Medical network on December 22 - in order to strengthen the supervision and administration of production of medical equipment, regulate the production quality management of medical equipment, according to the regulations on the supervision and administration of medical devices (state council order no. 650), "medical devices supervision and administration of production method" (the state food and drug supervision and administration of administration makes no. 7), the state food and drug supervision and management of administration organization drafted "medical equipment production and the quality control standard for the appendix customised denture", now be released.
This appendix is customised denture production the special requirements of the quality control standard. Customised denture production quality management system shall be in conformity with the medical equipment production and the quality control standard and the requirements of this appendix.
Notice is hereby given that the.
Attachment: medical device manufacturing quality control specification appendix customised denture
The food and drug supervision bureau
On December 16, 2016
Medical equipment production and the quality control standard for the appendix
Customised denture
The first part of the scope and principle
1.1 of this appendix referred to in customised denture refers to according to the medical institutions to provide patients with oral impression, oral cavity model, oral scan data and the product production design, after processed, ultimately for patients to restore, dentition defect and tooth defect teeth loss of form, function and appearance of dental restoration, does not contain the dental implant.
1.2 this appendix is for customised denture production the special requirements of the quality control standard.
The second part of special requirements
2.1 personnel
2.1.1, head of technology, production and quality management shall have relevant professional knowledge on oral repair, and the corresponding practical experience, should have the ability to practical problems in production management and quality management make the right judgment and processing.
2.1.2 personnel engaged in the production should be to master the technology and the requirements for jobs, and received oral prosthetics and other relevant professional knowledge and practical skills training.
2.1.3 full-time inspection personnel should be treated with oral prosthetics and other related professional knowledge training, has the corresponding practical operation skills.
2.1.4 shall conduct with the product quality to affect the health of the staff management,
And to establish health files. Direct contact with the material and product operator check-up at least once a year, infectious, infectious diseases shall not be engaged in direct contact with the work of the product.
2.2 premises and facilities
2.2.1 facilities shall not be located in residential and so on are not suitable for the place of production.
2.2.2 production environment should be clean and sanitary.
2.2.3 casting, sand blasting, plaster and easy to produce dust, easy to pollution area shall be independent setting, and regularly clean. Products on the relatively clean area such as porcelain, cleaning and packaging should be easy to produce dust, easy to pollution area relatively independent.
2.2.4 shall for disinfection, production, inspection, warehousing and other area differentiate, and adapted to production scale, variety.
2.2.5 of inflammable, explosive, poisonous and harmful material shall deposit zone, identification, and issuing special custody.
2.2.6 shall, in the process of production produce the harmful material such as dust, smoke, poison the corresponding protective equipment factory building, equipment installation, take effective protective measures, to ensure that the working environment, personnel protection.
2.3 devices
2.3.1 for by cutting technology (CAD/CAM), material manufacturing technology (3 d printing) in the production of products, shall be equipped with corresponding production equipment, process equipment, and computer aided design and manufacture system.
2.4 procurement
Against 2.4.1 production according to customised denture, the second category of medical device registration shall purchase registered or approved by the food and drug supervision and administration department for the record of the denture of raw materials, its technical indicators should conform to the compulsory standards or certified or registered product technical requirements.
Using unregistered or registered 2.4.2 denture materials produced customised denture according to the third class medical equipment management, and shall have the corresponding production license.
2.4.3 a certified or registered denture material labels and specifications should comply with the regulation on administration of medical equipment manuals and labels, imports of denture materials text labels and instructions shall be kept in the Chinese language.
2.4.4 should choose to have legal qualification of denture raw materials suppliers, check and maintain the supplier qualification certification documents, and establish archives.
2.4.5 should consult, while the metal raw material incoming inspection retained metal raw material production enterprise of the factory inspection report. Factory inspection report should contain the relevant index to the metal elements define the inspection items, such as inspection report cannot cover the relevant index to the limit of metal elements, metal raw materials production enterprises of metal elements should be required inspection qualified indicators, and save the relevant inspection results.
2.4.6 metal raw material production enterprise is unable to provide the relevant index to the limit of metal elements of inspection records, test or no procurement shall be made of metal materials.
2.4.7 shall formulate dental impression, oral model, oral single scan data and design acceptance criteria.
2.5 the production management
2.5.1 product production process procedures and work instructions shall be prepared, clear the key process and special process.
2.5.2 shall explicitly dental impression, oral model and finished product disinfection method, and according to the requirement of disinfection. Product packaging sterilization, rear can leave the factory.
2.5.3 shall establish a receiving area, model artifacts box disinfection regulation, and the production working mesa clean regularly, keep relevant records.
2.5.4 metal tailing add requirements shall be implemented according to the metal raw material production enterprises to provide product manuals.
2.5.5 he shall make provisions for the products in the production of waste after processing, shall conform to the requirements of environmental protection, and keep processing records.
2.5.6 shall mainly denture material balance verification to raw materials, to ensure that the main denture materials actual usage and dosage of theory, within the scope of permissible deviation, if there are any significant differences, must find out the reason.
2.5.7 each product shall have the production records, and satisfies the requirement of traceability. Main denture materials used in the production records shall include the name of the production enterprises, main denture materials, metal brand model, batch/serial number, the main production equipment name or number, operators, etc.
2.6 quality control
2.6.1 each product shall have an inspection records, and satisfies the requirement of traceability. Inspection requirements shall not be less than the mandatory standards and relevant state regulations.
2.6.2 May increase during the process of production or produce harmful metal elements, metal elements shall be in accordance with the requirements of the relevant industry standards for qualified index test.
2.7 sales and after-sales service
2.7.1 should choose to have legal qualification of medical institutions, save the qualification certificate of practice of a medical institution, and establish archives.
2.7.2 shall establish a product sales records, and medical institutions to ensure that product traceability. Sales of the products shall be labelled, inspection certificate, specification and design.
2.8 nonconforming control
2.8.1 should for medical institutions for disinfection, reviews the returned products.
The third part of the term
3.1 is the meaning of the following terms:
Dental impression: refers to the dental impression about the organization, reflects the oral soft and hard tissue associated with the repair.
Oral model: it is to point to by dental impression infusion into the model.
Design sheet: it's written guidance on the customised denture production process, is the production of customised denture before fill in the data documents.
Cutting technology (CAD/CAM), computer aided design and manufacturing technology, mainly used for material removal, cutting processing.
Increase of material manufacturing technology (3 d printing) : is the method that USES material gradually accumulate manufacturing entity parts technology, compared with traditional material removal, the machining technology, is a "bottom-up" manufacturing method.
Metal raw materials: materials with alloy metal catalysts, precious metals, or attribute.
Metal tailing: refers to the investment casting process after casting, cutting the rest of the cast part, base, and the production process of metal casting grinding cutting removal of part, not qualified castings.
Material balance: in due consideration of permissible deviation, under the condition of normal dosage of product or material production or theory with the actual production or consumption between flat.
Harmful elements: the element of known biological effects may be produced.
The fourth part is attached
4.1 of this appendix will be interpreted by the state food and drug administration bureau.
4.2 the appendices shall come into force on January 1, 2018. |
