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Regulatory Affairs Working Party

Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Government publishes review of the Coronavirus Test Device Approvals (CTDA) process

On 29 December, the UK Health Security Agency published their statutory review of the CTDA process. The CTDA process was introduced to ensure that antigen and molecular Covid-19 tests were assessed for performance before being put into the UK market, intending to increase the quality of UK tests. The overarching theme of the review is summarised: “It is clear that…
Natalie Creaney
January 13, 2023
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Affairs Working Party Meeting and Lunch – Friday 9 December 2022

Each year, BIVDA organises a Christmas dinner for members of the Regulatory Affairs Working Party, as well as a charity appeal. This years charity is FareShare, who redistribute surplus food to charities that turn it into meals and provide much needed support to communities in need. Please donate here. The Christmas lunch will be held at Ponti's restaurant which is located just off Oxford…
Natalie Creaney
November 25, 2022
Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA UKCA sub-group

BIVDA previously ran a UKCA sub-group which was an off-shoot of the Regulatory Affairs Working Party. This group hasn’t met recently due to insufficient content. Now that we have slightly more clarity on the UKCA regulations and MHRA have committed to introducing timeline legislation in Spring 2024, we thought this was the opportune time to restart this group. The UKCA…
Ben Kemp
November 3, 2022
Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Affairs Working Party Seminar 2022

On 13 and 14 October, we held our annual Regulatory Affairs Working Party Seminar. This went very well (it wouldn’t be an event without some slight technical issues), with a fantastic turn out. BIVDA would like to thank all of our speakers, the Regulatory Affairs Working Party team, and all of the attendees for making it such a positive event.…
Natalie Creaney
October 21, 2022
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

France Biotech & Eucope Regulatory Survey

France Biotech is conducting a field survey with Eucope. This survey is intended to highlight the difficulties encountered by small and medium-sized companies of Medtech sector to comply with the clinical and regulatory requirements of the MDR. They require more foreign respondents to ensure a significant European representativeness, with a deadline of 11 November 2022. The survey can be accessed…
Ben Kemp
October 14, 2022
Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Regulatory Affairs Working Party Seminar 2022

Next week brings our annual Regulatory Affairs Working Party Seminar, taking place on 13 and 14 October at The Belfry in Birmingham. This event will immediately follow from our joint working party event on the 12 October. Please find the full agenda for the event here. The dress code for the overall seminar is smart-casual. There will also be a…
Ben Kemp
October 7, 2022
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Limited places remaining for the Regulatory Affairs Working Party Seminar

Our annual Regulatory Affairs Working Party Seminar is planned for 13-14 October, and is fast approaching. This event is now almost sold out. Members are encouraged to book as soon as possible if you are interested in attending to prevent disappointment. The latest agenda can be found here. Please note that there are now only rooms available at The Belfry…
Natalie Creaney
September 16, 2022
Export Working PartyExport Working Party ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

Update: Declaring reusable packaging for Great Britain imports and exports

When to submit a safety and security declaration for imports into Great Britain has changed. No new import controls will be introduced in 2022. A new target operating model of border controls will be published in Autumn 2022, with an aim to introduce the new rules by the end of 2023. The full guidance document can be accessed here.
Ben Kemp
September 2, 2022
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