Quality
Most assistive products are regulated and inspected by the State Administration for Market Regulation (SAMR), the national government agency responsible for overseeing market regulation, product quality and fair competition. Some assistive products, such as manual wheelchairs and hearing aids, are also classified as medical equipment and therefore receive additional regulations and inspections by the National Medical
11Products Administration (NMPA), China's regulatory authority responsible for the supervision and administration of drugs, medical devices and cosmetics.
National quality standards have been developed for all key assistive products. Many assistive product standards in China are primarily developed based on ISO standards with equivalent application. Core parameters, such as fatigue testing criteria, generally maintain consistency with ISO standards, incorporating only minor adaptations for Chinese conditions and needs. For example, some products may require slight modifications to account for anthropometric differences between Asian and Western populations or local usage environments.
Table 2: Quality management of different assistive products in China3
| Product category | Classified as assistive product? | Classified as medical equipment? | Illustrative national quality standards |
|---|---|---|---|
| Spectacles | Yes for low vision No for myopia and presbyopia | No for myopia and presbyopia |
|
| Hearing aids | Yes | Yes, Class II medical device |
|
| Wheelchairs | Yes | Yes, manual wheelchair is Class II medical device |
|
| Prostheses | Yes | No |
|
3.Details for each product can be found in the following respective sessions.↩︎
Regarding international certifications, approximately 70 per cent of survey respondents report having attained one or more international certifications. The table below summarizes the key certifications obtained. Over half of the respondents have Europe CE, ISO 9001, or ISO 13485 certification, and around one-fourth have obtained US FDA approval.
Table 3: The international certifications held by survey respondents
