Chapter 1 Swiss Administration

1. SWISSMEDIC Administration and Abstract

The Swiss Medical Devices Agency (Swissmedic) is the Swiss medical device administration responsible for the registration, evaluation and supervision of medical devices to ensure their safety and effectiveness.

2. Administrative Regulation

Medical Devices Ordinance (MedDO)

Ordinance on In Vitro Diagnostic Medical Devices（IvDO）

3. Risk Level Classification

4. Entry Requirements

ISO 13485 certificate

EC Certificate

5. Registration Language

English, the label must be in one of the official languages of Switzerland (German, French and Italian).

6. Swiss License Holder

In Switzerland, the manufacturer, importer or authorized representative of a medical device may submit an application for registration as an applicant. If the manufacturer of a medical device does not have its place of business in Switzerland, its products may be placed on the market only after the appointment of an authorized representative located in Switzerland (Art. 51 (1) MedDO).

Chapter 2 Registration Flow, Cycle & Official Fee

1. Registration Flow

2. Registration Cycle

Medical devices or IVD products must have passed CE or FDA registration before filing in Switzerland:

The official audit time for Swiss filings is 30 days:

3. Registration Official Fee

The official fee for each registration is CHF 300 and applies to any risk level.

Chapter 3 FAQ

Q: Does it require a QMS certificate for Swiss registration of medical devices?

A: Yes.

Q: Can the registration of medical device products be changed after registration?

A: If the medical device product changes meet the requirements, registration changes can be made according to the procedure.