M
Mor628
Hi guys,
To register my Class 1 CE marked medical device in Singapore, do I need to disclose the manufacturing sites?
To register my Class 1 CE marked medical device in Singapore, do I need to disclose the manufacturing sites?
Class A Device Registration in Singapore - Disclosure of Manufacturing Sites
S
sweetasheaven
Re: Class A Device Registration in Singapore
Is your device a sterile, single use or ? For certain Class 1 devices, no registration is required and you just require the HS Code to clear custom but the company importing the device must have a certified QMS system by the local authority.
Is your device a sterile, single use or ? For certain Class 1 devices, no registration is required and you just require the HS Code to clear custom but the company importing the device must have a certified QMS system by the local authority.
M
Mor628
Re: Class A Device Registration in Singapore
Non-sterile, single use. Its trays and bowls made from paper pulp material.
So no registration? Hmmm, I wonder why the Singapore company requested it. How can I find the HS codes?
Non-sterile, single use. Its trays and bowls made from paper pulp material.
So no registration? Hmmm, I wonder why the Singapore company requested it. How can I find the HS codes?
S
sweetasheaven
Re: Class A Device Registration in Singapore
I am not sure what kind of trays and bowls your device belongs to? But for Class A, there is usually a specific list that states what is required to be registered and not registered.
you can find in the guideline here.
I am not sure what kind of trays and bowls your device belongs to? But for Class A, there is usually a specific list that states what is required to be registered and not registered.
you can find in the guideline here.
M
Mor628
Re: Class A Device Registration in Singapore
Thanks so much! Heaps helpful
Thanks so much! Heaps helpful
S
sweetasheaven
Re: Class A Device Registration in Singapore
No problem. Good luck!
No problem. Good luck!
J
jon.loo
Hi All,
Please note that the guidance document GN-22 had been updated to 6.2. You can find the most up-to-date guidances at their website.
You will be able to see that they had removed the HS codes from the guidance. That be because HS codes are determined by the Customs Authority and not the Medical Device regulating authority. Following the list in the original guidance may not be 100% accurate, but it is definitely a good reference
It is also important to note that the list is only a suggestion and it all comes down to whether you product is classified as a Class A device that is non-sterile according to Singapore Medical Device Regulations.
To add onto what Sweetasheaven said, the importer will require an Importer licence from the local Authority for importing. The list of Class A non-sterile medical devices must be declared to the Authority as part of the importer licence.
Please note that the guidance document GN-22 had been updated to 6.2. You can find the most up-to-date guidances at their website.
You will be able to see that they had removed the HS codes from the guidance. That be because HS codes are determined by the Customs Authority and not the Medical Device regulating authority. Following the list in the original guidance may not be 100% accurate, but it is definitely a good reference
It is also important to note that the list is only a suggestion and it all comes down to whether you product is classified as a Class A device that is non-sterile according to Singapore Medical Device Regulations.
To add onto what Sweetasheaven said, the importer will require an Importer licence from the local Authority for importing. The list of Class A non-sterile medical devices must be declared to the Authority as part of the importer licence.