HSA Registration Process Too Bureaucratic, Docs Claim

American doctors apparently are not alone in their disdain for government bureaucracy. Their counterparts in Singapore seem to detest red tape as well.

In recent months, physicians in the island country have become more vocal about their contempt for a Health Sciences Authority (HSA) stipulation that requires them to register all medical devices for clearance before use. One of the major complaints with the new regulation—which took effect Jan. 1—is the time and cost involved in registering devices. Doctors claim that registration can take several months (detailed information must be provided by the manufacturer) and cost several thousand dollars, making it difficult and expensive to introduce new products to the market.

Another main grievance with the government’s revised record-keeping strategy is the vast array of products that now must be registered. Under the HSA’s “risk-stratified” regulatory framework, thousands of items are considered medical devices—from simple products such as bandages, wheelchairs, contact lenses, catheters and digital blood pressure monitors to more complex equipment like heart valves and magnetic resonance imaging machines.

Such a broad definition has significantly increased red tape and is dis-couraging many manufacturing firms from registering inexpensive devices, some doctors argue. Eye specialist Jerry Tan, for one, believes the registration process is too troublesome and pricey, particularly for low-cost, low-volume medical devices.

“These devices cost less than $50 (RM 121) and no company wants to register these devices for us as there is no profit to be made,” Tan told The Sunday Times of Singapore.

HSA officials, however, insist the tightened registration process is designed to ensure patient safety. “A patient who receives a cardiac pacemaker implant would want the device to perform reliably for the years that it remains in the body. Failure of such devices can have life-threatening consequences,” Singapore Minister of State Dr. Amy Khor said at an April 20 Town Hall session with the device industry. “Even simple medical devices such as contact lenses, if not properly made or used, could lead to lifelong disability and blindness with huge public health impact if product penetration to the population is extensive.”

Khor’s statement was not meant as a warning but rather a sobering re-minder of the potentially damaging consequences of faulty devices. To better safeguard patients from defective equipment, Singapore has slowly revamped its medical device regulations over the last five years, modeling them after those in Europe, the United States, Canada, Australia and Japan. But the new system is far from perfect; during her springtime speech to industry executives, Khor acknowledged that Singapore’s medical device requirements need “constant refinement and tweaking.”

Some of the tweaking already has begun. On May 1, for instance, the HSA exempted all non-sterile, lowest-risk Class A devices from the clearance process (sterile products with the CE Mark blessing will move through the system more quickly, Khor promised). The May 1 exemption covers roughly 2,700 Class A product types and brings the total number of exempted Class A items to nearly 4,700, or 80 percent of all such devices.

The HSA also is reviewing its fee framework to “better stratify” its pricing structure for devices. Last month, the agency implemented a lower-tiered fee schedule for low-cost, low-volume devices introduced through Special Authorisation Routes (the new fee schedule took effect Aug. 1).

This month, the HSA has promised to introduce two fast-track approval processes for moderate risk Class B devices. The first is an immediate registration route for devices approved by two HSA reference agencies (the candidates being the U.S. Food and Drug Administration, the European Union, Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency, and Australia’s Therapeutic Goods Administration). To qualify for “immediate registration,” devices also must have a clean safety record for at least three years.

The second accelerated registration process is limited to Class B devices that have been approved in two reference agencies or in one of those entities and sold either in one of those markets or in Singapore. Like the first fast-track approval process, these products also must have clean safety records for at least three years.

HSA officials expect the expedited registration system for Class B devices to impact more than 3,500 applications, or roughly 85 percent of current Class B submissions. The agency may use similar benchmarks (reference agencies and safety records) to eventually create an accelerated process for higher-risk Class C and Class D devices.

In addition to its tweaks and technical tuning, the HSA has pledged to work with the Singapore Manufacturers’ Federation to create a “concierge service” that helps companies with various pre- and post-marketing services, including training and consultation.

The industry also can help untangle some of the additional red tape from the new regulations by changing the way medical devices are marketed. For example, dealers can check with more purchasers first before grouping devices under one application, and non-institutional doctors can band together to buy a larger quantity of consumable items, Kohr suggested.

Still, patient safety must be at the heart of any refinement effort, HSA officials insist.

“We want to instill the sense of safety in doctors,” Dr. Raymond Chua, deputy group director of the HSA’s Health Products Regulation Group, told The Sunday Times. “You can’t quantify a cost to safety.”