Voices TODAY THuRSDAY DECEMBER 15, 2011 26
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Today
we set you thinking HsA should review registration
process for medical devices
todayonline.com
Publisher Patrick Yong
Editor Walter Fernandez
Associate Editor Richard J Valladares
Associate Editor Yvonne Lim Letter from Huang Shoou Chyuan d (high risk, such as heart valves) devices restrict consumer choice and their access to
Editor-At-Large Conrad Raj
include a one-time s$500 application fee, new technologies”, ironically stated on the
Night Editor Razali Abdullah
Digital Media Editor Edric Sng Vendors of medical devices have com- followed by an abridged evaluation fee HsA website as something it wants to avoid.
plained recently that new regulations ranging from s$1,800 to s$5,700. I suggest that the HsA operates on a
News Editor Loh Chee Kong
Voices Editor Derrick A Paulo
by the Health sciences Authority (HsA) This is for devices approved by compe- cost-recovery basis. Application fees should
Foreign Editor Trixia Carungcong have increased business costs and would tent overseas regulatory agencies such as be lowered to s$50, and devices that have
Sports Editor Leonard Thomas threaten our status as a regional centre of the United states Food and drug Authority. been approved by other competent agen-
Features Editor Phin Wong
medical excellence. For devices not previously approved by any cies should not need re-evaluation.
Special Projects Editor Don Ong
Chief Sub-Editor Bachan Singh I did not take them seriously until my agency, higher evaluation fees apply, rang- Fees should be lowered to reflect the
Senior Product Manager Joni Ng enT (ear, nose, Throat) clinic’s equipment for ing from s$3,500 to s$11,400. paperwork done to verify documents,
ear assessment became spoilt beyond repair. The higher costs and our small market which should cost no more than s$200.
MediaCorp Press Ltd The distributor said that although (there are fewer than 40 private enT clinics Those not approved by any agency would
today@mediacorp.com.sg there were newer versions in the market, plus five enT departments in public hos- no doubt need evaluation by the HsA, but
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www.twitter.com/todayonline it is not importing them due to high costs pitals) have caused many vendors to give fees should be applied in a transparent
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and the risks involved in getting the HsA to up product lines. manner, reflecting actual work done.
caldecott Broadcast centre, Annex Building, Level 1,
Andrew Rd, singapore 299939 register and evaluate the devices. Those who register the products would Fee reduction would be win-win for all.
Tel 6236 4888 | Fax 6534 4217
circulation Hotline 1800 698 6329 The HsA website states that any medi- inevitably pass on the additional costs. Patients would be assured of proper
cal device (whose broad definition means Patients would lose out either way, as they certification of the medical devices, and
MediaCorp NewsHub
mediacorpnewshub@mediacorp.com.sg most devices in a typical clinic) needs to be would not get the newest technologies, or vendors could source for devices that doc-
TV Building, 2nd Floor, caldecott Broadcast centre, registered and evaluated before it is sold if they do, it would cost them more. tors need without worrying unduly about
Andrew Rd, singapore 299939
Tel 6251 7671 | Fax 6251 5352 to end-users. Undoubtedly, proper regulation of med- losing money if, after paying evaluation
MediaCorp Advertising Enquiries
registration for Class B (low to moder- ical devices is crucial for safeguarding public fees, they find that our small market dis-
Tel 6333 9888 ate risk, such as suction pumps) to Class health, but the cost should not “unduly advantaged them.