Prescription glasses and hearing aids look like consumer goods, but legally both are medical devices in Vietnam. A foreign investor opening an optical chain or distributing hearing aids therefore faces two layers of rules: product circulation conditions under Decree 98/2021/ND-CP, and the line between pure retail and medical measurement services at the point of sale.
Legal basis
- Decree 98/2021/ND-CP on medical device management: risk classification, circulation registration, business and import conditions for medical devices.
- Law on Medical Examination and Treatment 15/2023/QH15 and Decree 96/2023/ND-CP: applicable where the shop performs eye or hearing measurement of a medical nature.
- Decree 342/2026/ND-CP: distribution rights and retail establishment licensing for foreign-invested enterprises selling through stores.
Product conditions: both are medical devices
Corrective eyewear and hearing aids are managed as medical devices: before circulation in Vietnam, a product must be classified by risk group and hold a circulation registration number or circulation number under the corresponding regime of Decree 98/2021/ND-CP, with technical dossiers, Vietnamese sub-labels and user instructions. The registration holder is responsible for quality, traceability and defective-product handling. Distributors must source from holders of valid circulation numbers, store products under manufacturer conditions and maintain distribution records for traceability on regulator demand. Parallel imports bypassing the registration holder are the most common seizure and penalty risk in this product group.
Does the shop need a medical license?
The answer depends on whether the shop performs measurement services. Pure retail of finished glasses against an existing prescription and of registered hearing aids is medical-device trading and needs no medical practice license; the enterprise registers the business lines, meets medical-device trading facility conditions and, for a foreign investor opening retail points, completes the retail establishment licensing under the current distribution framework. By contrast, when the shop measures refraction to generate a customer prescription, or examines and advises on hearing, that activity is medical in nature: it must be performed by appropriately certified personnel within a licensed medical facility or an operating model accepted by the health authority. Many foreign optical chains choose the safe structure: a separate entity, or a partnership with a licensed eye or ENT clinic, for measurement, with the store only retailing against measurement results.
What certificates do consultants need?
Sales staff who advise on frame selection and instruct hearing-aid use are not medical practitioners and need no practice license, but the enterprise must ensure they are product-trained and do not cross the advice boundary: no refraction measurement producing a prescription, no diagnosis of eye or ear disease, no treatment efficacy promises. Personnel performing refraction and professional procedures must hold a practice certificate or professional certificate in refraction under medical practice law, and appear in the personnel dossier of the responsible medical facility. This boundary should be written into store SOPs, because inspectors distinguish the two staff groups precisely by actual job content.
Any special requirements for importing hearing aids?
Imported hearing aids must hold a Vietnamese circulation number before customs clearance under the medical device regime; the import dossier includes circulation evidence, authorisation from the foreign owner to the Vietnamese registration holder, and technical documents evidencing amplification parameters and electromagnetic safety against declared standards. The importer must be an establishment meeting medical-device trading conditions and bears after-sales duties: fitting, warranty and spare parts throughout the life of products sold. Where the model bundles long-term hearing fitting services, the enterprise should plan in advance for customer record retention and health-data confidentiality arising from measurement and fitting.
Frequently asked questions
What conditions apply to foreign-invested optical and hearing-aid businesses?
Products must be classified medical devices holding circulation registration under Decree 98/2021/ND-CP; the enterprise registers medical-device trading, ensures storage, traceability and after-sales conditions, and FDI retail points follow the retail establishment procedure.
Is a medical license required?
Not for pure retail against existing prescriptions. If the shop measures refraction or hearing to generate customer parameters, that service is a medical activity and must sit within a licensed medical facility with appropriately certified personnel.
What certificates do consultants need?
Sales and product consultants need no practice license but must be trained and must not measure or diagnose. Refraction and professional procedures require a practice or professional certificate in refraction and inclusion in the responsible facility personnel dossier.
Are there special requirements for importing hearing aids?
A Vietnamese circulation number before import, authorisation from the foreign owner, technical documents against declared standards, and an importer meeting medical-device trading conditions with fitting and warranty responsibility after sale.
This article has been quality-reviewed by the FLAW AI Legal Council