Certificates & Approvals
Liton Laser holds numerous certifications; whether pertaining to corporate management systems or product quality, each is backed by rigorous documentation.
Our extensive range of certificates is applicable to every country worldwide, and for specific certifications, equivalent versions are available from various different laboratories.
Production System Certification
Liton Laser holds an ISO medical device quality management system certificate, complying with the certification standard directive: ISO 13485:2016.
Our production, research and development, assembly, testing, and packaging all meet relevant regulations.
ISO 13485 Certification
ISO 13485 is a quality management system standard applicable to the regulatory environment of medical devices. Its full name is "Medical devices—Quality management systems—Requirements for regulatory purposes."
Compared to ISO 9001, which is applicable to all types of organizations, ISO 13485 is more specialized, focusing on the design, development, production, storage and distribution, installation, and service of medical devices.
ISO 13485 Approval
ISO 13485 is a quality management system standard specific to the medical device industry. The current version is ISO 13485:2016, which covers ISO 9001 and some other requirements.
To obtain the CE marking, indicating compliance with safety standards for products sold in the European Economic Area, medical device manufacturers must obtain certification from a designated body or establish a quality system.
Our Standards And Specifications
Laws and Regulations
It emphasizes compliance with medical device regulations (such as EU MDR/IVDR, US FDA 21 CFR 820, and China's Good Manufacturing Practice for Medical Devices), not just quality management.
Organizations are required to integrate regulatory requirements into their systems, including product registration, clinical evaluation, and post-market surveillance.
Risk Management
Throughout the entire product lifecycle (design and development, production, storage, distribution, etc.), compliance with ISO 14971 "Medical Device Risk Management" is required.
Document control and traceability: Strict document and record control ensures product traceability (UDI unique identifier, batch records, etc.).
Special Process Validation
Special processes such as sterilization and aseptic packaging require validation and continuous monitoring.
Customer feedback and adverse event handling procedures should be established to handle complaints, adverse events, and recalls, fulfilling regulatory reporting obligations (such as the EU's Vigilance system and the US FDA's MAUDE).
Equipment Certificate Approval
US Certificate FDA Approval
As one of the world’s most authoritative product safety regulatory agencies, FDA (U.S. Food and Drug Administration) compliance certification is a “passport” for products to enter the U.S. market.
The FDA is an agency under the U.S. Department of Health and Human Services, whose core responsibility is to ensure the safety, efficacy, and accurate labeling of food, drugs, medical devices, and other products.
Liton Laser adheres to the requirements of the Americas market, providing clinic-grade medical devices. With professionally certified machines, these devices are safer and more reassuring for customers and patients.
If you need to test Liton Laser’s FDA 510(K) number, please feel free to contact us.
- FDA Registration
- FDA Testing
- FDA Approval
Electrical CE Certificate
Electrical CE certification for the machine is also essential, serving as proof of its basic safety and compliance with regulations. Liton Laser holds electrical CE certificates from laboratories in multiple countries, including China, Turkey, Poland, and Italy. Our electrical CE certificates comply with Directive 2014/35/EU and Directive 2014/30/EU.
Medical CE Certificate
MDR 2017/745 (EU)
MDD 93/42/EEC
MDD/MDR Directive
The Medical Devices Directive (93/42/EEC) has a broad scope, covering almost all medical devices except for active implantable and in vitro diagnostic devices, such as passive medical devices (dressings, disposable products, contact lenses, blood bags, catheters, etc.); and active medical devices, such as MRI scanners, ultrasound diagnostic and therapeutic instruments, infusion pumps, etc.
CE-MDR is a CE certification obtained under the framework of the latest EU Medical Device Regulation (MDR) Directive 2017/745 (EU), which replaces the previously familiar CE-MDD (Medical Device Directive) system.
- MDD focuses on "whether the product can be launched on the market."
- MDR focuses more on "whether the product can be used safely and effectively in the long term."
Environmental Protection & Sales
RoHS Certification
RoHS certification, also known as environmental certification, complies with European and American standards. It is an abbreviation for the “Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Directive”.
