Incentive

According to articles 53 and 54 of the Swiss Medical Devices Ordinance (812.213), distributors and importers carrying out certain activities, such as translating instructions for use or repackaging products, must provide a certificate from a Designated Body. SQS offers certifications to obtain these certificates, which are recognised in Switzerland.

Outcome

After successful certification, you will receive the corresponding certificate and you will demonstrably have an effective quality system in relation to the activities described.

Target groups

Swiss distributors and importers of medical devices carrying out activities in accordance with MDR Article 16(2)(a) and (b).

Validity

3 years - after 12 to 24 months a surveillance audit takes place.

Recognition

SQS is designated by Swissmedic with the identification number 1250. The SQS certificates are recognised in Switzerland.

Combinations

Certification according to Article 16(4) is compliant with ISO 13485.