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Medical Device Regulation - Singapore - 1st May 2010


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  Post Number #1  
Old 27th April 2010, 01:11 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,233
Look! Medical Device Regulation - Singapore - 1st May 2010

The mandatory regulation for “Product Registration for all Medical Device” in Singapore being introduce from 1st May 2010.
From 1st May 2010, you will be allowed to Import / Sell only for the products registered with Health Science Authority in Singapore.
The product registration needs to be done with HSA (Health Sciences Authority), their website being www.hsa.gov.sg.
useful link : http://www.hsa.gov.sg/publish/hsapor...guidances.html
{The above info is based on my Singapore contact information. Concerned users may check its implications with authorities}
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf HSA_GN17[1].pdf (352.1 KB, 95 views)

Last edited by somashekar; 27th April 2010 at 03:14 AM.
Thank You to somashekar for your informative Post and/or Attachment!

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  Post Number #2  
Old 27th April 2010, 11:15 AM
Ronen E

 
 
Total Posts: 3,308
Re: Medical Device Regulation - Singapore - 1st May 2010

Quote:
In Reply to Parent Post by somashekar View Post

The mandatory regulation for “Product Registration for all Medical Device” in Singapore being introduce from 1st May 2010.
From 1st May 2010, you will be allowed to Import / Sell only for the products registered with Health Science Authority in Singapore.
The product registration needs to be done with HSA (Health Sciences Authority), their website being www.hsa.gov.sg.
useful link : http://www.hsa.gov.sg/publish/hsapor...guidances.html
{The above info is based on my Singapore contact information. Concerned users may check its implications with authorities}
Hi,

Good reminder.

Please note, however, that registration of low risk (class A) devices will become mandatory only next year (May 2011). All other classes are mandatory beginning 1.5.10.

Also, from 1.5.10 all medical devices manufacturers, impoters and wholesalers in Singapore must be licensed.

Cheers,
Ronen.
Thank You to Ronen E for your informative Post and/or Attachment!
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  Post Number #3  
Old 30th April 2010, 11:26 AM
zhang126

 
 
Total Posts: 62
Re: Medical Device Regulation - Singapore - 1st May 2010

HSA revised the regulatory timeline on April 26. The new timeline is,
From 1 AUGUST 2010
Medical Devices allowed to be supplied in Singapore:
i. Registered Class C & D Medical Devices
ii. Class C & D that are on the T List
iii. ALL Class A & B medical devices (until 31 Jul 2011)
iv. MDs licensed with CRPNS(NEA) (until 31 Jul 2011)
v. Unregistered class C and D MDs (e.g. MDs that are
NOT on the T List) – can ONLY be continued to be
supplied if they have gone through the Authorisation
Routes.
Thank You to zhang126 for your informative Post and/or Attachment!
  Post Number #4  
Old 1st May 2010, 03:45 AM
bio_subbu's Avatar
bio_subbu

 
 
Total Posts: 617
Re: Medical Device Regulation - Singapore - 1st May 2010

Quote:
In Reply to Parent Post by somashekar View Post

The mandatory regulation for “Product Registration for all Medical Device” in Singapore being introduce from 1st May 2010.
From 1st May 2010, you will be allowed to Import / Sell only for the products registered with Health Science Authority in Singapore.
The product registration needs to be done with HSA (Health Sciences Authority), their website being www.hsa.gov.sg.
useful link : http://www.hsa.gov.sg/publish/hsapor...guidances.html
{The above info is based on my Singapore contact information. Concerned users may check its implications with authorities}
Hi Somashekar

Thanks for the update, the detailed information of Phase 3 implementation are available in HSA’s (Singapore Health Sciences Authority) latest slide presentation which available on their website. A copy of presentation can be downloaded from here.

S.Subramaniam
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf MDB Industry Briefing 26 Apr 2010_ Phase3.pdf (247.8 KB, 70 views)
Thank You to bio_subbu for your informative Post and/or Attachment!
  Post Number #5  
Old 15th September 2011, 05:13 AM
Rodbz

 
 
Total Posts: 1
Re: Medical Device Regulation - Singapore - 1st May 2010

Hi,

Going through these Regs, can anyone see if there would be a problem own brand labelling? The definition of 'manufacture' would mean the original manufacturer is included in this definition before we re-badge the product and would therefore need information from the original manufacturer as required in Part VIII, but, I cannot find any reason that an OBL product would not be permitted to register. Any thoughts??

Thanks.
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