With the aim of strengthening the classified management of medical devices, and in accordance with the "Regulations on the Supervision and Administration of Medical Devices", the "Measures for the Registration and Filing of Medical Devices", the "Measures for the Registration and Filing of In Vitro Diagnostic Reagents", and other relevant requirements, this Announcement further clarifies the work related to registration and filing following the adjustment of the management categories and classification of medical devices (including in vitro diagnostic reagents, hereinafter referred to as "medical devices"). The relevant matters are hereby announced as follows:
I. Requirements for Registration and Filing Following Adjustment of Medical Device Management Category
(1) Regarding the Validity Period of the Original Medical Device Registration Certificate. If the document adjusting the management category contains specific provisions on the validity period of the original medical device registration certificate, such provisions shall be followed. If no specific provisions exist, this Announcement shall be followed.
(2) Regarding Initial Registration. From the effective date of the management category adjustment, for medical devices for which an initial registration application is submitted, the registration application shall be accepted according to the adjusted category.
For initial registration applications that were accepted before the effective date of the management category adjustment but for which an approval decision has not yet been made, the competent regulatory authority continues the review and approval process according to the original management category. Upon approval, the adjusted management category shall be specified in the remarks column of the registration certificate. For adjustments that include a registration transition period, the validity period of the medical device registration certificate shall not exceed the end date of the said transition period.
After the registrant obtains the medical device registration certificate under the adjusted management category, they shall proactively apply for the cancellation of the original medical device registration certificate. If they fail to do so proactively, the original registration authority shall carry out the cancellation procedure.
(3) Regarding Renewal Registration. For renewal registration applications that were accepted before the effective date of the management category adjustment but for which an approval decision has not yet been made, the competent regulatory authority continues the review and approval process according to the original management category. If the renewal registration is approved, the adjusted management category shall be indicated in the remarks column of the registration certificate. For adjustments that include a registration transition period, the validity period of the medical device registration certificate shall not exceed the end date of the said transition period as stipulated in the relevant document.
For medical device registration certificates approved before the effective date of the management category adjustment, if the product management category is adjusted from a higher risk classification to a lower risk classification, and renewal is required upon expiry of the validity period, the registrant shall apply for renewal registration or complete filing with the corresponding competent regulatory authority according to the adjusted category. The competent regulatory authority, upon approving the renewal registration, shall issue a new medical device registration certificate in accordance with the relevant medical device classification and the management category, and shall indicate the original medical device registration certificate number in the remarks column. For those that submit filing dossiers that meet the requirements of the "Regulations on the Supervision and Administration of Medical Devices" and other relevant rules, the filing shall be completed, and the original medical device registration certificate number shall be indicated in the remarks column of the filing information form.
For medical device registration certificates approved before the effective date of the management category adjustment, if the product management category is adjusted from a lower risk classification to a higher risk classification, the registrant shall apply for registration with the competent regulatory authority according to the adjusted management category. For medical device registration certificates approved before the effective date of the management category adjustment, the original medical device registration certificate shall not exceed the end date of the registration transition period stipulated in the management category adjustment document. For products that, with technological development, are clearly determined to be Class III medical devices, the Class II medical device registration certificates approved before the effective date of the management category adjustment remain valid within their validity period. If, within the validity period of the original medical device registration certificate, a registration application is filed according to the higher adjusted risk classification, and if the original registration certificate expires before the end date of the transition period (if any), the registrant may apply for renewal registration with the original competent authority according to the original management category, provided that the product is safe and effective and no serious adverse events or quality accidents have occurred after market launch. If the original competent authority, upon review, finds the conditions met and approves the renewal registration, it shall indicate the adjusted management category in the remarks column and shall limit the validity period of the medical device registration certificate so that it does not exceed the end date of the management adjustment transition period. After the registrant obtains the medical device registration certificate under adjusted management category, they shall proactively apply for the cancellation of the original medical device registration certificate. If they fail to do so proactively, the original registration authority shall carry out the cancellation procedure.
