Export Certification and Standards for Four-Wheeled Mobility Scooters

Export Certification and Standards for Four-Wheeled Mobility Scooters

As the global aging population becomes increasingly pronounced, market demand for four-wheeled mobility scooters continues to rise. For companies planning to export these products to international markets, a thorough understanding and strict adherence to the certification and standards requirements of each country is crucial to successfully entering the international market.

EU Certification and Standards

The EU market is known for its stringent certification requirements and standards. In the case of four-wheeled mobility scooters, EEC certification, also known as e-mark certification, is the primary requirement. This certification system, based on EU Directives, establishes the European Community’s whole vehicle type approval system. Certification member countries include 27, and certification obtained in any one member country is recognized in all other member countries.

Certification Process

Application Submission: The company formally submits a product certification application to the member country’s Ministry of Transport through a professional certification body.
Document Preparation: Under the careful guidance of professional engineers, companies must thoroughly prepare all relevant materials and documents required for certification. This includes company information such as the company’s WMI World Factory Code, business license, ISO9001 or IATF16949 certificate, product trademarks, contact person information, and other company information. Product information also includes test samples, product models, certificates for the six major components (lights, rearview mirrors, horns, tires, glass, and seat belts), technical specifications, and CAD drawings.

Sample Testing: Companies will send carefully prepared test samples to designated laboratories for comprehensive certification testing according to strict standards.

Report Preparation: Based on the standardized product description and the qualified data obtained through testing, professional personnel will prepare a detailed product report.

Internal Review: Engineers will submit the completed report to the Ministry of Transport for a rigorous internal review.
Certificate Issuance: Once the report is reviewed and approved, the Ministry of Transport will officially issue the EEC certification for the product.

Standard Requirements
Vehicle Safety: During the vehicle structural strength test, a hydraulic press is used to simulate a rollover collision scenario, requiring the roof deformation to not exceed 125 mm. This ensures the vehicle can provide reliable safety protection for drivers and passengers in extreme situations. Battery safety testing is extremely rigorous, requiring a series of tests such as needle penetration, crushing, and overcharging to resolutely prevent dangerous situations such as fire and explosion. Electromagnetic compatibility testing is also crucial. The vehicle must still be able to receive remote control signals normally in complex electromagnetic interference environments, effectively preventing abnormalities such as “ghost braking.”

Environmental Requirements: The EU has clear regulations on battery energy density, requiring a minimum of 70Wh/kg and a range of at least 100 kilometers. In addition, automakers must provide a comprehensive battery lifecycle management plan. Germany, for example, mandates that automakers assume battery recycling responsibilities. Failure to do so can result in an environmental tax of up to €200 per vehicle.

US Certification and Standards
The US market has a unique and complex certification and standards system for four-wheeled mobility scooters.

Certification Requirements
FDA Certification: Because four-wheeled mobility scooters are regulated as medical devices in the US, they must obtain 510(k) clearance from the US Food and Drug Administration (FDA). Exporters must submit a detailed application to the FDA, covering product information, manufacturer information, and distributor information, to facilitate a comprehensive review and certification. During the application process, the FDA reserves the right to request additional supporting documentation and may even require additional testing.

Product Classification: According to FDA regulations, four-wheeled mobility scooters are generally classified as Class II or Class III medical devices. Each medical device category must strictly adhere to the corresponding FDA standards. Therefore, before exporting products, companies must clearly identify their FDA classifications so they can conduct certification and testing according to the correct standards.

Standards and Regulations
Quality Standards: Senior mobility scooters must strictly comply with relevant international standards such as ISO 7176. These standards comprehensively cover key aspects of product performance, safety, and reliability, effectively ensuring the stability and safety of the product during actual use.

Product Performance:
Battery Life: The US market places high demands on the battery life of senior mobility scooters. Products must be equipped with batteries of sufficient capacity and efficient energy management systems to fully meet the travel needs of seniors in various road conditions and usage scenarios.
Speed ​​and Gradeability: The speed of senior mobility scooters must strictly comply with relevant US regulations and possess good gradeability to adapt to the diverse terrain conditions of the United States.
Controllability: The product should have an easy-to-understand operating system that allows seniors to quickly learn how to use it. Furthermore, the controllability must be stable and reliable to ensure the personal safety of seniors during use. Safety Requirements: The vehicle’s structure must be strong and durable, capable of withstanding certain impact forces. For example, in the event of a collision, the vehicle’s structure must effectively protect the driver and passengers.

Indian Certification and Standards
The Indian market also has specific certification and standard requirements for four-wheeled mobility scooters.

CMVR Certification
About Certification: CMVR stands for India’s Central Motor Vehicles Regulation. Its standards committee is CMVR-TSC, which is under the Indian Ministry of Shipping, Road Traffic and Highways. This regulation covers a wide range of key areas, including vehicle design, manufacturing, safety, and environmental protection. It aims to ensure that all vehicles operating on Indian roads meet uniform safety and technical standards, providing a solid foundation for the safety of road users and environmental sustainability. Any vehicle entering the Indian market must strictly comply with this regulation.

Certification Process:
Application Submission: Companies must carefully prepare detailed product information, technical specifications, production process instructions, and other relevant materials, and formally submit a CMVR certification application to the Indian authorities. Application materials must be accurate and complete to avoid delays or issues during the subsequent review process.​
Document Review: The certification body will conduct a comprehensive and detailed review of the documents submitted by the enterprise, carefully checking whether they comply with all requirements of the CMVR regulations. This includes product design drawings, technical specifications, and safety performance specifications. During the review process, the certification body may require the enterprise to supplement or revise relevant information.

