France Medical Device Registration QA
Email: par4ww@evershinecpa.com
Manager Zhu, speak in French English and Chinese
HLF-FR-10
What are the categories of medical devices in France? What is its official name? What is the intensity of management of different categories? What is the governmental authority of medical devices? Website?
Evershine RD
The EU divides medical devices into two categories:
1. Medical device: refers to any instrument, device, appliance, software, implant, reagent, material or other item, alone or in combination, for use in humans for one or more specific medical purposes.
．Diagnosis, prevention, monitoring, prediction, prognosis, treatment or mitigation of disease.
．Diagnosis, monitoring, treatment, mitigation or compensation of injury or disability.
．Investigation, replacement or modification of anatomical structures, physiological or pathological processes.
．It is applied to the in vitro examination of the human body, including organs, blood and tissues, and cannot achieve its main intended effect in the human body or in the human body by pharmacological, immunological or metabolic means, but its function can be assisted by these medical devices.
The following products shall also be considered medical devices:
．A device that controls or supports conception.
．Products specifically designed to clean, disinfect or sterilize medical devices.
2. In-vitro diagnostic medical device: refers to any medical device in the form of reagents, reagent products, calibrators, control materials, kits, instruments, equipment, equipment, software or systems in the form of reagents, reagent products, calibrators, control materials, kits, instruments, equipment, software or systems, used for in vitro examination of specimens from the human body , including blood and tissue.
．associated with a physiological or pathological process or state
．Associated with a congenital physical or mental disorder
．Associated with physical condition or predisposition to disease
．Identification of safety and compatibility with potential recipients
．predict treatment response
．Define or monitor treatment measures
Specimen containers should also be considered in vitro diagnostic medical devices.
The risk level is from low to high: Class I products need to be affixed with the CE mark, and self-declaration can be adopted. Class II(a), Class II(b), Class III products to be affixed with the CE mark must be verified by an EU-designated certification body.
1. Class I: Non-sterile or non-measurable (low risk)
2. Class I: Sterile and capable of measuring (low/medium risk).
3. Class IIa (moderate risk)
4. Class IIb (medium/high risk)
5. Class III (High Risk)
In France, the National Agency for the Safety of Medicines and Health Products (ANSM) under the Ministry of Health oversees and regulates medical device.
【參考連結】
https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
HLF-FR-20
If a foreign company wants to sell medical devices in France, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
無須申請營業特許證。
No business license is required.
【參考連結】
HLF-FR-25
假如需要辦理，請問法國有專業服務公司可以協助辦理醫療器材公司營業許可證？
Evershine RD：
無須申請營業特許證。
HLF-FR-30
If a foreign company wants to sell medical devices in France, can it assign a France company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
No business license.
Manufacturers and health professionals must immediately report to ANSM all accidents or risks of accidents that they are aware of in the event of serious adverse reactions following the use of medical devices.
Manufacturers have a post-marketing vigilance and surveillance reporting obligation.
When a medical device is found to be non-compliant, the distributor must immediately notify the manufacturer, the authorized representative and the importer, and is obliged to report the discovery of serious risks to the competent authority (ANSM); the importer must notify the manufacturer and the authorized representative immediately, and Obligation to report to the Competent Authority (ANSM) where serious risks are identified
When medical products must be withdrawn/recalled, the cooperation of distributors, manufacturers, authorised representatives, importers and competent authorities to ensure that necessary corrective actions are taken.
URL:https://signalement.social-sante.gouv.fr/psig_ihm_utilisateurs/index.html#/accueil
【參考連結】
HLF-FR-35
假如需要辦理指派法國公司擔任營業代理人，請問法國有專業服務公司可以協助？
Evershine RD：
Bernas Medical
http://www.bernas-medical.com/en
Gamida
https://www.gamida.fr/uk/home.html
SHMC
HLF-FR-40
Do foreign companies need to apply for an approval before importing medical devices sold to France? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
Medical devices must be registered on the EU website (EUDAMED) as a company in France or an EU member state, and the product must be registered in one of the EU member states. If the product has not been registered in an EU member state, it must be registered with the French competent authority (ANSM).