(4) Regarding Change Registration or Filing for Already Registered Products. For products that obtained a medical device registration certificate before the effective date of the management category adjustment, and for products that obtained a renewal registration according to the original category as per Article I(3) of this Announcement, if change registration or filing is required, the registrant shall apply for change registration or complete filing with the original registration authority. The competent regulatory authority, upon approving the change registration or filing, shall issue a medical device change registration or change filing document and shall specify the adjusted product management category in the remarks column.
(5) Regarding Adjustment Between Product Filing and Registration. For products whose management category is adjusted from a higher risk classification to Class I medical devices, from the effective date of the management category adjustment, filing as a Class I medical device may be completed according to the adjusted category. For those applications for initial registration that were accepted before the effective date of the management category adjustment but for which an approval decision has not yet been made, the applicant may either obtain the medical device registration certificate according to Article I(2) of this Announcement or apply for termination of the review, with the relevant registration application dossiers kept for reference.
For products whose management category is adjusted from Class I medical devices to a higher risk classification, if Class I medical device filing was completed before the effective date of the management category adjustment, the filer shall apply for registration with the competent regulatory authority under the adjusted category and shall proactively cancel the original Class I medical device filing. If, from the end date of the registration transition period (if any) stipulated in the management category adjustment document, the filing has not been proactively cancelled, the original filing authority shall announce the cancellation of the filing.
(6) Regarding Change of Product Filing. For Class I medical device filings completed before the effective date of the management category adjustment, if, before the end date of the registration transition period (if any), the information contained in the filing information form or the product technical requirements filed change and require a change filing, the filer shall apply for a change filing with the original filing authority and submit a description of the changes and the management category adjustment document. The competent regulatory authority shall record the changes in the filing information.
(7) Regarding Production, Distribution, and Import. From the end date of the registration/filing transition period (if any) stipulated in the management category adjustment document, those who have not legally obtained a medical device registration certificate or completed Class I medical device filing under adjusted management category shall not manufacture, import, or distribute the products.
II. Requirements for Products Adjusted from Not Being Managed as Medical Devices to Being Managed as Medical Devices
For products that were originally not managed as medical devices but are adjusted to be managed as medical devices, the applicant or filer shall apply for medical device product registration or complete Class I medical device filing with the competent regulatory authority. From the end date of the registration/filing transition period (if any), those who have not legally obtained a medical device registration certificate or completed Class I medical device filing shall not manufacture, import, or distribute the products.
III. Requirements for Products Adjusted to Not Being Managed as Medical Devices
For products that are adjusted from being managed as medical devices to not being managed as medical devices, from the effective date of the management category adjustment, the products shall no longer be regulated as medical devices. The competent regulatory authority shall no longer process medical device product filings or accept medical device registration applications for such products.
For applications that were accepted before the effective date of the management category adjustment but for which the registration approval process has not yet been completed, the competent regulatory authority shall terminate the review, and the relevant registration application dossiers shall be kept for reference.
IV. Others
(1) If the document adjusting the management category or classification contains specific provisions on product registration/filing, such provisions shall be followed.
(2) For products with a registration/filing transition period, registrants, filers, and relevant enterprises shall actively carry out the work related to registration/filing during the transition period, effectively fulfill their primary responsibility for product quality and safety, comprehensively strengthen quality management throughout the entire product lifecycle, and ensure the products are safe and effective.
(3) For products within their administrative region whose management category or classification has been adjusted, provincial regulatory authorities shall establish product management ledgers, consolidate the primary responsibility of enterprises, strengthen supervision and guidance, and supervise and guide registrants, filers, and relevant enterprises to carry out their work in accordance with this Announcement and the relevant documents on the adjustment of management categories or attributes.
(4) This Announcement shall take effect from the date of its issuance.
As one of the world's most stringent medical device regulatory systems, China NMPA requires careful planning when product classifications are adjusted. With 26+ years of regulatory experience and Chinese experts in our Beijing office, Qualtech supports medical device companies in managing classification changes, product registration and maintaining regulatory compliance throughout the product lifecycle. Contact us now to know more!