Non-Invasive Medical Device Machines - Singapore Registration

C

crownether

Does anyone know how the Singapore registration procedure for Non-Invasive Systems or Machines? Do they classify it as Medical Device in Singapore?
 
Y

yana prus

Re: Non-Invasive Machines Singapore Registration

You can see the definition of the medical device in Singapore here:

http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/medical_devices/Overview.html

Medical devices are classified into 4 risk classes, when A is the lowest risk and D is the highest risk. The classification rules are adopted from the guidance developed by the GHTF.

Currently, only contact lens care products, radiation emitting devices and condoms come under statutory control through certain provisions in the Medicines Act and Radiation Protection Act. Recently voluntary registration deadline in Singapore was extended from 1 May to 1 Aug.



Current post marketing obligations of the medical device dealers are:
  • Report adverse events to HSA within stipulated time frame
  • Notify HSA prior to the initiation of a product recall
  • Keep records of complaints and product distribution
The false or misleading advertisements and promotions of medical devices will be prohibited. HSA can direct an advertiser to publish a “corrective advertisement” for any false or misleading advertisements.

Starting from 1 Aug 2010 onwards, unlicensed manufacturers, importers and wholesalers cannot deal with medical devices.

Starting from 1 Aug 2010, supply of unregistered Class C and D medical devices, that are not on the Transition List, is prohibited.

From 1 Aug 2011, supply of unregistered and un-exempted Class A medical devices and unregistered class B devices is prohibited.
 
C

crownether

Re: Non-Invasive Machines Singapore Registration

Hi yana! Thank you for the information. Would you know any consulting agency that can help us get the license for medical device?
 

Ronen E

Problem Solver
Moderator
Re: Non-Invasive Machines Singapore Registration

Hi yana! Thank you for the information. Would you know any consulting agency that can help us get the license for medical device?

Hi there,

I'm located only 4 hours flight away from you ;) and I do some freelancing on medical devices regulatory affairs. I am sending you my contact details on a private message.

Cheers,
Ronen.
 

bio_subbu

Super Moderator
Does anyone know how the Singapore registration procedure for Non-Invasive Systems or Machines? Do they classify it as Medical Device in Singapore?

I would suggest you to verify whether your product fall under the Definition of a medical device. If the product falls under the definition of a medical device and is not listed in GN-22 Guidance to the List of Medical Devices Exempted from Product Registration, you are required to register the product with the Medical Device Branch of HSA.

Upon determining the above, please verify the risk classification of the medical device with reference to below HSA guidance document, as applicable,

GN-13 Guidance on the Risk Classification of General Medical Devices and

GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices

The guidance document are available at below HSA link:

http://www.hsa.gov.sg/publish/hsapo...ion/medical_devices/regulatory_guidances.html

I would also like to inform that all medical devices need to be registered with HSA before they are allowed to be supplied. The time line for mandatory registration will be dependent on the risk classes. The exceptions will be products that are exempted from registration as stipulated on slides 16 and 17 of the appended slides from the Industry Briefing on 26 April 2010, which available at http://www.hsa.gov.sg/publish/hsapo...ation/medical_devices/regulatory_updates.html

For information regarding the fees and charges for product registration of medical devices and dealers’ license are available here.

Regards
S. Subramaniam
 
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