Regulatory Open Forum

Hi All.

I hope everyone is keeping safe. 

could anyone share their experience for submitting a device for Regulatory Clearance in Singapore? From what I have read, there are three routes. Immediate, Expedited and Abridged and this is determined on whether you have received clearance in a reference market, e.g. USA, Europe etc.

Has anyone submitted to Singapore? Is it quite straight forward if you have received clearance in a reference market? What kind of timescales, problems did you encounter?

I am sure people will have differing experiences but I would like to get an understanding of what is involved.

Thanks

James

Hi All.

I hope everyone is keeping safe.

could anyone share their experience for submitting a device for Regulatory Clearance in Singapore? From what I have read, there are three routes. Immediate, Expedited and Abridged and this is determined on whether you have received clearance in a reference market, e.g. USA, Europe etc.

Has anyone submitted to Singapore? Is it quite straight forward if you have received clearance in a reference market? What kind of timescales, problems did you encounter?

I am sure people will have differing experiences but I would like to get an understanding of what is involved.

Thanks

James

Hi All.

I hope everyone is keeping safe.

could anyone share their experience for submitting a device for Regulatory Clearance in Singapore? From what I have read, there are three routes. Immediate, Expedited and Abridged and this is determined on whether you have received clearance in a reference market, e.g. USA, Europe etc.

Has anyone submitted to Singapore? Is it quite straight forward if you have received clearance in a reference market? What kind of timescales, problems did you encounter?

I am sure people will have differing experiences but I would like to get an understanding of what is involved.

Thanks

James

Depending on the types of foreign certificates, such as CE-marking and FDA clearance, various registration routes apply. If the product is class 1(510k exempt),510K exemption cannot be counted as 1 agency approval for Singapore because the Singapore Health Sciences Authority (HSA) rely on US FDA formal review (510K or PMA) to justify a shorter review period.

Based on the 'abridged route', the processing of the application is as follows: Prepare documentation for submission to submit the file to HAS in collaboration with local partner à Screening of application by HSA à Evaluation of the application by HSA à Regulatory decision and listing for successful registration.

The evaluation is based on the data set submitted by the applicant. The estimated turnaround time from the authorities is estimated at 5-6 months. These commence from the date of receipt of the application to HSA.

For an 'immediate route', the device must be already registered in Canada or if the product must be sold in the EU for at least 3 years. There is no turnaround time for the 'immediate route' as your registration takes place upon submission. The below set of documents are required for immediate route

• Sales report (last 3 years),. Any other proof of marketing history that you consider relevant.
• IFU and technical file
• Device description if not mentioned in one of the above points.
• Product brochure
• Label
• Manufacturer information (site's name and address)
• CE certificate
• Quality Management Certificate such as ISO 13485
• Declaration of no adverse events or safety issues.

Please note that a local partner (based in Singapore) must be identified prior to submission. He/she will be responsible for

• Becoming the license holder (also known as a registrant in Singapore)
• Registration of product
• Appointing client importer/ distributor

Note: you can also appoint the importer/distributor independently. 

The importer/ distributor should already be a qualified entity (with Good Distribution Practice certification and with a valid importer/ wholesaler license from the Singapore authority HSA).

Hi All.

I hope everyone is keeping safe.

could anyone share their experience for submitting a device for Regulatory Clearance in Singapore? From what I have read, there are three routes. Immediate, Expedited and Abridged and this is determined on whether you have received clearance in a reference market, e.g. USA, Europe etc.

Has anyone submitted to Singapore? Is it quite straight forward if you have received clearance in a reference market? What kind of timescales, problems did you encounter?

I am sure people will have differing experiences but I would like to get an understanding of what is involved.

Thanks

James

Depending on the types of foreign certificates, such as CE-marking and FDA clearance, various registration routes apply. If the product is class 1(510k exempt),510K exemption cannot be counted as 1 agency approval for Singapore because the Singapore Health Sciences Authority (HSA) rely on US FDA formal review (510K or PMA) to justify a shorter review period.

Based on the 'abridged route', the processing of the application is as follows: Prepare documentation for submission to submit the file to HAS in collaboration with local partner à Screening of application by HSA à Evaluation of the application by HSA à Regulatory decision and listing for successful registration.