Sample Testing: The enterprise must submit samples of the four-wheeled mobility scooters to a laboratory designated by the Indian certification body, or to a domestic laboratory with relevant qualifications and authorized by the Indian certification body for testing. The testing process must be witnessed and supervised by an engineer from the Indian certification body. Testing items cover a wide range of aspects, including vehicle safety (such as braking performance, crash safety, and lighting systems), environmental performance (such as exhaust emissions and noise control), and electrical performance, to ensure that the vehicle fully meets all technical specifications of the CMVR regulations.

Factory Audit: After the sample testing passes, the certification body will dispatch engineers to conduct an on-site inspection of the production plant. The audit covers the factory’s production facilities, quality control systems, personnel qualifications, and production processes. This ensures that the manufacturer has the ability to consistently and stably produce products that meet CMVR standards and that the quality system documentation provided by the company is highly consistent with actual operations.

Certificate Issuance: After a rigorous factory inspection and confirmation that all indicators meet the requirements, the certification body will issue a TAC (Type Approval Certificate) for the vehicle product. Only with this certificate can the vehicle be legally sold in the Indian market.

Subsequent Supervision: After certification, the company is subject to ongoing supervision. Complete vehicles undergo regular COP (Certificate of Production) inspections, conducted annually, and factory audits every two years to ensure continued compliance with certification requirements and maintain product quality.

BIS Certification
About Certification: BIS certification is India’s national certification system, established and supervised by the Bureau of Indian Standards. This certification requires that products undergo comprehensive testing in accredited Indian laboratories and strictly comply with relevant standards. They also undergo rigorous factory inspections by BIS auditors to ensure consistent and stable product quality, safeguarding consumer rights and market order.

Certification Process:

Application Submission: Manufacturers must submit a detailed certification application to BIS, including product specifications, production process flow charts, and quality control manuals. Product samples must also be provided as required for subsequent testing. When applying, please ensure the accuracy of your application by clearly specifying the applicable Indian standards.

Sample Testing: BIS will randomly select a certain number of submitted samples and conduct comprehensive testing in accordance with relevant Indian standards. Testing covers a wide range of areas, including electrical safety (such as insulation resistance and withstand voltage testing), mechanical properties (such as strength and durability), safety (such as protective devices and warning signs), and reliability, to ensure that product quality meets specified requirements.

Factory Inspection: After passing sample testing, BIS may, under certain circumstances, request an on-site inspection of the manufacturing facility. BIS auditors conduct a comprehensive and in-depth assessment of the factory’s production equipment, production environment, raw material procurement management, quality control processes, and personnel training to ensure the factory’s ability to consistently produce standard products and that the production process complies with BIS requirements.

Certification: After passing all tests and passing the audit, BIS will issue a certificate, allowing the manufacturer to use the BIS mark on its products. BIS certification enhances product competitiveness in the Indian market and increases consumer confidence in product quality. At the same time, companies must strictly adhere to BIS regulations and undergo regular supervision and inspections to maintain the validity of the certification.

Requirements in Other Countries and Regions

Certification and standard requirements for four-wheeled mobility scooters for seniors vary across different countries and regions. For example, Japan has unique regulations for low-speed electric vehicles (which typically include four-wheeled mobility scooters for seniors). Vehicles must pass JIS certification, covering items such as an 8 km/h crash test and electromagnetic radiation testing. Batteries must meet JIS C 8715-2 standards, charging ports must be compatible with the CHAdeMO protocol, and each vehicle must be embedded with an RFID chip for full lifecycle traceability.

In Southeast Asia, Thailand implements a “carrot and stick” policy for low-speed electric vehicles. A 25% tariff is levied on imported whole vehicles, but automakers who commit to local production within three years receive subsidies of 70,000 to 150,000 baht per vehicle. Malaysia exempts imported assembled vehicles from 100% sales tax until the end of 2025, but requires battery suppliers to establish local factories. Vietnam adopts a tiered tariff rate, with vehicles with a battery energy density below 100Wh/kg subject to a 105% tariff, while those with a battery energy density above 150Wh/kg are subject to a 5% tariff.

Strategies and Recommendations

Plan Certification Ahead of Time: Given that certification cycles vary across countries and regions, such as the EU EEC certification, which typically takes 50-60 days, and the US FDA certification process, which is more complex and time-consuming, companies should initiate certification efforts at least six months or even a year in advance to allow ample time to resolve potential issues.

In-depth Standard Research: Assign professionals to closely monitor developments in certification standards across countries and regions. For example, the EU updates its “White Paper on New Energy Vehicle Market Access” quarterly, and the Indonesian Ministry of Industry publishes its “Electric Vehicle Industry Development Report” monthly. Companies should stay abreast of this information to ensure their products consistently meet the latest standards.

Localization Strategy: To better meet target market demand and reduce tariff costs, companies may consider establishing local production bases or partnering with local companies. For example, BYD established a factory in Rayong Province, Thailand, which localized the production of motors and electronic controls, effectively reducing tariff costs.

Establish a Comprehensive After-Sales System: Some countries have strict after-sales service requirements. For example, Turkey requires service station registration within 30 days, and Canada stipulates a minimum battery warranty period of eight years. Companies should establish a sound after-sales network in their target markets to ensure timely responses to customer needs and improve customer satisfaction.