Administrative measures for registration and filing of medical devices Order of the State Administration of market supervision No47number and Administrative measures for registration and filing of in vitro diagnostic reagents Order of the State Administration of market supervision No48number Hereinafter collectively referred to as way Published on2021year10month1Effective date.For better implementation way Relevant requirements of,The relevant questions fed back by enterprises in the implementation of laws and regulations are now answered as follows

1. way After implementation,Class II medical devices Containing in vitro diagnostic reagent What are the changes in the registration and declaration information requirements

2022year1month1From the day,The application materials for registration of class II medical devices shall comply with Announcement on publishing the requirements for registration and application materials of medical devices and the format of approval documents 2021Year121number and Announcement on publishing the requirements for registration and application materials of in vitro diagnostic reagents and the format of approval supporting documents 2021Year122number Provisions of.

2.How to understand the starting date of the validity of the registration certificate

2021year10month1From the day,Starting date of validity of the registration certificate approved and issued Terms on the old certificate implement way Article 84.

3. way After implementation,Is there any change in the form of registration certificate

2022year1month1From the day,The form of registration certificate shall comply with121number 122Relevant requirements of Circular No.

4.If there are new mandatory standards for medical devices within the validity of the medical device registration certificate Or national standard,The same below Release and Implementation,Is it necessary to apply for change of registration keep on record

If new mandatory standards for medical devices are issued and implemented within the validity period of the medical device registration certificate,The changes made by the registered products to meet the new mandatory standards belong to the changes that should be registered,The registrant shall submit the application for change registration that has been approved by the original examination and approval department before continuing the registration keep on record Copies of documents and their attachments.Changes made by registered products to meet the new mandatory standards belong to those that can meet the new mandatory standards without going through change registration procedures or changes,The registrant shall provide information description and relevant supporting materials.

5.Under what circumstances will the registration certificate number change

The enterprise applies for change of registration of the original registration certificate or goes through change filing,Medical device change registration keep on record The registration certificate number published in the document is the original registration certificate number If the enterprise applies for renewal of the original registration certificate at the same time,The renewal of registration requires the issuance of a new registration certificate number,In this case,The original registration certificate number can be stated in the remarks column of the renewal registration certificate.Change registration of corresponding products and medical devices keep on record Documents regardless of approval time,Can be used together with the registration certificate of renewal registration approval.

1. way After implementation,How to carry out the verification of class III medical device registration quality management system

2022year1month1From the day,The verification of class III medical device registration quality management system continues to be carried out in accordance with the original state food and drug administration On printing and distributing the verification procedures for the registration quality management system of class III medical devices in China provisional Notice of Food and Drug Administration 2015 63number handle,After the State Administration revises and issues the new verification procedures,According to the new regulations.

2. way How to carry out registration verification for class II medical device registration business accepted before implementation

2022year1month1From the day,The acceptance number of class II medical device registration application is2021Year,The registration verification shall still submit the system verification data according to the original procedure The registration application acceptance number is2022Verification data of the independent declaration system in.

3. way After implementation,Can I make an appointment for on-site verification

2022year1month1From the day,The applicant shall be deemed to have established a quality management system when accepting the registration application materials,Ready for on-site inspection.

1.How to carry out registration self inspection

2021year10month1From the day,The self inspection of registration shall comply with the requirements of the State Food and drug administration About Publishing<Regulations on self inspection management of medical device registration>Announcement of 2021Year126number Provisions of.

way Registration application items that have been accepted before implementation but have not yet made an approval decision,If the corrected materials involve the inspection report,The registration applicant may entrust a qualified medical device inspection institution to issue a supplementary inspection report For example, the system verification of the registered applicant covers the inspection ability,You can also follow way And submit supplementary self inspection report according to relevant requirements.

To carry out registration self inspection,The applicant shall have the ability of self inspection.On submitting self inspection report,When deemed necessary by the technical review,On site inspection of self inspection capability shall be carried out.

2.If not capable of self inspection,How does the registration applicant provide the product inspection report

For projects without self inspection capability,The registration applicant shall entrust a qualified inspection institution for inspection,And the qualification of the entrusted inspection institution Inspection ability Evaluation of inspection scope,And submit the evaluation opinions on the inspection organization.Medical device inspection institutions in compliance with the original state food and Drug Administration Notice on printing and distributing the qualification recognition conditions of medical device inspection institutions Food and Drug Administration Department 2015 249number And the State Food and Drug Administration About clarity<Specification for inspection of medical devices>Notice on matters related to marking qualification identification marks External letter from comprehensive Department of Drug Administration 2020 746number On the basis of regulations,The inspection report issued by it can be recognized as registration application materials.Applicants can visit CNCA's website http://www.cnca.gov.cn/ internet+service-Inspection and detection-National qualification certification institution Query whether the inspection organization has the corresponding inspection capability.

3.If the inspection institutions do not have the corresponding inspection qualification of the applicant's products,How does the registration applicant provide the product inspection report

2022year1month1From the day,The inspection institutions do not have the corresponding inspection qualification of the applicant's products,The applicant in this province can entrust the provincial medical device inspection institute for inspection.

1. way After implementation,How to carry out the implementation of medical device registrant system

2022year1month1From the day,The implementation of medical device registrant system shall refer to the original relevant regulations and work requirements of our province.The verification of the class III medical device registration quality management system of the medical device registrant shall be organized and carried out in accordance with the relevant work requirements of the State Food and Drug Administration and the national device evaluation center.The State Administration of Market Supervision issued and implemented the new version Measures for the supervision and administration of medical device production after,In accordance with the relevant regulations and documents of the State Food and drug administration, the implementation policies of the provincial class II medical device registrant system shall be separately studied and formulated.