Dear All,
i'm new here and hope to be in the right place.
I have few questions and hope you can help me about.
- Is an eye drops classified as medical device in China ?
- I have spoken with a pharma company in China which is producing an eye drop for an overseas manufacturer. They told me that they are GMP but not for the specific eye drops they are producing. What they mean ? Is this legal ?
- Does the factory need to produce such opthalmic liquid under aseptic conditions?
- They told me that the final aseptic filling is made by the customer. They send it in bulk. In my opinion, also if they do not process the final filling , they are producing a Medical Device. Right or wrong ?
- I haven't find any evidence of Iso13485 or GMP for medical devices. To what regulatories they should be compliant ?
Many thhanks
DODODO
i'm new here and hope to be in the right place.
I have few questions and hope you can help me about.
- Is an eye drops classified as medical device in China ?
- I have spoken with a pharma company in China which is producing an eye drop for an overseas manufacturer. They told me that they are GMP but not for the specific eye drops they are producing. What they mean ? Is this legal ?
- Does the factory need to produce such opthalmic liquid under aseptic conditions?
- They told me that the final aseptic filling is made by the customer. They send it in bulk. In my opinion, also if they do not process the final filling , they are producing a Medical Device. Right or wrong ?
- I haven't find any evidence of Iso13485 or GMP for medical devices. To what regulatories they should be compliant ?
Many thhanks
DODODO