Sunday, December 11, 2011
Health Sciences Authority's high cost of registering medical devices needs urgent review
I was ( and still am) extremely concerned that certain of HSA’s (Health Sciences Authority) regulations can potentially cause great harm to Singapore’s healthcare industry directly and the welfare of our patients indirectly.
Distributors of medical devices are finding that it is not economically viable to bring in much needed medical devices. These distributors are not just from my specialty but from all medical and surgical disciplines.
I felt that if something were not done quickly to rectify this, this might signal the start of our decline as a Regional Centre of Medical Excellence.
Hence, being the good citizen that I am, I wrote to a person of very high standing in the Ministry of Health and to the press. However, I did not even get an acknowledgement much less a response from the MOH. I don’t think the forum editors feel this issue of enough mass appeal for publication either.
Just in case the powers-that-be think I am a rabble-rouser ( or shit-stirrer), I am not.
Whoever has the ear of the powerful, please feel free to forward this to the relevant authorities.
Dr Huang Shoou Chyuan
Health Sciences Authority’s (HSA) registration procedure for Medical devices needs urgent review
I did not take seriously the complaints by vendors of medical devices, who claim that new regulations by Health Sciences Authority (HSA) have added significant cost to doing business as well as threaten our status as a regional centre of medical excellence, until it affected me personally.
My ENT clinic’s audiometric equipment for ear assessment became spoilt beyond repair and when the distributor revealed that although there is a newer version in the market, they are not importing it due to high costs and risks involved in getting these devices registered and evaluated by HSA.
HSA’s website states that any medical device (whose broad definition means almost everything one sees in any typical medical clinic and range from the mundane eg suction pump, to the complex eg heart valve) needs to be registered and evaluated before sale to end-users. Click here.
HSA’s high fees (click here)
Registration for Class B ( low-moderate risk eg suction pump) to Class D (high risk eg heart valves) devices include a one time application fee of $500 followed by an “abridged” evaluation fee ranging from $1800 to $5700 if these had already been approved by competent overseas regulatory agencies such as USA’s FDA (Food Drug Authority) or European Union etc.
If not previously approved by any agency,higher evaluation fees ranging from $3500 to $11400 apply.
No device is exempt (not even if these had already been evaluated and approved by America's FDA which has a reputation of being very stringent). In fact, I was told that sponges ( which come in various sizes) used for packing after nose surgery have to be individually registered!
The higher costs and our small market (there are less than 40 ENT clinics plus 5 ENT departments in the restructed hospitals) have caused many vendors to give up product lines. Those that do register the products would inevitably pass on the additional cost to the end-users. In both scenarios, the patients will be the losers as either they will not be getting the newest technologies or if they do, it costs them much more.
Proper regulation of medical devices is crucial for “safeguard(ing) public health” but the cost for this should not “unduly restrict consumer choice and their access to new technologies”- ironically mentioned on HSA’s website as something it wants to avoid.
I suggest that HSA operates on a cost-recovery basis. Application fees should be lowered to $50 and those devices that had prior approval by other competent agencies should not need re-evaluation and hence fees should be lowered to reflect the paperwork done to verify documents which should cost no more than $200.
Those not approved by any agencies would of course need evaluation by our competent local agencies but fees should be applied in a transparent manner reflecting actual work done.
Fee reduction will mean a win-win for all. Patients will feel assured that our medical devices have been properly certified and vendors can source for devices that their doctors need without worrying unduly about losing money if after paying huge fees for evaluation find that our small market disadvantaged them.
Dr Huang Shoou Chyuan
(NB: Dr Huang holds several offices in various medical committees at different levels but writes this in his personal capacity. He does not have any financial interest in any medical device companies. )