of highly publicised device recalls.

The Minister of State for Health, Dr Amy Khor, made these remarks yesterday at a closed townhall meeting with 370 device importers to explain why there were kinks in the process which the Health Sciences Authority (HSA) is now ironing out.

They were also told of some of the changes coming to Singapore's medical device registration framework.

She said: 'Medical devices cover a wide range of products, and their classification and regulation can be complex and not always intuitive.'

Dr Khor told The Straits Times that the HSA, understanding the complex nature of the task, has been responsive to feedback all along. She added that the regulatory body would continue to tweak the process.

Since registration started in 2007, HSA has made several changes to help doctors, importers and manufacturers, Dr Khor said.

One example was the introduction of a 'transition' list, which allows all devices to continue being used here if application was received by the registration deadline, until the HSA has completed its assessment.

Non-registered devices can also be brought in through a special authorisation route.

For $500, doctors and importers were allowed to bring the device in for a named patient or institute for six months.

This window was later extended to one year, Dr Khor said, and the HSA has allowed a group of doctors to band together to make one application, instead of each doing it individually.

'The principle has always been that we're open and responsive to feedback,' she added.

After the townhall meeting yesterday organised by the Singapore Manufacturers' Federation, where the new changes were announced to the group, Dr Khor said that the reaction was largely positive.

But there were some who asked for more help, such as cutting the registration costs and getting the devices to market faster.

When asked why the HSA had not reacted earlier, Dr Khor said the 'bottleneck' came only at the end of last year when the application deadline for the lower-risk devices became effective.

There are more than 10,000 lower-risk devices, compared with 5,600 higher-risk ones which had to be registered by 2010, so many of the problems became apparent only recently.

However, in tweaking the system, Dr Khor said, the HSA will also review registration requirements and costs for these higher-risk devices - though greater caution was needed for these as they include devices such as pacemakers which are put into the human body.

Dr Khor said that these higher-risk devices would likely follow thesame tiered approach that will be introduced for lower-risk devices this year.

'The goal must always be that such regulations should not impede or add to the cost burden of the industry,' she said, adding that registration of medical devices is necessary for patient safety and to take health care here to a higher standard.

New rules get thumbs-up
By Poon Chian Hui, The Straits Times, 21 Apr 2012

DISTRIBUTORS, importers and manufacturers of medical devices breathed a sigh of relief at the new registration rules announced by the Health Sciences Authority (HSA) yesterday - but said there are still some kinks to be straightened out.

Many pointed to the lengthy process and collateral costs, though improvements were announced in these areas.

They gave some quick suggestions, including ways to make these processes even faster and cheaper:

- Having a pre-marketing approval scheme for firms to test new products on the market before registration.

- Allowing similar products or components that come in a set to be grouped more easily under one application.

- Having better-informed Customs officers, so that shipments will not be detained unnecessarily.

Despite the kinks, all described the move as a step in the right direction.

'This is what we have been fighting for,' said Mr Richard Lim, who owns Eastland Dental Supplies. Most of his products are affected by the changes.

Many firms say they now plan to scale up their range of products. Some reported having to drop as many as 10 items in the past year because of steep costs.

'Patients will have more choices - some products weren't being brought in. Now, importers will start bringing them back,' said Ms Jane Fong, managing director of ANTz Latex, which sells latex products such as surgical gloves.

Companies also hope for an easier time with foreign products. Speaking on the sidelines of yesterday's International Dental Exhibition and Meeting Singapore, marketing manager Glen Goh of Standard Dental said some products cannot be sold or tried out on people as they have not been HSA-registered.

Mr Henry Tan, president of the Association of Medical Device Industry (Singapore), said the next step would be to address market uncertainty - which is also holding companies back from introducing new products here.

He suggested that devices which have already received approval elsewhere can be made available here for up to two years. This way, companies can gauge whether they will be successful in the local market before spending thousands on registering them.

Some firms hoped that products which come in a set - for example, a knee implant, which has several components - can be registered together more easily.

'Sometimes a patient might need just one part of the product, but we have to get clearance. As a result, we might not be able to provide the service to the patient,' explained dental surgeon Dominic Leung, who runs a private practice.

In addition, some smaller firms have little choice but to hire external consultants who are well-versed in the regulations to help them with filing registrations. Fees could come to thousands a year. Some help with these fees would go a long way towards making products cheaper for patients, said Ms Fong.

Finally, while those firms whose applications are still pending are eligible for a refund of registration fees, others that have already completed the process are wondering if their money has gone down the drain. Said Mr Goh: 'Most of us have paid up. It's pretty much a done deal.'

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HSA Enables Faster and Expedited Access for Lower Risk Medical Devices through Enhancements to its Regulatory Framework