Article 1 In order to strengthen the supervision and management of keratoplasty lenses, to ensure product safety and effectiveness, according to the "supervision and management of medical devices regulations", "supervision and management of medical equipment business enterprises", the formulation of these provisions.
Second The corneal plastic lenses (commonly known as OK lenses) referred to in these provisions refers to the shape of the cornea to correct refractive error by changing the medical device.
Article 3 The provisions of the corneal plastic lenses business unit, refers to the production unit entrusted to the fitting institutions to supply corneal plastic lenses, with legal personality of the unit.
Article 4 The keratoplasty lenses testing and dispensing institutions referred to in these provisions, refers to the direct refractive error for the patients to check the optometry, the use of keratoplasty lenses for the wearer to correct the naked eye vision, with legal person qualification of the institutions, including medical institutions set up by the testing and dispensing department or professional testing and dispensing institutions.
Article 5 In the People's Republic of China **** and the territory of the corneal plastic lenses production, operation, fitting institutions, supervision and management shall comply with these provisions.
Article VI keratoconus is a direct contact with the human cornea products, its operation, testing and dispensing need to implement special management. Management, testing and dispensing organizations operating, the use of keratoplasty lenses and care products must meet the requirements of the relevant national standards (in the absence of national standards or industry standards, must comply with the relevant technical specifications), approved by the State Drug Administration registration.
Article VII Based on the "supervision and management of medical equipment business enterprises" Article V of the provisions of the corneal reshaping lenses business unit to apply for a "medical device business license" in addition to the third category of medical devices should meet the conditions for the start-up of business enterprises, should also have the following conditions:
(a) the person in charge of the unit should have college education, familiar with the supervision and management of medical devices and regulations and laws. regulations.
(ii) should have relevant professional technicians, service personnel and quality inspection personnel.
(3) It should have the main inspection equipment and instruments, at least it should have the equipment such as pyrometer, spherical diameter meter and lens checker.
(d) should develop appropriate management and inspection system, and strictly enforced.
(e) The business unit should have the ability to pre-sale services for keratoconus products. Should be able to provide adequate product introduction information to the fitting organization, including providing the wearer with an approved product instruction manual.
(f) The business unit shall have the ability to provide after-sales service for corneal reshaping lenses. Should be able to collect the wearer after wearing keratoplasty lenses adverse reactions, effectively deal with the wearer's complaints, and keep records of the relevant processing. It shall be able to train the dispensers of the selected dispensing organizations in the use of the products and issue training certificates.
Article 8 The State shall implement a filing management system for the production or operation units after the qualification recognition of the corneal plastic lenses fitting institutions; the production or operation units shall implement the management of fixed-point sales to the fitting institutions, and the production or operation units can only supply the products to the fitting institutions recognized by them.
The operating unit shall apply for the "Medical Device Business Enterprise License" in accordance with the provisions of the "Supervision and Administration of Medical Device Business Enterprises". Production or business units should be in accordance with the relevant requirements of the provisions of the qualifications of the fitting institutions recognized and authorized to sign a letter of responsibility to determine their respective responsibilities in the after-sales service of the product; production or operation of the unit, fitting institutions should be respectively to their respective local provincial Drug Administration for the record, the fitting institutions can carry out fitting business. Such as fitting institutions in violation of the provisions of its qualifications for recognition of the authorization of the production and operation of the unit shall bear the corresponding responsibility.
Article IX fitting institutions should have the following conditions:
(a) fitting personnel should be intermediate title or above ophthalmologist or optometrist; in the fitting business, should be in accordance with the requirements of the product production and operation units to obtain the appropriate authorization.
(2) The total area of the fitting site shall not be less than 45 square meters, with reception room, examination room, optometry room and fitting room, etc., as well as good environmental and hygienic conditions.
(3) should be equipped with appropriate fitting equipment, at least should include: corneal curvature meter, corneal topographer (more than 8mm diameter measurement range), non-contact intraocular pressure meter, corneal thickness meter, computerized optometry, comprehensive optometry, optometry test case, slit lamp microscope, far\near vision meter, examining glasses, funduscopic lenses, sodium fluorescein test strips, focal length meter, lens projector (not less than 7.5 times), lens projector (not less than 7.5 times), lens projector, lens projector (not less than 7.5 times), lens projector (not less than 7.5 times), lens projector (not less than 7.5 times), lens projector (not less than 7.5 times). times), lens curvature tester, etc.
(d) the dispensing organization should develop appropriate regulations and strictly enforced.
