CFDA issues Guideline of Standard Drafting for Annual Self-Review Report of Quality Management System for Medical Device Manufacturer (Exposure Draft)

In order to strengthen the quality management for medical device manufacturer, and standardize the self- review of quality management system, CFDA drafts the Standard Drafting for Annual Self-Review Report of Quality Management System for Medical Device Manufacturer (Exposure Draft) according to The Regulation of Supervision and Administration of Medical Device, and issued to seek for public feedbacks on Mar 3^rd, 2016.
The annual self-review report shall include as following based on the Exposure Draft:

1. Summary

1.1 Basic information of producing activity

1.2 Annual material alterations

1. Change of organizational structure of quality management system, which include key persons change, such as person in charge of enterprise, management representative, etc.
2. Change of production technology process and equipment; if the key process or special process has been changed, you shall detail the situation of process validation and equipment validation.
3. Supplier change; for the key material supplied by external provider, you shall detail the relevant condition and control measure if the key material supplier make change.

1.3 Implementation of management commitment

2. Operational condition of quality management system

2.1 Personnel training and management: shall include the training record and evaluation of the relevant personnel, as well as description of effectiveness evaluation of training.

2.2 Production management and quality control: shall include the equipment obsolescence, update, maintaining and calibration; verification of production equipment and production condition; filing condition of record related to production and inspection; sub-contract production condition and management.

2.3 Design and manufacturing technique change: if the design which related to product safety, performance and intended use has been changed, you shall detail the description of design change, review, verification and validation, as well as the changed product whether meet the requirements of relevant regulations.

2.4 Purchase, sale and after-sale service: shall include supplier review and evaluation, development condition of sale and after-sale service, and so on.

2.5 Non-conforming product control: shall include correction actions in response to nonconforming product detected during product selective acceptance and productive process, and before delivery, as well as quality accident.

2.6 Internal review and management evaluation:

1. Annual internal review, which include implementary frequency, audit department, subject materials and correction measure.
2. Annual management evaluation, which include implementary frequency, evaluation result, subject materials and correction measure.

2.7 Adverse event monitoring: shall include the development situation of adverse event monitoring and re-evaluation, as well as disposition of serious adverse event.

3. Other items

3.1 Implementation condition of medical device regulation and mandatory standards;

3.2 Annual administration or certification review situation;

3.3 Subject matter found by annual self-review and correction measure.