Medical Device Regulations - Importing to Singapore - Orthodontic brackets

D

dragmytoe

Our distributer in Singapore is unfamiliar with registering Orthodontic brackets and supplies...Does anyone have insight to the required paperwork and notarization it must go thru? (Importing from the US)
 

Ajit Basrur

Leader
Admin
I agree with Harry - in Singapore, the information is readily available at hand's stretch :)

The Health Sciences Authority website - www.hsa.gov.sg has lots of related info. Additionally, BUYUSA website could provide additional insights.
 

sreenu927

Quite Involved in Discussions
Hi..
Your Importer has to do following in sequence:
1. Open CRIS Administrator account with HSA(www.hsa.gov.sg)
2. The register as a "Registrant".(ACRA business license is reqd)
3. Appoint a 3rd Part Certification body (list is in http://www.sac-accreditation.gov.sg/) to do GDPMDS Certification Audit.
4. After obtaining GDPMDS certificate, prepare the documentation(guidance from HSA website; Site Master File, SOPs-complaint handling, control of docs, control od records, distribution records, traceability, FSCA, handling,storage, training of personnel, records, etc..) and list of devices with its class and submit to HSA via MEDICS account (once u get CRIS user name and pswd, u can be able to access MEDICS).
5. Mention what ever applicable (Importer or Wholesaler).
6. That's all:)

Cheers
Sreenu
 
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