actually our products are mainly diagnostics kit and equipment, is ISO 13485 applicable to us? or GDPMDS? We are based in malaysia...so which do you think is more relevant for our industry, anyone in this industry certified? My customer is insisting for us to get one
Hi,
Once again, the starting point is the territory you sell your products into, e.g. Malaysia, Singapore, Australia, China, other...? This will determine the regulatory system(s) and rules you would be subject to, including a definition of what would or would not be considered a medical device (i.e. are the products you're selling considered medical devices or not, in the relevant territories).
Some more / other requirements may apply to your operations under the Malaysian legislation (regardless of where you sell the products) simply because you are located there.
Anyway, if your customer insists on you getting a certain certification (be it 13485, GDPMDS or else), and you are unable to persuade them to waive that requirement, then regardless of regulatory requirements you would have to choose between getting certified or losing this customer...
Cheers,
Ronen.