SBS - The Best Value in QMS software

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
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
shimonv Can you submit a traditional application for a class I device? Other US Medical Device Regulations 7
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
M Issues with leakage current testing for a CLASS II device since no PE and FE is present IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Med Device Class for a Service Organization ISO 13485:2016 - Medical Device Quality Management Systems 2
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 3
K Technical file for MHRA - looking for assistance with self declaration Class I device CE Marking (Conformité Européene) / CB Scheme 8
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 8
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
G Voluntary Class I Device Filing Other US Medical Device Regulations 4
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
D Can a diagnostic device be class I? EU Medical Device Regulations 1
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 8
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
K Doubt on insulation class of a device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8

Similar threads

Top Bottom