Re: ISO 13485:2016 Pre-Release News and Discussion
The point regarding the use of ISO 13485 for distributors is increasingly important. The Asian Harmonization Working Party are developing a guidance document on Good Distribution Practices, which is aligned with ISO 13485.
What many "Developed" countries (especially here in the USA) fail to understand, is that most medical devices traded within a developing country are introduced to the market through local distributors, and not through the original manufacturer. For example, I collected statistics from Health Science Authority of Singapore, and here are some interesting facts.
There are more than 800 distributors of medical devices in Singapore.
There are 130 registered medical device manufacturers in Singapore
There are 71 registered medical devices firms in Singapore, registered with the US FDA. Almost half do not sell into the USA at all!
Most developing countries trade medical devices regionally or locally and do not sell to the US or Europe! In none English speaking countries like Thailand only 20% of the manufacturers are registered to sell into the USA. Singapore has more than 50% selling to the USA, but English is their first language.
The point is, there are significant regional and local medical device trade concerns outside of the US and European borders that are driving AHWP regulators to create their own guidance for their own purposes. Part of this is to regulate distributors more strictly. IMDRF guidance is not always a good fit, and could actually hurt regional local medical device access, or neglect to address a specific healthcare protection areas of concern to developing nations.
Since ISO and IMDRF seem to shape things more around multinational trade concerns, they neglect local and regional issues that are critical to the other 150 nation's outside the IMDRF block.
What surprised me was the very large number of distributors to manufacturer ratio, but it makes perfect sense. Hospitals in developing nations need lots of devices, and usually only a fraction of 1% are manufactured locally. Australia imports 98% of their products. Distributors play a major role as liaison for foreign imports in smaller economies. This is why AHWP regulators believe Distributors need "GDPs" (which are now based on ISO 13485 criteria).
It is clear that ISO 13485 will increasingly be used by distributors, especially abroad, where regulators will adopt the AHWP guidance. AHWP includes 23 nations covering far more citizens on earth than all the IMDRF members combined! So yes, distributors will not only be expected to be using ISO 13485 in the future, if they do not, they may fail a GDP inspection and suffer consequences from the local regulatory authorities.
I do however believe the third party certification to ISO 13485 will remain voluntary for them, but the requirements will still have to be met under AHWP GDP, as they are transferred to national laws. Singapore already has a legal GDP regulation.
Hello! A small question need your kindly help.
