Medical device enterprise registration consulting service provider - HongMaoKang

A: According to Article 16 of Regulations on the Administration of Instruction and Label of Medical Devices, when an approved medical device is changed, the applicant should amend the instruction and label on his own according to the approved change document. If the changed contents of instruction is not specified in the registration certificate and its attachments, which is not within the scope of change registration, it should be notified in writing to the approval department for medical device registration, and submit relevant documents including comparison statement on the change of the instruction.

A: For most medical devices (non-in vitro diagnostic reagents), the stability and validity period of various properties of the product usually depend on the raw materials used in the product and the aging mechanism of the materials, such as thermal aging, photo aging, etc. As long as the raw material properties, production process and packaging materials of the product remain stable, in principle, the differences between batches should not affect the performance stability and validity period of the product. Therefore, in general, batches do not need to be considered when conducting performance studies. If the product has special characteristics, such as containing biologically active substances, the impact of batch-to-batch variation on product performance can be considered.

A: It should be analyzed whether the changes of the product technical specifications and other contents described in the Registration Certificate are involved. If so, a change of registration should be applied. If not, a change of registration should not be required and only relevant work should be done according to the requirements of the enterprise’s quality management system (OMS).

A: If the medical device registration certificate needs to be renewed after the expiration of the validity period, the registrant should apply for the renewal of registration 6 months before the expiration of the medical device registration certificate, and follow the submit application materials as required. If the application materials are incomplete or do not conform to the statutory form and need to be supplemented and corrected, our center will indicate the time of the registrant’s first application for renewal of registration in the notification of acceptance of corrections. When the registrant applies for renewal of registration again after making corrections, he should submit the notice of acceptance of supplements and corrections. The Center For medical Device Evaluation. NMPA will determine whether the application for renewal of registration is within 6 months after the expiration of the validity period of the medical device registration certificate according to the time of the registrant’s first application for renewal of registration indicated in the notice of acceptance of supplements and corrections, and review the application materials in accordance with the provisions of the Administrative Measures for Registration and Filing of Medical Devices.

A: In this case, the original registered product can be selected as the predicate device for clinical evaluation. Attention should be mainly paid to whether there is any difference between the proposed product and the original registered product in comparison with the predicate device. If there is no difference between the two products, the clinical data to be provided may include the pre-marketing and post-marketing clinical data of the product, and the clinical experience data including post-marketing adverse events.