Regulations on supervision and management of operation, inspection and fitting of orthokeratology lens
Notice of "Regulations on supervision and management of operation, inspection and fitting of orthokeratology lens"
Orthokeratology lens (commonly known as OK lens) is a kind of medical equipment which can correct ametropia by changing the shape of cornea. In view of the fact that problems in the use of OK lenses have occurred from time to time, and even caused certain harm to the wearers, in order to strictly regulate the market behavior, strengthen the supervision and management of OK lenses, and ensure the safety and effectiveness of products, in accordance with the relevant provisions of the regulations on the supervision and administration of medical devices, our bureau has formulated the regulations on the supervision and management of the operation and fitting of orthokeratology lenses, which is hereby printed and distributed Here you are. Please carry it out.
Article 1 in order to strengthen the supervision and management of orthokeratology lenses and ensure the safety and effectiveness of products, these Provisions are formulated in accordance with the regulations on the supervision and administration of medical devices and the measures for the supervision and administration of medical device business enterprises.
Article 2 the term "orthokeratology lens" (commonly known as OK lens) as mentioned in these Provisions refers to the medical equipment used to correct ametropia by changing the shape of the cornea.
Article 3 for the purposes of these Provisions, the term "business entity of orthokeratology lens" refers to the unit with legal person status that supplies orthokeratology lens products to the inspection and fitting institutions as entrusted by the production unit.
Article 4 for the purposes of these Provisions, the term "orthokeratology fitting institution" refers to an institution with legal personality, which directly conducts optometry for ametropic patients and uses orthokeratology lens to correct naked eye vision for the wearer, including the fitting department or professional fitting institution set up by medical institutions.
Article 5 These Regulations shall be observed by the production, operation, fitting institutions, supervision and administration departments of orthokeratology lenses within the territory of the people's Republic of China.
Article 6 orthokeratology lens is a product that directly contacts human cornea. Special management shall be implemented for its operation and fitting. The orthokeratology lenses and nursing products operated and used by the operation and fitting institutions must meet the requirements of relevant national standards (in the absence of national or industrial standards, they must comply with relevant technical specifications), and be registered and approved by the State Drug Administration.
Article 7 according to the provisions of Article 5 of the measures for the supervision and administration of medical device business enterprises, the corneal plastic lens business unit applying for the "medical device business enterprise license" shall not only meet the requirements for the establishment of class III medical device business enterprises, but also meet the following conditions:
（1） The person in charge of the unit shall have a college degree or above, and be familiar with the regulations and rules related to the supervision and management of medical devices.
（2） There should be technical personnel, service personnel and quality inspection personnel of relevant specialties.
（3） It shall be equipped with main inspection equipment and instruments, at least with focimeter, ball diameter meter, lens tester and other equipment.
（4） The corresponding management and inspection system should be formulated and strictly implemented.
（5） The business unit should have the ability of pre-sale service for orthokeratology products. It shall be able to provide adequate product introduction materials to the fitting agency, including the approved product instructions for the wearer.
（6） The business unit should have the ability to provide after-sales service to the orthokeratology lens products. It should be able to collect the adverse reactions of the wearer after wearing orthokeratology lens, effectively handle the wearer's complaints, and keep the relevant records. It shall be able to train the fitting personnel of the selected inspection agency to use the product, and issue training certificate.
Article 8 the State shall implement a record keeping management system after the qualification approval of the production or business unit for the fitting institutions of orthokeratology lenses; the State shall implement the fixed-point sales management of the production or business units to the fitting institutions, and the production or business units can only provide products to the approved fitting institutions.
The business unit shall handle the medical device business enterprise license in accordance with the provisions of the "medical device business enterprise supervision and management measures". The production or business unit shall, in accordance with the relevant requirements of this regulation, recognize and authorize the qualification of the matching agency, sign the responsibility letter, and determine their respective responsibilities in the product after-sales service; the production or business unit and the inspection institution shall go through the filing procedures with the local provincial drug administration before the inspection institution can carry out the matching business. If the inspection agency violates the provisions, the production and business units that approve and authorize their qualifications shall bear corresponding responsibilities.
Article 9 an inspection institution shall meet the following requirements:
（1） The matching personnel should be ophthalmologists or optometrists with intermediate title or above; before engaging in the matching business, they should obtain the corresponding authorization according to the requirements of the product production and business unit.
（2） The total area of the fitting site shall not be less than 45 square meters. It shall be equipped with reception room, examination room, optometry room and wearing room, etc., with good environmental and sanitary conditions.
