Chapter 1 General Principles
Article 97. Manufacturers of medical devices (hereafter referred to as the manufacturers) shall comply with regulations of this Part. However, where the Medical Device Management Measures or other relevant laws or regulations apply, compliance with this Part may be waived.
Article 98. Terms used in this Part are defined as follows:
(1) Active medical device: any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;
(2) Active implantable medical device: any active medical device that is totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and that is intended to remain after the procedure;
(3) Implantable medical device: any medical device that is totally or partially introduced by surgical means into the human body or a natural orifice, or to replace an epithelial surface or the surface of the eye, that is intended to remain after the procedure for at least 30 days, and that can only be removed by medical or surgical intervention;
(4) In-vitro diagnostic device: any medical device that is a reagent, instrument, or system used for the collection, preparation and examination of specimens from the human body for use in the diagnosis of disease or other conditions (including determination of the state of health);
(5) Customer complaint: any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market;
(6) Advisory notice: supplementary information or advice issued by the manufacturer upon delivery of a medical device, regarding the use, modification, return or destruction of said device, for the purpose of taking corrective or preventive action or complying with regulatory requirements;
(7) Risk analysis: the investigation of available information to identify hazards and assess risks.
Article 99. Manufacturers of medical devices that fall under the Class 1 category as defined in Attachment 2 of the Medical Device Management Measures, unless said devices must be sterile, are not required to comply with regulations of this Part.
Where medical devices that must be sterile, as described in the preceding Paragraph, are Class 1 or Class 2 medical devices that have been granted a five-year grace period by the central competent health authority, the manufacturers of said products shall come into compliance with regulations of this Part by June 21, 2005.
Chapter 2 Management Responsibility
Article 100. Manufacturers shall clearly establish quality policies, including objectives for, and commitment to, quality.
The quality policies described in the preceding Paragraph shall be relevant to manufacturers’ organizational goals and the expectations and needs of their customers.
Manufacturers shall ensure that these quality policies are understood, implemented and maintained at all levels of the organization.
Article 101. Manufacturers shall clearly define and document the responsibility, authority and interrelation of personnel who manage, perform and verify work affecting quality, particularly personnel who need the organizational authorization to perform the following tasks:
(1) Initiate action to prevent the occurrence of any nonconformities relating to products, process or quality system;
(2) Identify and record any problems relating to products, process or quality system;
(3) Initiate, recommend or provide solutions through designated channels;
(4) Verify the implementation of solutions;
(5) Control further processing, delivery or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.
Article 102. Manufacturers shall identify resource requirements and provide adequate resources, including the assignment of trained personnel for management, performance of work and verification activities including internal quality audits.
Article 103. Manufacturers shall appoint a member of their own management team who, irrespective of other responsibilities, shall define authority for the following tasks:
(1) Ensuring that a quality system is established, implemented and maintained in accordance with regulations of this Part;
(2) Reporting on the performance of the quality system to the management for review and as a basis for improvement of the quality system;
(3) Ensuring the safety and effectiveness of manufactured medical devices.
Article 104. Manufacturers shall review their quality systems at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this Part and the manufacturer’s stated quality policies and objectives. Records of said reviews shall be kept and maintained.
Chapter 3 Quality Systems
Article 105. Manufacturers shall establish, document and maintain quality systems as a means of ensuring that products conform to specified requirements.
Manufacturers shall prepare a quality manual covering the requirements of this Part; said manual shall include or make reference to the quality system procedures and outline the structure of the documentation used.
Article 106. Manufacturers shall adhere to the following quality system procedures:
(1) Prepare documented procedures consistent with the quality policy and the requirements of this Part;
(2) Effectively implement the quality system and its documented procedures.
The quality system procedures described in the preceding Paragraph shall be dependent upon the complexity of the work, the methods used, and the training required by the personnel involved.
Article 107. Manufacturers shall establish in writing a quality plan detailing how quality requirements are to be met.
The quality plan described in the preceding Paragraph shall be consistent with the requirements of manufacturers’ quality systems, and shall be documented in a format to suit the supplier’s operation. Manufacturers shall give consideration to the following activities, as appropriate, in meeting specified requirements for products, projects or contracts:
(1) Preparation of quality plans;
(2) The identification and acquisition of any controls, processes, facilities, (including inspection and test facilities), fixtures, resources and skills that may be needed to achieve the required quality;
(3) Ensuring the compatibility of the design, the production processes, installation, servicing, inspection and test procedures and the applicable documentation;
(4) The updating, as necessary, of quality control, inspection and testing techniques, including the development of new instruments;
(5) The identification of any measurement requirement involving capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed;
(6) The identification of suitable verification at appropriate stages in the realization of products;
(7) The clarification of standards of acceptability for all features and requirements, including those that contain a subjective element;
(8) The identification and preparation of quality records.
Manufacturers shall establish and maintain medical device manufacturing procedure, installation and maintenance files, or a location where relevant information can be accessed. Said files or information shall include product specifications and quality system requirements (including process and quality assurance) for each product type or model.
0 Response to "Good Manufacturing Practices for Medical Devices "
Post a Comment