accuracy not good. easy broken. but chiep

Your iPhone also is made in China

China is a really big place. 30 million in ShenZen alone. Not sure the approach to the question is productive. What I'd like to know is how do you find quality mfg. in China? BTW iPhones are assembled in China components come from a number of countries.

Dr. Patrick Druggan I moved one component there from the UK. The product was as good as the UK manufactured one once you got over some glitches.

Like anywhere else, it's important to screen and know your supplier. Develop the trust and have the proper ongoing evaluations in place.

There are many of the top medical companies whose medical devices are made in China....I know I have sold them!

Samson Wesley Abboy mindray- excellent ultrasound, anaesthetic machine and monitors. no problems. bought a foryou negative pressure wound therapy device with foam dressing. worked well but didn't feel as good as the kci one. the yellow part for tubing kept getting unstuck and the cannister could be opened spilling the exudate.

In no way could I condone buying anything from China. After what they have done to this country I avoid their products whenever I can.

Mateusz Pawelec For sure it also depends on the type / class of a medical device. There are products which quality does not differ from European standards, even better .
In fact, there is not much “100% made-in-china medical products” on the European market. However If we look at the European/American products , usually we goanna find some components from Asia.
So it depends on "what" you are looking for: components as a manufacturer or the product as a distributor / importer.

Very much depends WHO is making the products in China! For example, the ITL group has a wholly owned subsidiary company in China called IES - they are fully controlled and run by the UK business, operate an ISO 9001 and ISO 13485 quality system (and are audited by a UK notified body - BSI!) and on top of that follows all the same procedures and systems as we do here in the UK. Personally I think there is no problem with using Chinese manufacturing - you might not save on component costs but you will probably save on labour. You just need the right partner company to help get you there!!

Cheap, long time transport, quality sometimes questionable, information on boxes and products sometimes inaccurate or doubtfull. It sure depends on the kind of medical devices and if the producer meets the quality standards.

I agree with what Tom Ackrill is saying. The bottom line is that medical device companies are responsible for the quality of their products, no matter who manufactures it or what it is manufactures. An medical device companies need a supplier quality process that is ready to audit at the level needed based on the type of device. Where manufacturing happens is a business decision, but going to another country, needs to take into consideration the cost of proper monitoring, supplier management, and audits both by notified bodies and by the company contracting for the builds. That is the essence of Supplier Management and on-site audit costs need to be part of the business and quality decision.

Some great comments here.
Agree with John (know and trust your supplier), with Mateusz (depends on the complexity), with Tom (depends on the specific manufacturing facility and business your partners).
I will add that in addition to the technical and regulatory expertise, the final outcome also depends on the total soft skill set brought together by all people (buyer and manufacturing facility) supporting the supply chain. Being able to working across time zones, languages and cultures must be a part of that skill set.

Wes Moncus I agree with Tom Ackrill. It does depend on who. I would start with a company that has a mature quality system and ISO 13485. I would rigorously qualify a supplier, especially if they plan to make implantable devices such as a prosthetic heart valve. I would also rigorously qualify 2nd and 3rd tier suppliers, since my experience is that their quality systems are less mature. The other concern is the 6-8 week supply chain, from Shanghai or Shenzhen, and longer if you are manufacturing inland.

Ee Bin Liew The main issue is the wide spectrum with regards to product quality (could range from bad to great), and consistency(one day great, another day not-sure). This comes about with the large volumes of products that's churned out of the world's largest factory, shipped all over the world.

in China, paperwork is paperwork. I'd recommend to have processes to verify the paperwork (it's a huge challenge!) Culturally, networking and especially empathy goes a long way and it's rewarded with trust.

Cheers,
Ee Bin

Robert Betz Be wery wery careful! Quality is not consistent...

Art Pichierri I've moved companies to Mexico and currently have contract manufacturing in China. I prefer China. In either place, one really needs to adhere to parent QC and insist they are duplicated. China duplicates very well. Cultural differences play an enormous part. I have had horrendous experience in China and for the past 10 years I have had superior results in quality, service and attention to detail in China. Finding the right fit made the difference for me. Not so much in Mexico. I have found that the individuals I personally deal with at my facility in China have tremendous personal dedication to producing my products, however, I established this from day one and have been highly visual to each player in the chain of the production process. This has been 'key' for us.

Shyamal Roy as long as the device meets functional and regulatory requirement, it doesn't matter . However the credential of the firm must be checked

Andrew Kyle I would not willingly risk my life on a device that was not managed and controlled by a credible company from the USA or EU or Britain They cannot keep their water or food pure - why would medical products be different?