The evaluation is based on the data set submitted by the applicant. The estimated turnaround time from the authorities is estimated at 5-6 months. These commence from the date of receipt of the application to HSA.

For an 'immediate route', the device must be already registered in Canada or if the product must be sold in the EU for at least 3 years. There is no turnaround time for the 'immediate route' as your registration takes place upon submission. The below set of documents are required for immediate route

• Sales report (last 3 years),. Any other proof of marketing history that you consider relevant.
• IFU and technical file
• Device description if not mentioned in one of the above points.
• Product brochure
• Label
• Manufacturer information (site's name and address)
• CE certificate
• Quality Management Certificate such as ISO 13485
• Declaration of no adverse events or safety issues.

Please note that a local partner (based in Singapore) must be identified prior to submission. He/she will be responsible for

• Becoming the license holder (also known as a registrant in Singapore)
• Registration of product
• Appointing client importer/ distributor

Note: you can also appoint the importer/distributor independently. 

The importer/ distributor should already be a qualified entity (with Good Distribution Practice certification and with a valid importer/ wholesaler license from the Singapore authority HSA).

Hi All.

I hope everyone is keeping safe.

could anyone share their experience for submitting a device for Regulatory Clearance in Singapore? From what I have read, there are three routes. Immediate, Expedited and Abridged and this is determined on whether you have received clearance in a reference market, e.g. USA, Europe etc.

Has anyone submitted to Singapore? Is it quite straight forward if you have received clearance in a reference market? What kind of timescales, problems did you encounter?

I am sure people will have differing experiences but I would like to get an understanding of what is involved.

Thanks

James

Depending on the types of foreign certificates, such as CE-marking and FDA clearance, various registration routes apply. If the product is class 1(510k exempt),510K exemption cannot be counted as 1 agency approval for Singapore because the Singapore Health Sciences Authority (HSA) rely on US FDA formal review (510K or PMA) to justify a shorter review period.

Based on the 'abridged route', the processing of the application is as follows: Prepare documentation for submission to submit the file to HAS in collaboration with local partner à Screening of application by HSA à Evaluation of the application by HSA à Regulatory decision and listing for successful registration.

The evaluation is based on the data set submitted by the applicant. The estimated turnaround time from the authorities is estimated at 5-6 months. These commence from the date of receipt of the application to HSA.

For an 'immediate route', the device must be already registered in Canada or if the product must be sold in the EU for at least 3 years. There is no turnaround time for the 'immediate route' as your registration takes place upon submission. The below set of documents are required for immediate route

• Sales report (last 3 years),. Any other proof of marketing history that you consider relevant.
• IFU and technical file
• Device description if not mentioned in one of the above points.
• Product brochure
• Label
• Manufacturer information (site's name and address)
• CE certificate
• Quality Management Certificate such as ISO 13485
• Declaration of no adverse events or safety issues.

Please note that a local partner (based in Singapore) must be identified prior to submission. He/she will be responsible for

• Becoming the license holder (also known as a registrant in Singapore)
• Registration of product
• Appointing client importer/ distributor

Note: you can also appoint the importer/distributor independently. 

The importer/ distributor should already be a qualified entity (with Good Distribution Practice certification and with a valid importer/ wholesaler license from the Singapore authority HSA).

Hi All.

I hope everyone is keeping safe.

could anyone share their experience for submitting a device for Regulatory Clearance in Singapore? From what I have read, there are three routes. Immediate, Expedited and Abridged and this is determined on whether you have received clearance in a reference market, e.g. USA, Europe etc.

Has anyone submitted to Singapore? Is it quite straight forward if you have received clearance in a reference market? What kind of timescales, problems did you encounter?

I am sure people will have differing experiences but I would like to get an understanding of what is involved.

Thanks

James

Hi All.

I hope everyone is keeping safe.

could anyone share their experience for submitting a device for Regulatory Clearance in Singapore? From what I have read, there are three routes. Immediate, Expedited and Abridged and this is determined on whether you have received clearance in a reference market, e.g. USA, Europe etc.

Has anyone submitted to Singapore? Is it quite straight forward if you have received clearance in a reference market? What kind of timescales, problems did you encounter?

I am sure people will have differing experiences but I would like to get an understanding of what is involved.

Thanks

James