In order to standardize the medical device registration certificate information, reduce the error rate of the information shown on the registration certificate and its attachments, improve the quality and efficiency of technical review, the Center for Medical Device Evaluation (CMDE) has added one more step to confirm the information shown on the medical device registration certificate and its attachment in the process of technical review from June 7, 2021.
1. The scope of application
Initial product registration, change of approved items, registration renewal for domestic Class III, import Class II and Class III medical device.
2. Content of confirmation
a) Contents stated in the registration certificate;
b) Contents stated in the approval letter of amendment;
c) The attachments of the registration certificate or approval letter of the amendment, including product technical requirements, product specifications, the information of registration certificates, or amendment in the form of attached pages.
3. Confirmation routes
a) For online application items, confirmation is done in the eRPS system
b) For offline application items, confirmation by email
c) Applicants/registrants/agents can log in to the eRPS system (online items) or receive confirmation forms via e-mail (offline items) to view the items to be confirmed and verify item by item. After verifying the information is correct n, check "consent" after the column of verified items. If the information is incorrect, check "disagree" after the column of verified items, and fill in the column of "revised information" with the correct information. Once all column information has been verified and confirmed, for online confirmation, it should click on the "Complete confirmation" button and for the offline confirmation, it should be replied to the reviewer by e-mail.
4. The applicant or /agent shall reply within 2 working days (excluding the day of receipt) from the date upon receiving the confirmation form, and if he or she does not reply to the comments, the applicant/ or agent shall deem to agree with the information shown on the registration certificate or approval letter of change and its attachments.
5. Upon confirmation of all the information, the applicant or agent shall send the final version of documents in the PDF format including product technical requirements, product specification, the attachments of the registration certificate, or approval letter of change to the reviewer's email.
Notice on the confirmation of medical device registration certificates and their attachment information (No. 9 of 2021)