With the transition period of Swiss medical devices regulations officially ending on July 31,2022, all medical devices are currently required to be individually designated as a Swiss representative (CH-REP) when exported to Switzerland. As a professional medical device consulting company, SUNGO constantly strives to provide Chinese enterprises with custom-made device compliance services in line with international standards.
By March 2023, SUNGO has provided Swiss authorized representative services for nearly 30 enterprises and successfully completed the record filing of Swiss authorized representative. At the same time, SUNGO has prepared technical documents that comply with the requirements of Swiss regulations for these enterprises.
The Swiss medical device regulatory authority Swissmedic has also released a list of frequently asked questions (FAQ) about device announcements for Swiss medical device manufacturers, and answered these FAQ about medical device notification. It specifies which devices need to be notified by the authorities before marketing.
Let's take a look at the guidelines:
01
Which devices must be notified to Swissmedic? Who must submit an application?
a. Custom-made device. Such device notification must be submitted by the manufacturer, importer or authorized representative in Switzerland before the product is put on the market;
b. Repackage or relabel the device. Under such situation, the device must be notified by importers and distributors in Switzerland;
c. For Class I medical devices (including general Class I and Class I sterilization, Class I measurement, Class I reusable devices, active implantable medical devices, systems and procedure pack) in accordance with the MDD. Such devices should only be notified by the manufacturer in Switzerland. Swiss authorized representatives are not required to submit notification application.
02
Do manufacturers of Class I medical devices in other countries outside Switzerland/EU/EEA need to submit an application of notification?
Not required. However, the device must meet the requirements of the MedDO. A non-Swiss device manufacturer can market its products in Europe only if it has an authorized representative in Switzerland.
03
Is the product code (EMDN/GMDN) required in the notification application?
Yes
04
How long is the processing time for the application?
About 1 month after receiving the application.
05
When an application of notification change is required?
A notification change application is required only if the name or address of the economic operator, the intended use of the product or its components, classification, or product name changes
I would like to highlight that recently SUNGO has also successfully provided Swiss medical device compliance services for an oral custom-made device, signed the Swiss authorized representative agreement, carried out the record filing of authorized representative, submitted the notification application of custom-made device, and successfully obtained the approval of the authorities. During the project, SUNGO's professional service has been unanimously recognized by the manufacturer and the competent authorities.
The services offered by SUNGO
1）
As the manufacturer's designated Swiss representative, fulfill the obligations of the Swiss representative according to MedDO/IvDO;
2）
Application of notification for customers' medical devices (when necessary);
3）
Prepare/review manufacturer's technical documents to meet MedDO/IvDO requirements;
4）
Swiss regulation training and PRRC training;
5）
Assist manufacturers to implement the relevant requirements of post market surveillance system;
6）
Timely follow the updates and changes about relevant requirements of the Swiss authorities and pass them to the manufacturers, and assist in the arrangement of follow-up compliance strategies.
