Class A Device Registration in Singapore - Disclosure of Manufacturing Sites

M

Mor628

#1
Hi guys,

To register my Class 1 CE marked medical device in Singapore, do I need to disclose the manufacturing sites?
 
Elsmar Forum Sponsor
S

sweetasheaven

#2
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.
 
M

Mor628

#3
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?
 
S

sweetasheaven

#4
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?
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.
 

Attachments

J

jon.loo

#7
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 :notme:

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.
 
Thread starter Similar threads Forum Replies Date
K Class I Medical Device Registration EU Medical Device Regulations 11
P UDI Registration - Class II Medical Device Software Other US Medical Device Regulations 11
Q South Africa Class I Medical Device Accessory Registration Other Medical Device Regulations World-Wide 1
N Registration of Class I Medical Device in UK EU Medical Device Regulations 2
M Myanmar: Class I/II Medical Device Registration Requirements Other Medical Device Regulations World-Wide 1
M Portugal Class I Medical Device Registration of device made in Italy EU Medical Device Regulations 1
M Spain Class I Medical Device Registration EU Medical Device Regulations 14
W Mauritius Class IIA Medical Device Registration Requirements Other Medical Device Regulations World-Wide 3
B Sri Lanka Class IIb Medical Device Registration Other Medical Device Regulations World-Wide 4
B Singapore Class C Device Registration - Time & Cost? Other Medical Device Regulations World-Wide 3
F Class III Medical Device (Contact Lenses) Registration Timescale in Japan Japan Medical Device Regulations 4
B Bangladesh Class IIA Medical Device MDD Registration Requirements Other Medical Device Regulations World-Wide 6
E Special Class III Medical Device registration requirements in Germany and France EU Medical Device Regulations 2
E Registration & Listing of a Dental Device - Class Enforcement Descretion 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D Class I Medical Device Registration (STED) requirements in China China Medical Device Regulations 1
D Registration of Class IV Device -Clinical Data and ISO Certificate Canada Medical Device Regulations 3
I Medical Device Registration Process in Italy - Class I and Class II Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 2
M Class III Medical Device Registration in Russia Other Medical Device Regulations World-Wide 6
V Class III Device CE Mark with ISO 9001 Registration? EU Medical Device Regulations 4
B 510k exempt Class I Medical Device - Confusion during the facility registration US Food and Drug Administration (FDA) 3
L Class II Electrical Medical Device Registration Requirements in Costa Rica Other Medical Device Regulations World-Wide 2
R Class III Medical Device with CE Mark - UK Registration Process EU Medical Device Regulations 6
M Medical Device Class II Registration 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J CE Marking a CE marked Class I Medical Device - To aid approval/registration in China EU Medical Device Regulations 7
S Class III Medical Device Registration and Requirements in Iraq Other Medical Device Related Standards 9
T Health Canada Registration - New Class II Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 3
J Class III Medical Device with CE Mark Approval - India Registration Process ISO 13485:2016 - Medical Device Quality Management Systems 10
chris1price What Class 1 Medical Device Registration is required to sell in Poland EU Medical Device Regulations 3
S NCR under MDD - No documented procedure for class I device registration mechanism ISO 13485:2016 - Medical Device Quality Management Systems 2
B Post-Market Surveillance Requirements for Canada - class IIa/IIb device Canada Medical Device Regulations 1
N Direct Part Marking of the "CE" symbol- Class I Device EU Medical Device Regulations 1
F Philippines: Old Certificate of exemption for Class B device and new LTO. How to proceed? Other Medical Device Regulations World-Wide 0
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
C Legacy device under Class A sterile devices EU Medical Device Regulations 0
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
N FDA class 2 Device QS Requirements US Food and Drug Administration (FDA) 2
S BASIC UDI-DI for a class IIa device marketed in a Procedure kit EU Medical Device Regulations 1
Q Class I Medical Device with measuring function (UK MDR 2002 / MDD) UK Medical Device Regulations 3
R Class II Active Medical Device SYSTEMS and COMPONENTS Canada Medical Device Regulations 2
S Drawing Requirements for Catalog Items (Class II Medical Device) US Food and Drug Administration (FDA) 3
H Mapping QMS+business processes in a medical device with class I and IIa+b Process Maps, Process Mapping and Turtle Diagrams 3
D Class III license: Add new device to the license system Canada Medical Device Regulations 1
R Is "SAFE" permitted in class 1 medical device marketing claims? US Medical Device Regulations 1
ChrisM Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
S Reintroduce packaging component/med device from white room back to class 7 clean room Manufacturing and Related Processes 1
T Class III device and shelf life data requirements US Medical Device Regulations 7
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 2
CharlieUK EU representative details on Class I device CE Marking (Conformité Européene) / CB Scheme 3
A Class 1 medical device - Thailand Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom