The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > Other Medical Device Regulations World-Wide
Forum Username


Search the Elsmar Cove
Custom Search
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Sponsor Links





Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's
International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
regulations and regulatory requirements, singapore, medical device company or industry, medical devices (general)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 27th April 2010, 01:11 AM
somashekar's Avatar
somashekar somashekar is offline
Cross Forum Moderator

 
Registration Date: Mar 2008
Location: Bangalore city, INDIA
 
Posts: 4,369
Thanks Given to Others: 1,417
Thanked 2,267 Times in 1,600 Posts
Blog Entries: 2
Karma Power: 490
Karma: 14582
somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.
somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.somashekar is appreciated, and has over 1700 Karma points.
Send a message via Yahoo to somashekar
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, 82 views)

__________________

Best Regards...
Somashekar BV, INDIA

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

Sponsored Links
  #2  
Old 27th April 2010, 11:15 AM
Ronen E Ronen E is online now
Glad to help, if I can

 
Registration Date: Mar 2010
Location: Western Australia
 
Posts: 1,803
Thanks Given to Others: 1,611
Thanked 1,032 Times in 724 Posts
Karma Power: 215
Karma: 9000
Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.
Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.Ronen E is appreciated, and has over 1700 Karma points.
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!
Sponsored Links

  #3  
Old 30th April 2010, 11:26 AM
zhang126 zhang126 is offline
Involved in Discussions

 
Registration Date: Mar 2007
Location: Stockholm, Sweden
 
Posts: 62
Thanks Given to Others: 25
Thanked 29 Times in 13 Posts
Karma Power: 35
Karma: 150
zhang126 is appreciated, and has over 100 Karma points.zhang126 is appreciated, and has over 100 Karma points.
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!
  #4  
Old 1st May 2010, 03:45 AM
bio_subbu's Avatar
bio_subbu bio_subbu is offline
S. Subramanian

 
Registration Date: Aug 2007
Location: India
 
Posts: 581
Thanks Given to Others: 210
Thanked 884 Times in 365 Posts
Karma Power: 96
Karma: 5205
bio_subbu is appreciated, and has over 1700 Karma points.
bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.bio_subbu is appreciated, and has over 1700 Karma points.
Send a message via Skype™ to bio_subbu
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, 54 views)
Thank You to bio_subbu for your informative Post and/or Attachment!
  #5  
Old 15th September 2011, 05:13 AM
Rodbz Rodbz is offline
Shy Poster (1 to 5 Posts)

 
Registration Date: Sep 2011
 
Posts: 1
Thanks Given to Others: 0
Thanked 0 Times in 0 Posts
Karma Power: 11
Karma: 10
Rodbz has less than 100 Karma points so far.
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.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > Other Medical Device Regulations World-Wide

Do you find this discussion thread helpful and informational?


Bookmarks


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Regulation on Bioresorbable Oil Residue Level on Medical Device Dudes US Medical Devices (21 CFR part 820) 3 28th May 2013 05:37 AM
Singapore Medical Device Registration & Authorised Representative Adele Other Medical Device Regulations World-Wide 8 20th September 2011 12:15 PM
Non-Invasive Medical Device Machines - Singapore Registration crownether Other Medical Device and Orthopedic Related Topics 4 28th July 2010 01:06 AM
Medical Device Regulatory Guidelines – Singapore's Health Sciences Authority (HSA) bio_subbu Other Medical Device Regulations World-Wide 1 13th September 2009 09:21 AM
Medical Device Regulations - Importing to Singapore - Orthodontic brackets dragmytoe Other Medical Device Regulations World-Wide 5 31st July 2009 11:53 AM



The time now is 04:58 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


   


Marc Timothy Smith - Elsmar.com
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272