The European RoHS 2011/65/EU requires testing for six substances, and the directive is now known as the RoHS Directive.
Free Sale Certificate
A Free Sales Certificate, also known as a Certificate of Free Sale, is used to prove that the sale of a specific product in the destination country is legal and complies with local laws and quality and safety standards.
This certificate is commonly used in international trade as a way to establish trust between buyers and sellers, and it is also an important document required by importers when importing products.
Free Sale Certificate
RoHS Certificate
Certificate Test Report
Biocompatibility Report
In recent years, biocompatibility testing has been given great importance, primarily aimed at determining whether it will cause harm to people’s bodies and skin. Generally speaking, medical devices and pharmaceuticals must undergo biocompatibility testing, which is an important step before products enter clinical trials and requires detailed analysis of subsequent sales performance.
- Ensure safety
- Strict regulations
- Enhance trust
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Skin Sensitization
To assess potential allergic reactions, tests are typically performed via skin contact or intradermal injection. The testing is based on GB/T 16886.10-2017.
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Skin Irritation
To assess the irritant effect of medical devices or materials on local tissues, skin or mucous membrane contact tests are conducted to observe for symptoms of irritation such as redness, swelling, and pain. Testing standard: GB/T 16886.10-2017.
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In Vitro Cytotoxicity
To assess the impact of medical devices or materials on cell growth and viability, in vitro cell culture methods are typically used to observe the effect of material extracts on cells. The testing standard is GB/T 16886.5-2017.
Security Test Report
Each certificate applied for by Liton Laser comes with a corresponding test report. Common reports include LVD test reports, EMC test reports, and laser safety test reports. These reports provide substantial evidence that the product complies with relevant EU directives (such as the Low Voltage Directive (LVD) and the Electromagnetic Compatibility Directive (EMC), and detail the testing process, methods, and results, issued by a qualified laboratory.
LVD Test Report
The Low Voltage Directive (LVD 2014/35/EU) aims to ensure the safety of low-voltage equipment during use. It applies to electrical products operating on voltages between 50V and 1000V AC and 75V and 1500V DC.
This directive contains all safety rules for such equipment, including protection against hazards caused by mechanical failure. The equipment must be designed and constructed to ensure that no danger arises when used for its intended purpose, under normal operating conditions or fault conditions.
EMC Test Report
EMC testing, also known as electromagnetic compatibility (EMC), refers to the comprehensive evaluation of the electromagnetic interference and immunity capabilities of electronic products.
It is one of the important indicators of product quality. EMC measurement consists of a test site and test instruments.
The purpose of EMC testing is to detect the impact of electromagnetic radiation generated by electrical products on the human body, public power grids, and other normally functioning electrical products.
Laser Safety Report
Laser safety reports, based on international or national standards (such as IEC 60825-1, GB 7247.1, etc.), comprehensively assess the safety performance of laser products to ensure that they will not cause harm to personnel, equipment, or the environment under normal use and reasonably foreseeable misuse, while also meeting market access and regulatory compliance requirements.
For machines intended to be classified as medical devices (compliant with MDR/FDA standards), laser safety reports are mandatory.
Declaration Document & Tags
A declaration of conformity is a document that needs to be signed by the manufacturer, stating that a product sold within the European Union complies with the basic requirements of the relevant European product safety regulations.
The CE label (European Conformity) is a mark of product compliance in the European Union market, indicating that the product meets the EU’s basic requirements for safety, health, environmental protection, and consumer protection.
Declaration of Conformity
The EU Declaration of Conformity (DoC) is a mandatory document that manufacturers or our authorized representatives must sign to declare that our products comply with EU requirements. Signing the DoC signifies that we assume full responsibility for the machines sold in accordance with applicable EU law.
Required information:
- Name and address of the manufacturer or authorized representative.
- Product model, batch number, or serial number, and other identifying information.
- List of applicable EU directives/regulations.
- Referenced harmonized standards or technical specifications.
- Name, title, and signature of the signatory.
- Place and date of publication of the declaration.
It is important to note that the DoC must be in the official language of the member country where the product is sold, or a language acceptable to that member country.
More Certificate Details
