DYM’s one-stop high-end dental equipment shares with you the standards for the acceptance of dental clinics (oral clinics) by the Health and Health Bureau as follows

When applying for a “Medical Institution Practice License”, it is necessary to pass the acceptance of the local Health and Health Bureau (Health and Health Bureau) and meet the national and local opening standards. The following are the core acceptance conditions for dental clinics (taking China’s general requirements as an example, the specific requirements need to be combined with the local Health and Health Bureau’s rules):

I: Basic qualification requirements for dental clinics:

1. Institutional qualifications

Obtain the “Medical Institution Establishment Approval” (establishment approval stage).

Submit the “Medical Institution Practice Registration Application Form”.

II: The legal person/person in charge of the dental clinic must have an oral category “Doctor Qualification Certificate” and “Doctor Practice Certificate” (a private clinic can be set up after practicing for 5 years).

2. Staffing for the opening of a dental clinic

At least 1 practicing physician: the attending physician must be registered in the institution, and the scope of practice includes “oral profession”.

Oral nurse: At least 1 registered nurse (oral care training certificate is required).

X-ray machine radiation personnel (such as CBCT room): must hold a “Radiation Staff Certificate”.

2. The site and layout of dental clinics

1. Area requirements for dental clinics

General dental treatment room: the net usable area of each dental chair is ≥9㎡ (single room) or ≥6㎡ (partitioned).

Total building area of dental clinics: usually ≥40㎡ (large differences in different places, such as ≥80㎡ in Shanghai).

2. Functional zoning is required for the opening of dental clinics

Required areas: oral treatment room, implant room, cleaning room, disinfection room, packaging area, waiting area, positive and negative pressure room equipment area, CBCT area, various dentist preparation areas, technician polishing area, toilet area, laundry area, temporary storage of medical waste, etc.

Optional areas: X-ray room (separate lead protection required), technician room, sterile storage room.

3. Infection control layout of dental clinics

Three-zone division: contaminated area (treatment area), clean area (disinfection area), sterile area (storage area), with clear markings.

Disinfection room of dental clinic: It needs to be equipped with double-slot cleaning pool or fully automatic disinfection equipment, and the dryer and water line need to be separated.

III. Equipment configuration standards for dental clinics:

1. Comprehensive dental treatment chair:

At least 1 unit, in accordance with the YY/T 0753 anti-respiration standard, and a medical device registration certificate is required.

2. Disinfection and sterilization equipment:

Such as high-temperature and high-pressure sterilizer (Class B), ultrasonic cleaning machine, sterilization packaging bag (biological monitoring records are required).

3. First aid equipment:

Such as oxygen cylinder/oxygen concentrator, first aid medicine (epinephrine, etc.), AED (required in some areas).

4. Radiation equipment:

If a dental film machine/CT is set up, a “Radiation Diagnosis and Treatment License” must be obtained, and the wall lead protection ≥2mm lead equivalent.

5. Other dental auxiliary equipment

Such as light curing machine, tooth cleaning machine, saliva suction system, implant machine, root canal preparation machine, oral endoscope, mobile phone cleaning and oiling machine, distilled water machine, anesthesia treatment device, sealing printer, etc., need to function normally and be calibrated regularly.

IV. Infection control and medical waste management in dental clinics

1. Disinfection system of dental clinics

Implement the “Technical Specifications for Sterilization and Disinfection of Oral Instruments” (WS 506-2016).

Dental mobile phones, dental needles, etc. are sterilized after one person uses them, and the sterilization date, expiration date and operator are recorded.

2. Medical waste treatment in dental clinics

Classify and store in special containers (sharp boxes, infectious waste bags).

Sign a recycling contract with a qualified medical waste company and keep the transfer form for at least 3 years.

3. Water quality requirements for dental clinics:

The waterway of the dental chair needs to be disinfected regularly (rinsed weekly and tested quarterly), and the total bacterial count is ≤100 CFU/mL.

V. Daily management system and documents of dental clinics

1. Necessary system documents

Infection prevention and control plan, medical waste management system, emergency procedures, patient privacy protection system.

2. Personnel file management of dental clinics

Professional certificates, training certificates, and health certificates (including five hepatitis B tests) of all medical staff.

3. Equipment file management of dental clinics

4. Certificates and maintenance records of dental chairs, sterilizers, oral endoscopes, positive and negative pressure room equipment (compressors, negative pressure suction machines, sewage treatment machines), LED light curing machines, CBCT and other equipment.

5. Dental positive and negative pressure rooms need to operate separately, and both positive and negative pressure machines need to open fresh air windows to eliminate odors. Remember that positive and negative pressure rooms should not have the same exhaust port to avoid cross infection.

VI. Acceptance process of dental clinics

1. Submit materials

Property certificate/lease contract, floor plan, equipment list, copies of personnel qualifications, etc.

2. On-site inspection of dental clinics

The expert group of the Health and Health Bureau will conduct on-site inspections of layout, equipment, infection control, etc., and may simulate the operation process.

3. Rectification and issuance of licenses

Rectification of unqualified items will be carried out within a time limit, and the “Medical Institution Practice License” will be issued after the review is passed.

VII: Suggestions on how to avoid pitfalls when opening a dental clinic

Advance consultation: Contact the local Health and Health Bureau’s Medical Administration Section directly to obtain the latest acceptance standard documents.

Review before decoration: Submit the decoration design drawings for pre-examination to avoid rework (such as insufficient area of the disinfection room).

Provide third-party guidance: You can hire a medical qualification agency to assist (the cost ranges from about 10,000 to 50,000 yuan).

Strict preparation in accordance with the standards can avoid acceptance failures and delays in opening time. It is recommended to reserve 1-2 months for rectification and approval processes.

DYM’s one-stop high-end dental equipment can plan the site on-site 24 hours a day in the Pearl River Delta region. It can effectively avoid site planning risks according to the requirements of the Health and Health Bureau, and can provide dental equipment in a one-stop manner, greatly improving the procurement timeliness of various dental clinics and oral hospitals.