For me there is no question. Chinese business practices have always been questionable at best. Their manufacturability, reliability and quality have always been suspect. For these reasons, I would not trust anyone's health and well being to any medical devices manufactured in China.

I read on this thread "It depends on who" the supplier is, it depends on the class. I say no it doesn't. If you use Medical Device products made in China you are increasing the risk to your patient or yourself unnecessarily.

10 years ago, a large population of orthopedic surgeons rejected the idea to use "central europe medical devices". The same goes now for asian devices (previously there was none).
China produces nearly all computers and smartphones. So the short term quality is there. But with medical devices, you are looking for a very long term high quality, plus minimum risk for patients, surgeons, hospitals and your business. If anything goes wrong, they will all sue you. Your odds are simple to compute.

Quality control and patent protection are the two biggest issues we encountered in the past. Unfortunately, there is no compromise that you can take when talking quality medical device, by the way this is not only relevant for China. I am certain with strict adherence to process and procedure (that need to be controlled permanently, as I have witnessed in another Industry is sometimes taken very light) it should be feasible to produce there as well.

I have two suppliers from China, and I can say that I have not had any problems with their products

Dr. Patrick Druggan These are ISO 13485 and FDA accredited facilities. China has had recalls of materials made in the West too. I had a good working relationship with my Chinese suppliers and used consumer-producer riskmodelling to ensure that the risk of failure in the hands of my customers was <1 x10^-6 in accordance with Table D4 of ISO14971. I had a good relationship with them, but I was regularly in China, and spent time improving my communication with my suppliers. The problem is two way. The regulatory and quality environment is developing in China, but you have responsibility for your own products - you can't heave it over the fence.

some product of China made is really good such as contec medical systems product

Julie Omohundro Like medical devices made anywhere, they are as good as the buyer assures them to be. I think the real question is how much will it cost to assure the quality?

Interesting discussion, I would like to know what about American Manufacturers that manufacture their product in China and export them all over the world "American Products made in China" would you trust that.

Julie Omohundro CEB, the same principle applies, I think. It depends on how well the American manufacturer assures the quality of the devices they sell, whether they make them in-house or use a contract manufacturer in the US, China, or wherever.

Reginaldo Hermanson China is a big country and a complex culture. We can find everything since trash to rocket science. We just need to pay attention and select devices according to our needs. (And always keep your eyes open...)

China at times make quality and times make su-standard devices. You have to tell them that we need quality and they will make it for you.

This is really funny. I've been in this business, selling Medical Devices (in China) for many years. Most hospitals do not even care to discuss the purchase of Medical Devices "Made in China." They only want the best and they know that "Made in China" is far Inferior so they are "NOT INTERESTED!" Nine out of Ten of my sales are Foreign Made Medical Devices. Go Figure!

Dr. Patrick Druggan You might want rephrase the question around the quality of devices made in China. The current question is about personal opinion and this may be biased.

Ricardo Faria Probably the high quality produções made in China will cost you the same as the European or American ones. The point is far from quality but are you buying something that has local support (technical as an example) or do you need to call to China? How much does it cost a lack of maintenance or those products. Medical devices or any other with similar needs? How much does it cost if your device is not working?

I have worked for and with a Chinese company and found them to be highly dynamic and open to new ideas. Equally they are fast to make design changes and in my view will soon surpas the American healthcare companies.

The quality issues associated with made in China no longer exists- they demand high quality.

Nicolas Gay I think there is behaviour evolution in China in order to improve their image around the world and also for themselves. I don't know the real quality of their medical devices, but I am quite sure that it will be more and more better.

Julie Omohundro Is there some way to know whether a device was "made in China" if the "manufacturer" is not located in China? I don't think contract manufacturers are listed on the label?

I think we should only sell them in Asia.

China made medical devices can be very competitive and advanced too. Just be aware and make sure they could provide you the proper after sales technical support, which you will need to endure throughout the lifespan of the devices.

Shyamal Roy Darryl, Selling device in Asia is not easy , just because they are made in China and low cost. Japan regulatory is strong as US or EU.
IF a device doesn't deliver , no body will use it and its cost doesn't matter.

I have over the years bought medical devices both directly from Chinese reps and also from their local reps in Nigeria. They have not performed badly, especially considering their cost. However a constant problem is insufficient or poor user-instructions. All said and done, their continued presence on the equipment arena is appreciated.

Alisa Buchman Nearly every device in China has a CE mark on it. When I required how can it be they said that CE means China Export. That's my opinion on this issue