Key Points Worth Noting under the New Registration and Filing Regulations for Medical Devices and IVD

The Provisions for Medical Device Registration and Filing and the Provisions for In-vitro Diagnostic Reagent Registration and Filing have been issued and shall come into force as of October 1, 2021. For better implementation of the provisions, relevant matters are announced as follows:

I. Handling of the registration applications that have been accepted before the implementation of the provisions

For the registration applications that have been accepted before the implementation of the Provisions but for which the review and approval decision has not been made, NMPA shall continue the review and approval in accordance with the original provisions, and issue the medical device registration certificate to those meeting the marketing conditions.

Where the approval time for registration renewal is within the validity period of the original registration certificate, the starting date of the validity period of the registration certificate for registration renewal shall be the next day of the expiry date of the original registration certificate;

where the approval time is not within the validity period of the original registration certificate, the starting date of the validity period of the registration certificate for registration renewal shall be the date of approval of registration renewal.

II. Type testing report related to supplementary dossiers

For the registration application items that have been accepted before the implementation of the Provisions but have not yet been approved, if the supplementary dossiers needed involve the type testing report, the registration applicant shall entrust a qualified medical device testing institution to issue the supplementary test report; if the system verification by the registration applicant covers the testing ability, the supplementary self-test report may also be submitted in accordance with the Provisions and relevant requirements.

III. Examination of the registration application items accepted prior to the implementation date of the new mandatory standards

For the medical device under application for registration, in case of any change to the mandatory standards cited in the product technical requirements, unless otherwise specified by NMPA in the documents of standards for implementation, where the registration is accepted prior to the implementation date of the new standards, review and approval may be conducted in accordance with the original standards. From the date when the new standard is implemented, enterprises shall fully implement the new standard, and the products shall meet the requirements of the new standard.

IV. Biological test of medical devices

Where biological test is involved in the biological evaluation of a medical device, the applicant shall submit the biological test report as research data when applying for registration. For biological test, a medical device testing institution with biological test qualification shall be entrusted to conduct the test in accordance with relevant standards. The biological test report issued by a foreign laboratory shall be accompanied by the quality assurance documents issued by the foreign laboratory indicating that it meets the requirements of GLP.

V. Registration (filing) form for imported medical devices and medical devices manufactured in China

For imported medical devices, the overseas registration applicant (filing entity) shall apply for registration (conduct filing); for the medical devices manufactured within the territory of China by overseas enterprises, the domestic manufacturing enterprise shall apply for registration (conduct filing) as the registration applicant (filing entity).

VI. Filing of Class I Medical Devices

It is not required to submit clinical evaluation materials for filing of Class I medical devices.

VII. Documents related to the administration of medical device registration

(1) After the implementation of the Measures, the relevant documents on the registration management of medical devices in the Annex shall be abolished simultaneously.

(2) For the matters involved in the Measures, if it is clearly specified in the documents on the registration management of medical devices previously issued by the drug regulatory authority under the State Council, the original provisions shall still be implemented.

Once the new regulations are issued, all related registration applicants shall obey them. Therefore, special attention should be paid to whether their products meet the above principles when applying for registration. Brady has seasoned staff in registration and can help manufacturers on legal compliance. If you have any questions, please feel free to contact us (info@inspirativemed.com) for more information.