Compliance & certifications
Built for regulated markets.
Backed by the right documentation.
Stop chasing documents. Approved partners get the files behind their products and orders organised inside the Customer Portal, from declarations and test reports to batch and shipping documentation. Less chasing. Faster execution. More business.
At a glance
Independent expertise
Serious compliance needs more than our own word.
Every year, we invest in EU representation, notified-body assessment, quality-system certification and independent laboratory testing. Different specialists do different jobs. The relevant evidence stays connected to the product inside your Customer Portal.
MDSS GmbH
EU representation for applicable F. Bosch medical devices.
Continental Medical B.V.
EU representation for applicable F. Bosch surgical gloves.
SATRA Technology Europe Limited
EU type-examination and PPE conformity assessment for applicable F. Bosch products.
Centrocot
Conformity assessment for applicable protective clothing, including Category III products within the relevant certification scope.
Bureau Veritas Hong Kong Limited
Independent certification of the applicable F. Bosch quality-management system under EN ISO 13485:2016.
BSI Group The Netherlands B.V.
MDR conformity assessment for applicable medical devices where notified-body involvement is required.
Independent laboratory testing
Product-level testing against the standards and performance requirements relevant to each product.
Different specialists. Different responsibilities. One document trail.
Accessible through your Customer Portal.
Issuing and testing organisations vary by product and regulatory route.
Medical devices
Medical Device Regulation
The European regulatory framework governing applicable F. Bosch medical devices.
The product, legal manufacturer, Declaration of Conformity, CE information and regulatory route all need to match. Exactly.
The applicable EU Declaration of Conformity, legal-manufacturer details, CE information, EU Authorised Representative details and notified-body documentation where required.
Medical Gloves for Single Use
Four parts covering freedom from holes, physical properties, biological evaluation and shelf life.
A specification says what a glove should do. A test report shows what was actually tested.
EN 455-1 requires an AQL of 1.5 for examination gloves and 0.65 for surgical gloves for freedom from holes.
Applicable EN 455 test reports linked to the exact glove model, with test dates, results, sizes and batch or sample information where available.
Traceability built into the product record
Applicable medical devices are assigned the regulatory identifiers required under MDR.
The Basic UDI-DI links the device family to its regulatory documentation and EUDAMED record. The UDI carried at the applicable device or packaging level supports identification through the supply chain.
The applicable Basic UDI-DI, UDI-DI and related product identifiers shown against the F. Bosch product code inside the Customer Portal.
Ready for your market
Labelling and instructions for use, where required, must meet the requirements of the destination market.
The product can be compliant and still be delayed by the wrong language or labelling.
English, German, French and Greek are currently supported, with additional market-specific languages prepared where required. Applicable regulatory symbols follow EN ISO 15223-1:2021.
Protective & industrial
Personal Protective Equipment Regulation
The European regulatory framework for applicable personal protective equipment.
The CE mark is only the visible part. Customs, customers and regulators may ask for the conformity file behind it.
The applicable EU Declaration of Conformity, PPE category, CE information, notified-body details and supporting conformity documentation for the exact product.
Module B + C / C2 / D
The conformity route depends on the PPE risk category.
| Category II | Module B + Module C |
|---|---|
| Category III | Module B + Module C2 or Module D |
This is where customs clearance can become painful. Having the CE mark is not enough when somebody asks for the documents behind it.
For applicable PPE, the relevant EU Type-Examination certificate and the required conformity-to-type or production-assurance documentation, together with the notified-body details.
Protection Against Chemicals and Micro-organisms
The standard series behind chemical and microorganism protection claims for applicable protective gloves.
Type A, B or C on the box is useful. The underlying performance report is better.
Applicable performance classifications and test evidence, including chemical permeation, degradation, air and water leak and microorganism or virus testing where relevant.
General protective-glove requirements are covered by EN ISO 21420. Chemical permeation testing is performed using the applicable test method, including EN 16523-1.
Evidence behind the material
Applicable products are supported by chemical and material-safety testing relevant to their composition and intended use.
Chemical requirements change. A five-year-old PDF is not a compliance strategy.
Applicable REACH/SVHC screening and material-safety reports, including relevant testing for restricted or monitored substances.
Regulation (EC) 1935/2004
Applicable products intended for food contact are supported by the relevant declarations and testing.
“Food safe” is a claim. The declaration and migration results are the evidence.
The applicable food-contact declaration and supporting test documentation, showing the relevant material and conditions of use. For applicable plastic materials, documentation includes Regulation (EU) 10/2011.
European conformity
The mark is visible. The evidence sits behind it.
CE marking follows completion of the applicable conformity-assessment process.
When a customer, customs officer or regulator asks a question, the logo on the box is not the answer. The supporting file is.
The applicable EU Declaration of Conformity, CE information and supporting conformity-assessment documentation matched to the exact product.
Company & quality
Quality Management Systems for Medical Devices
The internationally recognised quality-management standard developed specifically for organisations involved in medical devices.
Quality is a system, not a final inspection.
ISO 13485 provides the framework behind controlled processes, traceability, supplier management, corrective actions and regulatory documentation within the certified scope.
The applicable current ISO 13485 certificate showing the certified organisation, scope, certificate number and validity period. No generic certificate. You can see exactly what it covers.
We do our part before you import. Yours stays clear.
If you act as the EU importer of an F. Bosch medical device, MDR Article 13 gives you specific legal responsibilities. We cannot take those responsibilities away. We can make the evidence you need to fulfil them much easier to manage.
| F. Bosch provides | As EU importer, you verify or maintain |
|---|---|
| Applicable Declaration of Conformity and regulatory documentation | Verify the CE marking, declaration, manufacturer, Authorised Representative and required certificates before placing the device on the market |
| EU Authorised Representative details | Verify the required manufacturer and representative information |
| Applicable UDI and EUDAMED product information | Maintain your own importer registration and required EUDAMED information |
| Product labelling and supported-language documentation | Confirm the requirements of your destination market |
| Batch and product traceability information | Maintain the records required for products you receive and distribute |
| Storage and transport requirements | Maintain the required conditions while products are under your responsibility |
| Complaint and regulatory communication route | Forward complaints, suspected incidents and non-conformities as required |
| Product regulatory file | Ensure your importer identification is provided as required under MDR |
Your obligations stay yours. The paperwork should not slow you down.
Customer Portal
The right document. The exact product. The current version.
Approved partners see documentation as structured records, not a folder full of mystery PDFs.
- Certificate
- 2777/23375-01/E03-01
- Products
- FBGLVE-3021 to 3025 · FBGLVE-3051 to 3055
- Valid to
- 11 January 2028
- Certificate
- IT325957-1
- Standard
- EN ISO 13485:2016
- Scope
- Design, development and supply of the disposable range
- Validity
- Pulled directly from the certificate register
- Report
- Shown against the applicable product
- Product
- FBGLVE-1031
- Status
- Named in the applicable regulatory documentation
The SATRA certificate/product mapping and the ISO certificate number/scope come from the internal Regulatory review.
One product. One document trail. A few clicks.
Every record should show, where applicable: Document type · Issuing organisation · Certificate/report number · Product codes · Issue date · Validity date · View PDF
Everything behind the order. In a few clicks.
Declarations. Certificates. Test reports. Batch documentation. IFUs. Sterilisation certificates where applicable. Shipping files. Organised by product and order inside your Customer Portal.
No email chains. No document chasing. Just the file you need, when you need it.
Products, standards, issuing organisations and documentation requirements vary by item and destination market. The product-specific documentation in the Customer Portal governs.
Report a suspected incident or product complaint to info@fbosch.com.hk. Our team will review it and respond in writing.