On Aug. 26, China State Administration for Market Regulation released Administrative Measures for Medical Device Registration and Filing1 (hereafter referred to as Measures), set to take effect on Oct. 1, 2021.
The Measures was formulated pursuant to the Regulations for the Supervision and Administration of Medical Devices2, which came into force on June 1, 2021.
The content of this article is as follows:
Application scope of the Measures;
Medical device classification in China;
Introduction to medical device registration;
Introduction to medical device filing;
Qualification of registration/filing applicant/agent;
Competent authority to submit application/file documentation to;
Registration application/filing documentation;
Conditions for clinical evaluation exemption;
Special approval for medical devices;
Product change and validity extension;
Adjustment to the class of a registered medical device.
RELATED:
1. Application Scope of the Measures
The registration, filing, supervision and administration of medical devices in China.
2. Medical Device Classification in China
China classifies medical devices according to their risk levels:
Class I:
with low risks;
the device's safety and efficacy can be guaranteed under routine management.
Class II:
with moderate risks;
subject to strict control and regulation to ensure the device's safety and efficacy;
Class III:
with high risks;
subject to strict control and regulation with special measures to ensure the device's safety and efficacy.
3. Medical Device Registration
Definition:
Medical device registration refers to that the applicant applies for medical device registration in accordance with legal procedures to a medical products administration. The administration reviews the safety, effectiveness and quality controllability, then decides whether to approve the application.
Application scope:
Class 2 and Class 3 medical devices.
4. Medical Device Filing
Definition:
Medical device filing refers to that the applicant submits the documentation of a medical device to a medical products administration. The administration puts the documents on file for future reference.
Application scope:
Class 1 medical device.
5. Qualification of Registration/Filing Applicant/Agent
A medical device registration/filing applicant shall be a company or research institute that is capable of shouldering legal responsibilities. An overseas registration/filing applicant shall appoint a corporate legal entity in China to act as an agent for carrying out registration/filing affairs.
6. Competent Authority to Submit Application/Documentation to
Medical Device Registration/Filing in China | ||
Class | Submission to Authority | |
Domestic | Class 1 | File documentation to the municipal medical products administration of a city with subordinate districts. |
Class 2 | Submit the application to the medical products administration of a province/autonomous region/municipality directly under the Central Government; Medical Device Registration Certificate will be issued after approval. | |
Class 3 | Submit the application to the National Medical Products Administration (NMPA); Medical Device Registration Certificate will be issued after approval. | |
Imported | Class 1 | File documentation to NMPA. |
Class 2 | Submit application to NMPA; Medical Device Registration Certificate will be issued after approval. | |
Class 3 | ||
7. Registration Application/Filing Documentation
The submitted documents, whether for registration or filing, shall include:
Product risk analysis;
Technical requirements of the product;
Product test report;
Clinical evaluation (can be exempted in certain situations);
Sample manuscripts of the product instructions and labels.
Documents that are relevant to the quality management system (QMS) of product development and manufacturing.
Other necessary documents to prove the safety and efficacy of the product.
The above is a brief summary of the documents need in submission. The following is a more detailed explanation of the three required documents that applicants should pay attention to.
Non-clinical evidence
The registration application/filing documentation shall include non-clinical evidence during the development stage. For example, summary of the non-clinical research report, research plan and research report.
Test report
A test shall be completed, and the test report shall be submitted before registration/filing. Only with a qualified test result can a clinical trial be conducted or the registration/filing process begins.
Marketing authorization certificate outside of China (only for imported medical devices)
Both registration and filing of imported medical devices into China shall comply with the submission rules listed below.
Marketing Status | Document to Submit |
Sold as a medical device in the country/region of the registration applicant/filing applicant/manufacturer | Marketing authorization certificate issued by the authority of the corresponding country/region |
Not sold as a medical device but still sold in the country/region of the registration applicant/filing applicant/manufacturer | Documentary evidence showing that the authority of the corresponding country/region has granted marketing authorization to the medical device |
Not sold in the country/region of the registration applicant | No documents relevant to marketing authorization shall be submitted |
Notes: the registration application/filing documentation shall be in Chinese. If the documents are initially in a foreign language, a Chinese translation shall be submitted together.
8. Conditions for Clinical Evaluation Exemption
Registration/filing applicants can skip clinical evaluation only when the medical device meets one of the following conditions:
The medical device has a clear work mechanism and a fixed design, and is produced with mature technologies. There is a same type of previously approved product that has been clinically used for years with no record of severe adverse events. Also, the new medical device's functions are kept the same as the normal ones of this type of medical devices.
There are other methods to prove that the new medical device is safe and effective.
For medical devices meeting the condition, clinical evaluation documents are not required in the submission. The existing List of Medical Devices Exempted from Clinical Trials3 released in Jan. 2021 is still in effect before the List of the Medical Devices Exempted from Clinical Evaluation is formulated, adjusted and released by NMPA.
9. Special Approval for Medical Devices
There are three programs for special approval for medical devices:
(1) Innovative Product Registration for medical devices meeting all the following three requirements:
① - The applicant has a registered patent for innovative technology,
- or the applicant got the authorization to use the technology in China within the past five years;
- or the applicant's innovative technology patent application has been made public by the patent department of the State Council, and it has a retrieval report by China National Intellectual Property Administration (CNIPA) proving the technology is innovative and creative.
② The applicant has completed early-stage research and decided on the fixed pattern of the product, with authentic and traceable research data;
③ The product has a trailblazing work/function mechanism in China. It has essential advantage over the same type of products in the aspects of functions and safety. It is embedded with world-leading technology and distinct clinical value.
(2) Priority Registration for medical devices meeting all the following three requirements:
① - For the diagnosis or treatment of rare diseases or malignant tumors and with distinct clinical advantage;
- or for the diagnosis or treatment of diseases special to and prevalent in people of old ages, and without effective diagnosis or treatment methods;
- or exclusively used in children and with distinct clinical advantage;
- or urgently needed in China's clinical settings, and no same type of medical device has been approved.
② Listed in China's national science and technology major project or major research & development plan;
③ Other medical devices considered to be qualified by NMPA.
(3) Emergency Registration for medical devices meeting one of the following two requirements:
① Urgently needed in public health events and there is no same type of products approved in China;
② There are other products of the same type that have acquired marketing authorization, but the supply is insufficient to tackle the public health event.
10. Product Change and Validity Extension
Registered Class 2 and Class 3 medical devices:
If the registrant plans to make changes to the design, raw materials, manufacturing techniques, application scope and methods of usage and thus bring potential change to the product's safety and efficacy, it shall submit a change application to the authority which previously issued the registration certificate.
For other changes, the registrant shall file a document stating the change to the authority where the registration certificate was from.
On-file Class 1 medical devices:
If the filing person wants to make changes to the product’s technical requirements recorded in the on-file information form, the person shall file a change statement and relevant documents to the authority which previously put the product on file.
11. Adjustment to the Class of a Registered Medical Device
Registrants shall take corresponding measures if NMPA adjusts the class of registered medical devices.
Adjustment to the Class of a Registered Medical Device in China
For more details of medical device registration and filing in China, welcome to contact us via email to contact@chemlinked.com.
