Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We have a class IIb implant (non-active), and have ISO 13485 but do not have MDD/MDR. I have been tasked with figuring out the QA/RA pathway to sell in multiple countries outside the US.  I have been going to each country's web pages but sometimes it's like searching a "needle in a haystack" for the requirements and it is also time-intensive.  What is the easiest (and quickest) way to determine what licenses, certifications, in-country requirements, etc. to sell devices with timelines and costs? 

The typical approach is to either

1. Use your established Regulatory Strategy template/process combined with the sufficient expertise in each jurisdiction to prepare and write the Strategy; or
2. Hire an outside expert who can do this for you.

We'd be glad to help.

 

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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 25-Mar-2024 14:19
From: Anonymous Member
Subject: OUS Reg Path Guidance

This message was posted by a user wishing to remain anonymous

We have a class IIb implant (non-active), and have ISO 13485 but do not have MDD/MDR. I have been tasked with figuring out the QA/RA pathway to sell in multiple countries outside the US.  I have been going to each country's web pages but sometimes it's like searching a "needle in a haystack" for the requirements and it is also time-intensive.  What is the easiest (and quickest) way to determine what licenses, certifications, in-country requirements, etc. to sell devices with timelines and costs? 

Hello Anon,

This can be a huge, time-consuming, complex activity because regulations are not the same in every country including classification differences, quality system requirements, registration/certificate renewals, reportability for vigilance/technovigilance.  Many organisation's Regulatory department creates extensive databases to manage this information.  The easiest way is to work with an external entity who has this regulatory intelligence as they usually keep these up to date.  Of course, there are fees or subscriptions for these type of services.  A more complex way is to work with local experts in each country which can also keep you up to date on the requirements or even assist with submissions; these also usually have costs involved.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 25-Mar-2024 16:29
From: Kevin Randall
Subject: OUS Reg Path Guidance

The typical approach is to either

1. Use your established Regulatory Strategy template/process combined with the sufficient expertise in each jurisdiction to prepare and write the Strategy; or
2. Hire an outside expert who can do this for you.

We'd be glad to help.

 

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 25-Mar-2024 14:19
From: Anonymous Member
Subject: OUS Reg Path Guidance

This message was posted by a user wishing to remain anonymous

We have a class IIb implant (non-active), and have ISO 13485 but do not have MDD/MDR. I have been tasked with figuring out the QA/RA pathway to sell in multiple countries outside the US.  I have been going to each country's web pages but sometimes it's like searching a "needle in a haystack" for the requirements and it is also time-intensive.  What is the easiest (and quickest) way to determine what licenses, certifications, in-country requirements, etc. to sell devices with timelines and costs?