EU (EUDAMED) registration process
1. Role registration (manufacturer/authorized representative/importer)
．Company Name/Applicant Name
．Contact number, Email
．Country, city, street, zip code, etc.
2. UDI/Device Registration
．Manufacturer’s name, address
．Risk class
．Measurement function (yes/no)
．Reusable surgical instruments (yes/no)
．Active device (yes/no)
．Identify the device model
．Technical file or certificate of conformity/declaration
．Equipment Quantity
．Use unit
．Clinical scale
．Additional Product Description
．Single use (yes/no)
．Maximum number of reuses
．Does it need to be sterilized?
．CMR/endocrine disruptor
．Serious Warnings or Contraindications
．Medical Device Nomenclature (CND) codes, etc.
3. Certificates and Notified Bodies
．Product Category Certificate: EU Type Inspection Certificate, EU Technical Document Certificate, EU Product Verification Certificate.
．Quality grade certificates: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.
4. Clinical investigations and performance studies (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)
7. Licenses issued by the European Union are valid for 5 years.
French (ANSM) medical device registration
1. All Class I medical devices must be registered with ANSM, Class IIa, IIb and III devices must be notified before they can be marketed, and all medical devices must bear the CE mark to be sold in France.
2. There is no electronic procedure in France, registration and notification are done by submitting a paper application form and submitting documents to ANSM.
3. Process
．Equipment classification
．Submitted documents: ISO13485 certification, document analysis, CE technical document compilation, etc.
．Appointed European Authorised Representative (EAR)
．Submit to the European Union
．Review qualified
．Notify the competent authority (ANSM)
Labeling and Instructions for Use:
1. Each product must be accompanied by all safety and performance information required for safe use, identification of the product, manufacturer or authorized representative.
．The manufacturer’s address must be the address of the registered office of the person responsible for placing it on the market and must include the following information: street/road, quantity/building/floor, zip code, town, state/region (if applicable), nation
2. In France, labels of medical devices, accompanying leaflets and any other information regarding their operation or use must be in French.
3. The label shall state that this product is a medical device.
4. The information provided by the manufacturer shall use symbols recognized in international format.
5. It is recommended to check the translation, the manufacturer will be held responsible for personal injury to the patient or others due to incorrect or misleading translation.
【參考連結】
https://ec.europa.eu/tools/eudamed/#/screen/home
HLF-FR-45
請問在法國有哪些專業服務機構，可以協助辦理醫療器材產品許可證？
Evershine RD：
THEMA
EMERGO
Freyr
https://medicaldevices.freyrsolutions.com/
Regdesk
OMC
EMERGO
HLF-FR-50
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed?Website?
Evershine RD：
Medical devices must be registered on the EU website (EUDAMED) as a company in France or an EU member state, and the product must be registered in one of the EU member states.
If the product has not been registered in an EU member state, it must be registered with the French competent authority (ANSM).
EU (EUDAMED) registration process
1. Role registration (manufacturer/authorized representative/importer)
．Company Name/Applicant Name
．Contact number, Email
．Country, city, street, zip code, etc.
2. UDI/Device Registration
．Manufacturer’s name, address
．Risk class
．Measurement function (yes/no)
．Reusable surgical instruments (yes/no)
．Active device (yes/no)
．Identify the device model
．Technical file or certificate of conformity/declaration
．Equipment Quantity
．Use unit
．Clinical scale
．Additional Product Description
．Single use (yes/no)
．Maximum number of reuses
．Does it need to be sterilized?
．CMR/endocrine disruptor
．Serious Warnings or Contraindications
．Medical Device Nomenclature (CND) codes, etc.
3. Certificates and Notified Bodies
．Product Category Certificate: EU Type Inspection Certificate, EU Technical Document Certificate, EU Product Verification Certificate.
．Quality grade certificates: EU quality management system certificate, EU quality assurance certificate, EU production quality assurance certificate.
