Schedule M-III

Schedules: Schedule ASchedule BSchedule CSchedule DSchedule E1Schedule FSchedule GSchedule HSchedule H1, Schedule I, Schedule JSchedule KSchedule L1Schedule MSchedule M1Schedule M2Schedule M3Schedule NSchedule OSchedule PSchedule QSchedule RSchedule SSchedule TSchedule USchedule V, Schedule W, Schedule XSchedule Y


Schedule M-III (Rule 69,69A, 75,75A and 76):
Schedule M-III describes the quality management system for notified medical devices and in vitro diagnostics.
1.       General Requirements
2.       Applicability
3.       Term and definitions
§  Active implantable medical device
§  Active medical device
§  Advisory Notice
§  Customer Complaint
§  Implantable medical device
§  Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly
§  Design inputs means
§  Design output means
§  Design review means
§  Finished device means
§  In-vitro Diagnostic means
§  Management with executive responsibility means
§  Medical device referred
§  Quality audit means
§  Quality policy means
§  Quality system means
§  Rework means
§  Specification means
§  Validation means i)Process validation means ii) Design validation means
§  Verification means
4.       Quality management system
§  General
§  Documentation requirements
·         General
·         Quality Manual
·         Control of documents
·         Control of records
5.       Management responsibility
§  Management commitment
§  Customer focus
§  Quality policy
§  Planning
·         Quality objectives
·         Quality management system planning
§  Responsibility, authority and communication
·         Responsibility and authority
·         Management representative
·         Internal communication
§  Management review
·         General
·         Review input
·         Review output
6.       Resource management
·         Provision of resources
·         Human resources
¨       General
¨       Competence, awareness and training
·         Infrastructure
·         Work environment

7.        Product Realisation
·         Planning of product realization
·         Customer-related processes
¨       Determination of requirements related to the product
¨       Review of requirements related to the product
¨       Customer communication
·         Design and development
¨       Design and development planning
¨       Design and development inputs
¨       Design and development outputs
¨       Design and development review
¨       Design and development verification
¨       Design and development validation
¨       Control of design and development changes
·         Purchasing
¨       Purchasing process
¨       Purchasing information
¨       Verification of purchased product
·         Production and service provision
¨       Control of production and service provision
Ø  General requirements
Ø  Control of production and service provision-Specific requirements
§  Cleanliness of product and contamination control
§  Installation activities
§  Particular requirements for sterile medical devices
Ø  Particular requirements for sterile medical devices
§  General
§  Particular requirements for sterile medical devices
Ø  Identification and traceability
§  Identification
§  Traceability
§  Status identification
Ø  Customer property
Ø  Preservation of product
¨       Control of monitoring and measuring devices
1.       Measurement, analysis and improvement:
·         General
·         Monitoring and measurement
¨       Feedback
¨       Internal audit
¨       Monitoring and measurement of processes
¨       Monitoring and measurement of product
·         Control of nonconforming product
·         Analysis of data
·         Improvement
¨       General
¨       Corrective action
¨       Preventive action


After these provisions and requirements, Drug and Cosmetic act prescribes the annexure for medical devices.

Annexure A: The manufacturer shall prepare a succinct document in the form of Device Master File containing specific information about the device manufacturing in the premises

Annexure B: The manufacturer shall prepare a succinct document in the form of Plant Master File containing specific information about the production and/or control of device manufacturing carried out at the premises.

Annexure C: Environmental requirement for Notified medical devices and in-vitro diagnostics


For more detail refer Drug and Cosmetic Act

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