How to place a medical device in Switzerland (Regulations)

G

Gargi

#1
#1
Hello Elsmar,:bigwave:

As Switzerland dont come under European Economic Area (EEA) , how medical devices are regulated in this market?
:confused:
I would appreciate a detailed info if possible:applause:

Best Regards,
Gargi
:thanks::thanks:
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
D

davidbrown

#2
#2
Re: How to place a medical device in Switzerland???

In Switzerland, enforcement on medical devices is conducted by the Swiss Agency for Therapeutic Products, Swissmedic.
 
P

Pads38

Moderator
#3
#3
Switzerland has concluded treaties with EU Member States, EFTA States and Turkey with regard to the mutual recognition of conformity assessments for medical devices (bilateral agreements or mutual recognition agreements - MRAs). The basis for these treaties consists of the application of the European guidelines on medical devices and the European CE mark. The States concerned recognise the certificates issued by the Swiss conformity assessment bodies, and in return, Switzerland recognises conformity assessments carried out by Notified Bodies / Conformity Assessment Bodies in the States in question.

The treaties simplify the mandatory reporting requirements for placing devices on the market, and permit direct distribution from Switzerland to all EU and EFTA Member States and Turkey, without an authorised representative with registered offices in the said countries. In return, companies with registered offices in the countries concerned can distribute compliant medical devices directly to Switzerland.
Click to expand...
From here:
https://www.swissmedic.ch/medizinprodukte/02636/03167/index.html?lang=en

Do check that link as there are further requirements.
 
G

Gargi

#4
#4
Re: How to place a medical device in Switzerland???

davidbrown said:
In Switzerland, enforcement on medical devices is conducted by the Swiss Agency for Therapeutic Products, Swissmedic.
Click to expand...
Thank you David.
I would appreciate if I would get the precise comparison b/w CE and Swissmedic.
What I mean is How exactly it differs forom CE roadmap procedure.
Any help would be genuinely appreciated.

Thank you.
Gargi


Always pass on what you have learned
 
G

Gargi

#5
#5
Hi Pads38,

Thank you for that prompt info.
I appreciate you for time taken to anwer my query.

Thanks
Gargi

Always pass on what you have learnt
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Essential info on the name place of a CE marked medical product EU Medical Device Regulations 1
C How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)? Other US Medical Device Regulations 4
shimonv Where do you place Human Factors report in a 510(k) application? Other US Medical Device Regulations 3
I Foreign manufacturer registered place of business in EU for CE certification EU Medical Device Regulations 1
M Testing criteria - where to place Design and Development of Products and Processes 2
L Where to place the what/when/how/who/where procedures in a multi-regulation AS9110C organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Brexit When does the UK responsible person need to be in place? UK Medical Device Regulations 10
C Where to place CE/label in Sterile IVD EU Medical Device Regulations 1
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
V What plans have been put in place to achieve quality objectives? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
R Supplier Controls we can place on Single-Source Suppliers ISO 13485:2016 - Medical Device Quality Management Systems 2
K About ionizers - How far can we place a table top ionizer from the IC devices Manufacturing and Related Processes 1
P Why does the standard clause use the term Issues in place of Context - ISO 27001 4.1 IEC 27001 - Information Security Management Systems (ISMS) 3
C IATF 16949 : 2016 - How put in place a Containment for this kind of Major NC IATF 16949 - Automotive Quality Systems Standard 14
B Best place is to purchase IEC 60417 labels that will pass markings test IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S Importer and Registered Place of Business in EU EU Medical Device Regulations 1
Q Where to place a Down Stream Gage Inspection on an FMEA FMEA and Control Plans 5
somashekar How to put in place a Risk Assessment of Vulnerabilities & Corruption... Sustainability, Green Initiatives and Ecology 2
S Where is a good place to get IMDS (International Material Data System) Training? IATF 16949 - Automotive Quality Systems Standard 3
R OHSAS 18001:2007 Section 3 - Controlling Work Place Risks Occupational Health & Safety Management Standards 3
S Use of SS304 in place of SS301 (Stainless Steel) Nonconformance and Corrective Action 4
U When does design transfer take place? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 30
S Do you have all your SOPs in place vis a vis 2013/473/EU CE Marking (Conformité Européene) / CB Scheme 3
T Best place in QMS to manage Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
U Major Nonconformance - We had a control in place that was not on the control plan IATF 16949 - Automotive Quality Systems Standard 14
S How does each element of OHSAS contribute to management of work place safety & health Occupational Health & Safety Management Standards 7
N Elsmar Cove Forum - What an amazing place Coffee Break and Water Cooler Discussions 8
C How long does AS9100 QMS need to be in place before the Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
G Verifying the Documents we have in place AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
C Will Ford accept AS9100 certification in place of ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
I What information do you place in a "register"? Quality Manager and Management Related Issues 2
R Using Curve Fits and Predictions in place of good old Measurements General Measurement Device and Calibration Topics 3
I What do you have to put in place for Sterile Procedure Packs? MDD Article 12 ISO 13485:2016 - Medical Device Quality Management Systems 1
M MSA - According to the formula cg how much tolerance should be put in place? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
W Excel Number Formatting - Auto Decimal Place by What You Type Excel .xls Spreadsheet Templates and Tools 16
5 Promoting 5S in the Work Place - What's the best way to do it? Quality Tools, Improvement and Analysis 9
W What are "typical software risks"? Is IEC/TR 80002-1 a good place to look for a list IEC 62304 - Medical Device Software Life Cycle Processes 6
O Classification of Instrumentation Used to Place Implant 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
H Best place to keep myself updated on EU Regulatory Changes EU Medical Device Regulations 7
B Having trouble writing a directive (procedure) that points to the right place ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
A How relevant are ASQC CQT, CQE, CMI Completion Diplomas in the Current Work Place Career and Occupation Discussions 9
M Oxygen Data Logger that we can place with each shipment via aircraft ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Best Place to Purchase a Copy of ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Final CIP (Clean in Place) WFI (Water For Injection) Rinse Temperature Misc. Quality Assurance and Business Systems Related Topics 7
I How to deal with Behaviour Problem in the work place? Human Factors and Ergonomics in Engineering 20
N Putting SOPs in place in preparation for ISO certification - where to start? Service Industry Specific Topics 5
D Need to get design checklist in place very quickly - as advised by auditor ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
1 Putting Quality in place before shipping product Quality Manager and Management Related Issues 18
K Popular Sports in your Place Coffee Break and Water Cooler Discussions 22

Similar threads

Top Bottom