Article X. The dispensing organization shall have strict management standards for dispensing.
(1) To enable the wearer to fully understand the relevant knowledge of keratoplasty lenses, including: the principle of action, the results of the current state of clinical use, the corrective effect of the lenses, the use of lenses during the maintenance period, the risks of wearing, contraindications and precautions, and other alternative methods of correcting myopia, and so on.
(2) All wearers should undergo the necessary examinations related to ophthalmology and keratoplasty lenses, which, in addition to the routine ophthalmologic slit-lamp examination, should include: corneal morphology, corneal thickness, intraocular axes, intraocular pressure, ocular position, distance/near vision, refractive error, tear test, corneal diameter, pupil diameter, and funduscopic examination, and based on the examination data, determine whether they are suitable for the use of keratoplasty lenses.
(3) A fitting assessment should be carried out before the first fitting of lenses and the final fitting to observe and assess the fit status.
(d) Design the parameters of lens fixation and the fitting program according to the examination data and the results of fitting assessment.
(e) must provide the wearer with instructions on the use of lenses after fitting, including: precautions, possible adverse reactions, personal hygiene requirements, lens fitting operations, lens care routine, use of care products and lens cases, side effects and emergency treatment, etc., as well as instructions on the use of lenses.
(F) must set up files for all wearers, keeping records of fitting and review to ensure product traceability, and the retention period is 5 years.
(vii) The time of follow-up review is at least 7 times in the first 6 months or less, and regularly after 6 months, the review includes: refraction, visual acuity, mobility, centration, comfort, fluorescein staining, corneal topography, intraocular pressure.
Article XI of the operating units and fitting institutions shall provide the product instruction manual approved by the State Drug Administration, the contents of the manual at least include:
(a) objectively and truthfully introduces the corrective principle of keratoplasty lenses, and explains that the role of keratoplasty lenses is temporary and limited, and the efficacy of the treatment is reversible.
(ii) Specify the scope of vision correction and the population to which the product is applicable.
(c) Clarify contraindications, precautions.
(4) Inform the wearer of possible reactions or symptoms, such as: eye irritation, itching, discomfort, foreign body sensation or abrasion sensation in the eyes, redness in the eyes, fear of light, abnormal secretions, etc.; Inform the wearer of the measures that should be taken in the event of discomfort, such as: removing the lenses, and go to the hospital in time for medical treatment.
(E) Clearly with the product supporting the use of cleaning, disinfection and care solution.
Article XII of the operating units and fitting institutions have the responsibility to guide the correct use of keratoconus lenses and care products. It is strictly prohibited to sell or use corneal reshaping lenses and care products without medical device product registration certificate.
Article XIII of the operating units and fitting institutions shall ensure that from the production unit to order keratoconus products to the fitting institutions, up to the wearer, the product and the logo has a unique traceability. The operating units shall formulate with the production units the "Responsibility for the Use of Corneal Plastic Lenses" triplicate form, which is provided to the fitting institutions together with the products. The wearer should read the content of the triplicate form and sign it with the dispenser*** before the fitting of keratoplasty lenses. The seal of the operating unit and the fitting organization should be stamped on the triplicate form. After examination and dispensing, the triple bill shall be collected and stored by the wearer, the dispensing organization and the operating unit. The content of the triplicate list should include: the wearer's name, gender, age, date of fitting, fitting organization, fitting personnel, the main identification data on the wearer's eye test, product name, specifications, number, identification mark, production unit, business unit, registration number, the responsibility of all parties, fitting personnel and the wearer's signature.
Article XIV of the operating unit provided to the fitting agency to try on the lenses, should be sent to the State Drug Administration designated testing center sample testing.
Article XV of the production, operation and use of keratoconus products should be strictly enforced quality incident reporting system. Production, management units and fitting institutions such as the product found in the use of quality accidents, should be promptly reported to the local drug supervision and management department.
Adverse reactions due to the use of keratoplasty lenses, production, operation units, fitting institutions and wearers should be promptly reported to the local drug supervision and management department commissioned by the adverse reaction monitoring department.
Article XVI of the product quality accidents, production, management units and fitting institutions must cooperate with the drug supervision and management departments to investigate, analyze and deal with the accident.
Article XVII keratoconus production, management units and fitting institutions in violation of the above provisions, in accordance with the "Supervision and Administration of Medical Devices Regulations" and other relevant regulations shall be punished.
Article XVIII of these provisions by the State Drug Administration of the Department of Market Supervision is responsible for the interpretation.
Article 19 These provisions shall be implemented from the date of publication.