4. Clinical investigations and performance studies (in development)
5. Vigilance and post-market surveillance (in development)
6. Market surveillance (under development)
7. Licenses issued by the European Union are valid for 5 years.
French (ANSM) medical device registration
1. All Class I medical devices must be registered with ANSM, Class IIa, IIb and III devices must be notified before they can be marketed, and all medical devices must bear the CE mark to be sold in France.
2. There is no electronic procedure in France, registration and notification are done by submitting a paper application form and submitting documents to ANSM.
3. Process
．Equipment classification
．Submitted documents: ISO13485 certification, document analysis, CE technical document compilation, etc.
．Appointed European Authorised Representative (EAR)
．Submit to the European Union
．Review qualified
．Notify the competent authority (ANSM)
Labeling and Instructions for Use:
1. Each product must be accompanied by all safety and performance information required for safe use, identification of the product, manufacturer or authorized representative.
．The manufacturer’s address must be the address of the registered office of the person responsible for placing it on the market and must include the following information: street/road, quantity/building/floor, zip code, town, state/region (if applicable), nation
2. In France, labels of medical devices, accompanying leaflets and any other information regarding their operation or use must be in French.
3. The label shall state that this product is a medical device.
4. The information provided by the manufacturer shall use symbols recognized in international format.
5. It is recommended to check the translation, the manufacturer will be held responsible for personal injury to the patient or others due to incorrect or misleading translation.
【參考連結】
https://ec.europa.eu/tools/eudamed/#/screen/home
HLF-FR-55
請問在法國有哪些專業服務機構，可以協助以外國公司名義辦理醫療器材產品許可證？
Evershine RD：
EMERGO
THEMA
HLF-FR-60
What documents are required when importing approved medical devices into France? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
．證明符合 EC 或法國標準的文件
Products bearing the CE certification label can be sold freely in all European Economic Community (EEC) member states without the need to undergo product testing in other countries.
Goods manufactured outside the EU must have a full customs declaration in order to be freely sold within the EU market. Businesses and individuals wishing to trade are required to use the Economic Operator Registration and Identification Number (EORI) as their identification number in all customs procedures.
The EORI number is an operator identification number valid throughout the EU, and the CE compliance mark must be affixed to the product when medical device is imported or sold.
Customs
1. Registration and identification of economic operators
Registered with French customs to obtain EORI number
Contents of application form:
． Company Name/Name (Natural Person)
． Creation Date/Birthday
． Address, phone, email
． Contact person
． SIRET number
． VAT number
2. Complete the electronic customs declaration on the Delta website, including the declaration form (air or sea manifest), single administrative document (SAD).
Contents of declaration form
． Operator’s name and EORI
． Customs Clearance Office Code
． Customs code
． Number of packages
． Sender’s name and address, recipient’s name and address
． Commercial description of the item
． Total mass in kilograms
． Country of origin code
． Invoice value and currency
． Import declaration, etc.
Single Administrative Document (SAD)
． Shipper
． Recipient
． Declarer
． Means of transport, country on departure
． Transit conveyance, country
． Shipping method
． Commercial number
． Payment method
． Destination code
． Terms of Delivery
． Transaction nature
． Container Numbers, Seals and Numbers
． Product code, weight
． Tax calculations
． Arrival date
． Office
． Declarant, etc.
3. Required documents for customs clearance
．Invoice, which should be written in French (or accompanied by a translation)
．Measurement (units must be in metric)
．Shipping Documentation (LTA/AWB, Maritim Connaissement/Bill of Lading, LTM, CMR or LVI)
．Declaration of Origin under CETA Agreement
．Documents proving conformity to EC or French standards
【參考連結】
https://www.douane.gouv.fr/professionnels
https://www.douane.gouv.fr/demarche/enregistrer-votre-entreprise-aupres-de-la-douane-numero-eori
https://archiveansm.integra.fr/
HLF-FR-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
The sale of medical devices in the European Union (EU) requires CE marking of products: the CE marking should be conspicuously, clearly and indelibly affixed to the device or its sterile packaging. If, due to the nature of the equipment, such affixing is not possible or warranted, the CE marking shall be affixed to the packaging. The CE marking should also appear on any instructions for use and on any sales packaging.
