The MFDS (Ministry of Food and Drug Safety) has released and distributed the 'Medical Device GMP Evaluation Casebook,' containing actual cases of conformity assessment examinations for medical device manufacturing and quality management standards, on November 15th.
This casebook is structured to assist the industry in preparing for and responding to medical device GMP conformity assessment examinations, covering criteria for selecting items subject to evaluation, considerations for assessing contract manufacturing facilities, necessary documentation for products sterilized by end-users, and criteria for selecting manufacturing facilities for on-site inspections.
It is worth noting that this casebook compiles discussions between the MFDS and quality management inspection agencies, categorized by case and stage, from the application for evaluation to the issuance of the compliance certificate. It also consolidates frequently asked questions from the industry regarding GMP conformity assessment examinations.
The MFDS anticipates that this casebook will be helpful in reducing the preparation period and alleviating administrative burdens associated with medical device GMP evaluation within the industry.
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