Medical Device Filing
Medical Device Filing
Medical device filing refers to the process where the filer submits filing materials to the National Medical Products Administration (NMPA) for Class I medical devices. The drug regulatory authority will complete the filing and issue a filing number once all required materials are submitted and meet the format requirements.
If your product belongs to Class II or Class III, please refer to Medical Device Registration.
For registered Class II and Class III medical device products, if there are substantial changes in design, raw materials, production processes, scope of application, or usage methods that may affect the safety and effectiveness of the medical device, the registrant shall apply to the original registration department for change registration procedures; for other changes, filing shall be made with the original registration department within 30 days from the date of change.
Medical Device Filing Categories
- Imported Class I Medical Device FilingSubmitted by a designated domestic legal entity to the NMPA, with proof from the filer’s home authority allowing the device to be marketed
- Imported Class I Medical Device Change FilingIf filing information changes, the filer shall submit a change filing to the original authority
- Imported Class I Medical Device Cancellation FilingIf the filer fails to cancel the filing as required, the authority may announce cancellation, after which the device may no longer be produced
Basic Requirements for Medical Device Filing
Medical device registration and filing management shall follow the principles of legality, science, openness, fairness, and justice.
Legal and Compliant
Overseas need agent
Filers need expertise
Submit Materials
Filing Materials Review and Processing
After receiving the application, the drug regulatory authority shall review the application materials and handle it according to the following situations:
- If within this agency’s authority and materials meet formal review, the application is accepted
- If materials are incomplete or not in legal form, all needed corrections must be advised within 5 days
- If not within this agency’s authority, a non-acceptance decision is issued and the applicant directed accordingly
Regulix® has extensive expertise in medical devices registration. We provide full-process technical support—from substance identification to submission—offering rapid, practical solutions to ensure smooth registration and reduce time and cost.
Regulix® integrates regulatory requirements with clients’ needs to deliver efficient, compliant registration solutions. Through analysis of registration paths, data, and timelines, we help minimize costs and shorten cycles while ensuring compliance and reducing risks of data revision.
From project initiation and testing guidance to submission and compliance maintenance, Regulix® offers comprehensive one-stop services. We act as a long-term partner, monitoring regulatory updates and supporting clients in maintaining ongoing compliance and stable product operations.