What Qualifications Are Required to Sell Dental Equipment in China?

Shared by DYM – Your One-Stop High-End Dental Equipment Partner

If you wish to distribute or act as an agent for dental equipment in China, what qualifications and licenses do you need?
DYM Medical, a one-stop high-end dental equipment manufacturer, shares the essential qualifications required to engage legally and effectively in the Chinese dental equipment market.

Qualification 1: Business Registration and Legal Compliance

You must hold a valid Business License that explicitly lists business scopes such as “Medical Device Distribution” or “Dental Equipment Sales.”
It is recommended to obtain a unified “Three-in-One” business license (combining business, tax, and organization codes) to avoid administrative issues during tenders or cooperation.
The license should specify whether your company is authorized to operate Class I, II, or III dental devices or dental consumables.
The legal representative must have no major legal violations in the past three years, must not be listed on “Credit China” as a dishonest executor, and must not appear on any government blacklist for serious violations.
Some manufacturers may require submission of a credit report as supporting documentation.

Qualification 2: Medical Device Operating License or Filing

To sell dental devices, you must apply for approval from your local Food and Drug Administration (FDA) and obtain the appropriate Medical Device Operating License or Record Filing Certificate, depending on the risk classification of the device.

Class I Devices

No license or filing required — a valid Business License is sufficient.
Examples: Dental air compressors, suction units, intraoral cameras, handpiece lubrication machines, dental sewage treatment units, and pure water machines.

Class II Devices

Require a Medical Device Record Filing Certificate .
You must submit documentation for the business premises, quality management system, and operational procedures.
Examples: Dental chairs, high- and low-speed handpieces, LED curing lights, endodontic motors, ultrasonic scalers, diamond burs, anesthetic delivery units, and sterilizers.

Class III Devices

Must obtain a Medical Device Operating License .
Additional requirements include:
- A computerized tracking system for product traceability
- Qualified quality management personnel (relevant academic background or certification)
The license is valid for 5 years and must be renewed 6 months before expiration.
Examples: Dental implant systems, CBCT scanners, intraoral scanners, and certain sterilization equipment (code 6857).

Qualification 3: Product Registration Certificates

The products you represent must have valid Medical Device Registration Certificates issued by the National Medical Products Administration (NMPA) — for domestic products, this is the PRC Medical Device Registration Certificate; for imported products, the Import Medical Device Registration Certificate.
All accessory components must also have corresponding filings.
If you represent measuring instruments (e.g., dental X-ray units), you must also hold a CMC Manufacturing License or CPA Approval Certificate.
Non-medical dental materials (e.g., dental modeling compounds) must be accompanied by a classification statement or official determination from the regulatory authority.

Qualification 4: Authorization and Distribution Rights

Distributors must obtain official authorization letters from the manufacturer, specifying the authorized region, product scope, exclusivity status, and authorization period.
For imported products, distributors must hold a complete chain of authorization — from the national general agent to secondary and tertiary distributors — ensuring traceability and compliance.

Qualification 5: Operational Capability and Resource Requirements

To qualify as a distributor or agent of dental devices, you must demonstrate financial capacity, facilities, technical capabilities, and market resources.

Financial Strength – sufficient working capital to cover initial inventory, logistics, marketing, and staffing costs.
Manufacturers typically require RMB 500,000 – 5,000,000 in available capital.
Business Premises – at least 50 m² of office space and compliant warehousing.
If using third-party storage, provide a warehouse entrustment agreement. Cold storage facilities must meet temperature control standards.
Professional Team –
- Quality management personnel (pharmacy or medical background)
- Technical service personnel (responsible for installation and maintenance)
- Sales staff trained and certified by the manufacturer
- After-sales capability to ensure ≤24-hour service response, especially for hospital clients
Market Network and Experience –
- Access to local dental clinics, hospitals, and dental departments
- Experience in dental or medical device sales preferred
- Ability to conduct academic promotions, product demonstrations, and training sessions

About DYM Medical

Founded on December 24, 2007, Foshan Duo Yimei Medical Instrument Co., Ltd. focuses on R&D, manufacturing, sales, and service of professional dental equipment.
Its products are widely used in dental hospitals, private clinics, and dental schools.
Main products include dental treatment units, high- and low-speed handpieces, dental sewage treatment systems, oil-free silent compressors, intraoral cameras, LED curing lights, suction systems, handpiece maintenance machines, and diamond burs, among others.

Under the leadership of Chairman Mr. Li Chengjun, DYM has grown into a Vice President Member of the Foshan Dental Association, High-Tech Enterprise, ISO9001 / ISO13485 / ISO14001 / ISO45001 / CE certified manufacturer, and IP Management Standard Unit.
The company holds 6 Class II medical device certificates, 4 Class I certificates, 5 high-tech product titles, 5 invention patents, 45 utility model patents, 25 design patents, and 21 software copyrights.

With over 18 years of manufacturing experience and participation in more than 350 domestic and international dental exhibitions, DYM is committed to bringing high-quality dental products from China to the world.
Its young and dynamic team (average age 30, core staff with over 8 years of experience) spans mechanical design, electronics, after-sales, marketing, social media, overseas sales, production, quality, logistics, finance, and legal departments — providing comprehensive support for dental professionals.

DYM’s products are now exported to South America, the Middle East, Central Asia, and Southeast Asia, with partnerships established with over 1,500 distributors worldwide.
DYM continues to pursue its mission: to become a globally trusted dental brand and let the world witness the power of Chinese innovation.