Publication
New rules for MDEL holders: Health Canada’s terms and conditions authority
Amendments to the Medical Devices Regulations affecting the regulatory framework for medical device establishment licences (MDEL) are now in effect.
United States | Publication | January 2024
On January 22, 2024, the Federal Trade Commission (FTC) announced increased reporting thresholds under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act).
These reporting thresholds are revised annually based on changes in the US gross national product. The increases will apply to all transactions that close after the effective date, which will be 30 days after publication of the changes in the Federal Register, estimated to be February 21, 2024.
Most importantly, the minimum "size-of-transaction" threshold will be increased from US$111.4m to US$119.5m. Acquisitions below this threshold will not be reportable.
Threshold | 2024 Adjusted threshold |
Minimum size-of-transaction | US$119.5m |
Size-of-persons test | US$23.9m and US$239m |
Size-of-transaction above which size-of-persons test does not apply |
US$478m |
The adjustments also apply to certain other HSR Act thresholds and exemptions, such as the exemptions for acquisitions of foreign assets and voting securities.
Additionally, the FTC adjusted the filing fees applicable to transactions for the first time since the new filing fee framework was announced in 2023. Filing fees have been adjusted based on changes in the Consumer Price Index:
2024 Size of transaction | Filing fee |
At least $119.5 but less than US$173.3m | US$30,000 |
At least $173.3 but less than US$536.6 million | US$105,000 |
At least $536.6m but less than US$1.073bn |
US$260,000 |
At least $1.073bn but less than US$2.146bn | US$415,000 |
At least $2.146bn but less than US$5.365bn | US$830,000 |
US$5.465bn or more | US$2,335,000 |
Even if a transaction is reportable based on the above thresholds, it may qualify for an HSR Act exemption. Complex rules apply to the valuation and exemptions under the HSR Act, and you should consult a lawyer experienced in HSR matters to determine whether a transaction is reportable.
The new thresholds will remain in effect until the next annual adjustment, expected in January or February 2025.
Publication
Amendments to the Medical Devices Regulations affecting the regulatory framework for medical device establishment licences (MDEL) are now in effect.
Publication
Early January is a good time to take stock of workplace law developments that arose in 2024, and how those developments may evolve in 2025.
Publication
As you prepare for your next AGM, stay up-to-date on key developments in Canadian corporate and securities legislation, corporate governance guidance and institutional shareholder proxy voting guidelines that may impact the management information circular for your 2025 annual shareholder meeting and your 2025 annual disclosure filings.
Subscribe and stay up to date with the latest legal news, information and events . . .
© Norton Rose Fulbright LLP 2025