MDSAP is a certification system created by five regular member countries, the United States, Japan, Canada, Australia, and Brazil, for the purpose of joint review according to international standards for medical device safety and quality control.
From December 19, 2023, the Ministry of Food and Drug Safety revised part of the Medical Device Manufacturing and Quality Control Standards to improve the screening method by expanding the scope of use of MDSAP review results and improving duplicate submission documents.
The major revisions are as follows.
1) Article 6 (Review method for conformity recognition, etc.)
Even if you have an MDSAP certificate of conformity, an on-site investigation must be conducted in the following cases.
a. Manufacturers subject to regular inspection under Article 4 (2)
b. A manufacturing facility recognized by the Minister of Food and Drug Safety that the results of the examination, such as recognition of suitability under MDSAP, may affect public health, such as the discovery of significant nonconformities
c. Convergence Medical Device Manufacturing Station
d. Medical device manufacturing facility containing human-derived ingredients or using human-derived tissue
2) Article 7 (Review application for conformity recognition, etc.)
Manufacturers that have received a certificate of conformity using MDSAP are excluded from the batch application for regular inspection.
3) Article 9 (Validity period of conformity certificate)
If a conformity recognition audit is conducted using MDSAP, the manufacturer shall be calculated in the same manner as the validity period of the MDSAP conformity recognition certificate.
4) Table 2
Review details (MDSAP utilization) Form 1 newly established
5) Table 5
Quality control review agency TUV SUD Korea added
Please refer to the file below for details.
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