1. The CE marking shall consist of the initials “CE” in the following form:
2. If the CE marking is reduced or enlarged, the proportions given in the scale diagram above shall be observed.
3. The various components of the CE mark shall have substantially the same vertical dimension and shall not be less than 5mm. For small devices, this minimum size can be waived.
Medical devices applying for CE certification according to their classification have the following contents:
1. Class I: self-declaration is enough
2. ClassIIa/ClassIIb/ClassIII: Must comply with the corresponding medical device directives, pass the Notified Body Conformity Assessment Procedure, and obtain the CE certificate.
Precautions:
1. Category I (non-sterile, non-measured) requires compliance with post-market surveillance (PMS) mechanisms.
．Manufacturers should plan, establish, document, implement, maintain and continuously update post-market surveillance systems based on device risk levels and medical material classifications to confirm product safety and efficacy during the product life cycle.
2. All equipment other than Class I (non-sterile, non-measuring) requires the implementation of a quality management system (QMS).
．Products can only be printed with the CE mark after obtaining the certification documents. Manufacturers, agents or importers have been tested by the internal product testing department, or they may invite external verification agencies to test the products to implement quality management to ensure that the mass-produced products meet the samples that have passed the inspection.
3. For Class I to Class IIb, a technical file is required, and Class II/AIMD equipment is a design file.
．The name and address of the manufacturer or any authorized representative
． Brief description of the product
．Identification of the product, such as the product’s serial number
．The name and address of the facility involved in the design and manufacture of the product
．Name and address of any notified body involved in assessing product conformity
． Statement of conformity assessment procedures followed
．EU Declaration of Conformity
．Labels and Instructions for Use
．Statement of relevant regulations to which the product complies
．Identify technical standards claimed to be compliant
．Parts List
．test results
4. Manufacturers of Class IIa, IIb and III devices shall prepare a Periodic Safety Update Report (“PSUR”) for each device and, where relevant to each class or device group, summarizing the results and conclusions.
5. The name and address of the European office or authorized representative are placed on the instructions for use, on the outer packaging or on the device label.
6. For all devices other than Class I (non-sterile, non-measurement), their QMS and technical or design files must be reviewed by a certification body (a third-party audit of medical device companies and products recognized by European authorities).
HLF-FR-75
法國醫療器材審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
醫療器械的CE認證只有在歐盟網站公告的指定驗證機構(歐盟境內)，才具備醫療器械的CE符合性證書發證資格。
HLF-FR-77
請問在法國有哪些醫療器材檢驗機構可以提供醫療器材檢驗服務？網頁？
Evershine RD：
GMED SAS (法國唯一檢驗認證機構)
HLF-FR-80
After a foreign subsidiary imports medical devices and entrusts a distributor in France to sell it, does the distributor need a medical devices business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
No business license is required.
Manufacturers and health professionals must immediately report to ANSM all accidents or risks of accidents that they are aware of in the event of serious adverse reactions following the use of medical devices. Manufacturers have a post-marketing vigilance and surveillance reporting obligation.
When a medical device is found to be non-compliant, the distributor must immediately notify the manufacturer, the authorized representative and the importer, and is obliged to report the discovery of serious risks to the competent authority (ANSM); the importer must notify the manufacturer and the authorized representative immediately, and Obligation to report to the Competent Authority (ANSM) where serious risks are identified
When medical products must be withdrawn/recalled, the cooperation of distributors, manufacturers, authorised representatives, importers and competent authorities to ensure that necessary corrective actions are taken.
【參考連結】
HLF-FR-85
請問在法國有哪些專精於醫療器材銷售與消費權益相關法律服務的業者？
Evershine RD：
Soulier Avocats
https://www.soulier-avocats.com/en/
McDermott
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Manager Zhu, speak in French English and Chinese
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