1. Scrip
  2. >>Archive

Medical Device Regulations

Changes to Swiss ordinances affecting devices

Amendments to two Swiss ordinances affecting the clinical testing, regulatory approval and marketing of medical devices in Switzerland came into effect on 1 September 20041. The ordinances - the MedicalDevicesOrdinance, MepV, SR 812.213, and the Clinical Trials of Therapeutic Products Ordinance, Vklin, SR 812.214.2 - are two of the regulations adopted in support of the Swiss Therapeutic Products Law (Heilmittelgesetz). They cover implants, instruments, medicinal equipment, in vitro diagnostics and materials for use with the above mentioned categories.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Archive

Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

More from Scrip

Pfizer’s Danuglipron Is Done, Sparking M&A Speculation

 
• By Jessica Merrill

The company discontinued development of its oral GLP-1 receptor agonist for weight management due to a safety signal.

Amgen’s Imdelltra Sets The Pace In Small-Cell Lung Cancer

 
• By Andrew McConaghie

The bispecific is the first in its class to record a Phase III survival win in small-cell lung cancer, although antibody-drug conjugates and other rivals could challenge in the coming years.

Pipeline Watch: Ten Approvals And Eleven Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.