（3） It should be equipped with corresponding matching equipment, at least including: corneal curvature meter, corneal topography meter (measuring range of diameter above 8mm), non-contact tonometer, corneal thickness meter, computer refractometer, comprehensive refractometer, refractor box, slit lamp microscope, near / far vision chart, ophthalmoscope, fundus mirror, sodium fluorescein test paper, focimeter, lens projector (not less than 7.5 times) And lens radian tester.
（4） The inspection organization shall formulate corresponding rules and regulations and strictly implement them.
Article 10 the inspection institutions shall have strict management standards for inspection and matching.
（1） To make the wearer fully understand the relevant knowledge of orthokeratology lens, including: principle of action, clinical application results, lens correction effect, use of lens in maintenance period, wearing risk, contraindications and precautions, alternative methods of myopia correction, etc.
（2） All wearers should take necessary examinations related to ophthalmology and orthokeratology. In addition to routine examination of ophthalmic slit lamp, the following items should be included: corneal morphology, corneal thickness, ocular axis, intraocular pressure, eye position, distant / near visual acuity, diopter, tear test, corneal diameter, pupil diameter, fundus examination, and determine whether they are suitable for wearing orthokeratology according to the examination data.
（3） Try on the lenses before wearing them for the first time, and observe and evaluate the fitting state.
（4） According to the examination data and evaluation results, the fixation parameters and wearing scheme were designed.
（5） It is necessary to provide the wearer with guidance after wearing glasses, including precautions, possible adverse reactions, personal hygiene requirements, lens wearing operation, lens care routine, use of nursing products and lens box, handling of side effects and emergencies, etc., and provide instructions for use.
（6） It is necessary to establish files for all wearers and keep the fitting and review records to ensure the traceability of products. The storage period is 5 years.
（7） The follow-up review should be carried out at least 7 times within 6 months before follow-up. The review contents include diopter, visual acuity, mobility, central positioning, comfort, fluorescein staining, corneal topography and intraocular pressure.
Article 11 business units and inspection institutions shall provide product instructions approved by the State Drug Administration, which shall at least include:
（1） Objective to introduce the principle of orthokeratology lens objectively and truthfully, and explain that the function of orthokeratology lens is temporary and limited, and the curative effect is reversible.
（2） Make clear the scope of vision correction and the suitable population.
（3） The contraindications were clear.
（4） Inform the wearer of possible reactions or symptoms, such as eye irritation, itching, discomfort, feeling of foreign body or rubbing in the eye, red eye, fear of light, abnormal secretion, etc.; inform the wearer of the measures to be taken in case of inappropriate situation, such as: take off the lens and go to the hospital in time.
（5） Clear the cleaning, disinfection and nursing solution used with the product.
Article 12 the business unit and the fitting inspection institution shall be responsible for guiding the examiners to use the orthokeratology lens and nursing products correctly. It is forbidden to sell and use orthokeratology lens and nursing products without medical device registration certificate.
Article 13 business units and fitting agencies shall ensure that the products and labels of orthokeratology lenses ordered by the manufacturer to the fitting institutions and even to the wearers have unique traceability. The business unit shall work out a triplicate sheet of "responsibility statement for the use of orthokeratology lens" with the production unit, and provide it to the fitting agency along with the product. Before fitting the orthokeratology lens, the wearer should read the contents of the triplet and sign with the fitting personnel. The triplicate sheet shall be stamped with the seal of the business unit and the inspection organization. After the fitting, the wearer, the fitting agency and the business unit shall each keep one copy of the triplet. The contents of the triplet should include: the wearer's name, gender, age, fitting date, fitting agency, fitting personnel, main identification data of the wearer's eye test, product name, specification, number, identification mark, production unit, business unit, registration number, responsibilities of all parties, and signature of the fitting personnel and wearer.
Article 14 the trial wearing lenses provided by the business unit to the inspection institutions shall be submitted to the inspection center designated by the State Drug Administration for testing.
Article 15 the production, operation and use of orthokeratology lens products shall strictly implement the quality accident reporting system. If any quality accident is found in the use of the product, the production, business unit and inspection institution shall report to the local drug supervision and administration department in a timely manner.
In case of any adverse reaction due to the use of orthokeratology lens, the manufacturer, business unit, fitting institution and wearer shall report to the local drug supervision and administration department for adverse reaction monitoring in time.
Article 16 when a product quality accident occurs, the production and trading units and the testing and dispensing institutions must cooperate with the pharmaceutical supervisory and administrative department in the investigation, analysis and handling of the accident.
Article 17 those who violate the above provisions shall be punished in accordance with the regulations on the supervision and administration of medical devices and other relevant regulations.
Article 18 the market supervision department of the State Drug Administration shall be responsible for the interpretation of these provisions.
Article 19 These Provisions shall come into force as of the date of promulgation.