Sunday, December 11, 2011

Health Sciences Authority's high cost of registering medical devices needs urgent review

Dear Friends,

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

The letter:

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. )


Sgcynic said...

I am not sure whether this is a tongue-in-cheek suggestion or a genuine one - see your MP at the next MPS. That's what they are good for now, to direct your feedback/ complaints / pleas to the relevant department, which should then reply, unless if your MP does not wear white.

nofearSingapore said...

Sgcynic- my suggestions were genuine ones ( did they appear incredible to you?). I think MPS is usually for personal problems like summons/ application for citizenship etc and my concern was for our medical industry. Hence I wrote to the relevant authorities but apparently the authorities don't think my concerns were relevant. I am starting to think that we are living in a big "wayang" and change is long way from coming. Sigh! thanks for your very quick response.

Sgcynic said...

I believed that your concerns were genuine. I also believed you were deliberately ignored.

Sgcynic said...

When I wrote tongue-in-cheek, I meant my suggestion to see your MP. Sorry for the ambiguity. At least he cannot ignore you.

nofearSingapore said...

Sgcynics- thanks. I don't think I want to see my MP about this. How do I even start: Excuse me, Mr MP- I wrote to the MOH about this very serious and sincere concern of mine about HSA etc... I demand that you write in to the Minister and get a response for me immediately? Somehow- not quite right.

Sgcynic said...

At least raise the matter with him/her; they are supposed to take up cudgels for their constituents when they feel there is a cause aren't they? And there are a few doctors among them. Hope you get better suggestions from others.

rwkc said...

HSA's registration and evaluation fees have been presumably structured to give HSA revenue that would cover their overheads. That's how - unless I am wrong - a govt institution appears to operate- generate your own revenue vis-a-vis operating costs.

gks said...

HSA medical products regulation department has grown to become a mini monster of sorts akin to FDA, reviewing products that had been granted approvals by agencies such as FDA.

It is increasingly difficult to stay at the leading edge of medical technologies because all new medical technologies are subjected to HSA's scrutiny before they can be imported and/or used on humans.

Anonymous said...

"I am starting to think that we are living in a big "wayang" and change is long way from coming. Sigh! thanks for your very quick response.
8:06 PM, December 11, 2011".

Dear Doctor Huang;

we should not depend or hope for change to be coming from the Leadership. Near 5 decades of running us as they(leaders) like, have they ever made living better for us?

change will have to be made by the citizenry. If the citizenry remains as indifferent as in GE2011, Singaporeans will have to leave Sin for change.


Anonymous said...

dr huang you see today mrt stop again. you see how many times the mrt has stopped.

you see the ceo still sitting there.

if i am the ceo i will already quit 1 year or maybe even two years ago.(you should koe the vandalise mrt case as well right).

haiya sometimes i feel like giving up. feel like joining the white better, easier life.

but i will not.

you are my example of not giving up.

we will do it. if not 5-10years later, it will surely be 15 to 20years time.

time flies.

very soon we will win.

Anonymous said...

Many younger Singaporeans can wait.
Have any of You thought of the older folks who will be gone before the next 2 decades are up.
Dr Huang is too forgiving and too positive, he expect changes and hope for changes. This could give rise to false hope by his providing glimmers of hope which has never been realized.

Anonymous said...

Regulatory framework for devices is sound: HSA
Letter from Christina Lim Group Director, Health Product Regulations Group, Health Sciences Authority 04:45 AM Dec 16, 2011

I REFER to Dr Huang Shoou Chyuan's letter "HSA should review registration process for medical devices" (Dec 15).

Medical devices have become increasingly important in the delivery of good healthcare. The regulatory requirements for medical devices were introduced to ensure that safe, efficacious and good quality devices are used here for the benefit of patients.

The Health Sciences Authority (HSA) has implemented a regulatory framework based on principles endorsed by the Global Harmonisation Task Force, a global association of medical device regulators and industry representatives.

The framework ensures that the level of regulation is proportional to the degree of risk and benefit in using a medical device.

More complex devices, such as sophisticated diagnostic imaging equipment or cardiac stents, are subject to tighter regulation and scrutiny than simpler devices such as contact lenses or bandages.

The decisions of our overseas regulatory counterparts and recognised agencies are taken into consideration to minimise duplication of scientific review.

Dr Huang suggested that the HSA operate on a cost-recovery basis. In fact, the registration fees were set in this way to cover the cost of reviewing applications, and are graded according to complexity and device risk.

A small annual retention fee applies, while the registration fee is a one-time fee, valid over a product's life cycle.

We have been mindful of the cost to applicants. To assist in lowering regulatory costs, HSA allows for groupings of multiple devices to be submitted in one pre-market application.

Product extensions of the same device do not require a new application for product registration.

We thank Dr Huang for his comments. Just before the letter was published, HSA met with him to clarify his concerns directly.

HSA will continue to engage the medical device industry and healthcare professionals to fine-tune the regulatory system for the benefit of patients.

nofearSingapore said...

Hi my friends,
I had an opportunity to meet Dr Christina Lim ( who wrote the reply) and I will say that it was a cordial and constructive session. I was asked to give them a specific amount of time to come out with some proposal to solve some of the issues. In the spirit of sincerity, I will wait for these proposals and am ever willing ( together with my doctor friends) to help make the situation better for all stakeholders ( esply patients).I will not comment on Christina's reply.
I wish all at HSA well.
Dr Huang

Anonymous said...

She said that "it is something I would seriously consider if there is a necessity to do so, but I think I will reserve comments at this moment."

wah today i read on channel news asia wat smrt ceo reply when she ask if she would resign.

i feel that she is actually not a very bad ceo afterall. the reply she gave touched me.

because i feel a lot of our mps and ministers cannot even give a better reply than her when responsibilities are concern.

Anonymous said...

mrt can start at 10am tomorrow.

can transport minister have his first meal at 10pm tomorrow??

i feel the previous transport minister should also join in.

Anonymous said...

wah today news said mha clerk eat money. hope govt can check properly to ensure no more eat money case like the sla case as well.

i am afraid are there other eat money cases that still cannot be discover or even never discover.

govt should answer to tax payers.

Anonymous said...

actually i always thought sg govt very strict on corruption so cases of police eat money very rare and police very unlikely to eat money.

but but newapaper said got 10 police, 10!!!!!!!!! wat a number, get bride and got 1 is dsp some more.

wah govt should do more more more.

Anonymous said...

i really hope mp seng can really think carefully before he speak next time. if not should just keep quiet.

cause so much misunderstanding to singaporeans and need to give so much explaination by so many parties even by a minister.

hope tax payer money next time no need waste again.

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