In this article we will provide a general introduction about Clinical Evaluation Report (CER) for medical devices registration and application in China. Current regulations in both China and EU require CER for medical device registration. In this article, we will cover the CER document requirements by China’s NMPA (CFDA) as well as differences between EU and China in CER requirements.
The following is the list of NMPA regulations governing medical device CER requirements in China:
|Decree 680 – Regulation on Supervision and Administration of Medical Devices|
|Decree 4 – Provisions for Medical Device Registration|
|Technical Guidance on Clinical Evaluation of Medical Devices|
|Announcement for Medical Device Registration Dossier Requirements and Certificate Template|
Contact us at firstname.lastname@example.org for a copy or more information.
To begin with, as the name indicates, a Clinical Evaluation Report (CER) is a file that you prepare in order to document data and results of the clinical evaluation of your medical device. In China, all medical devices are divided into three classes by their risk levels:
|Class I||Class II||Class III|
|Low-risk medical devices whose safety and effectiveness are ensured through routine administration.||Mid-risk medical devices that require further control in order to ensure their safety and effectiveness.||High-risk medical devices that are implanted into the human body, used to support or sustain life, or pose potential risk to the human body and thus must be strictly controlled in respect to safety and effectiveness|
Clinical Evaluation Reports are required for all medical devices in Europe. In contrast, CERs are not required for Class I medical devices in China.
However, in China there are two types of CERs:
In the following, we will cover the differences between these CER types.
The CER of this type and supporting documents should provide demonstrated equivalence between the device in application and an existing device already approved and listed in the NMPA Catalog.
In summary, the clinical-exempt CER should include following:
Specifically, China’s NMPA (CFDA) expects you to provide the following comparisons in the CER for your clinical-exempt device:
|Manufacturing materials or manufacturing materials in contact with human body|
|Method of application|
Note: The comparison items can be added according to actual needs.
You will prepare this type of CER through evaluation and analysis of clinical data of Equivalent Medical Device.
For clinical non-exempt devices, CER reports should include following:
1. Predicate product determination
When choosing an equivalent device for your China CER, the first requirement is that it must has been approved by NMPA (CFDA) in China. Additionally, the equivalent device must be within its validity period (all devices in China must be renewed every 5 years in order not to lose their validity). Equivalency between the chosen predicate and your product must be clearly demonstrated in all of these areas:
|1. Product’s basic principle||6. Safety evaluation|
|2. Structure||7. Alignment with national/industry standards|
|3. Manufacturing materials||8. Intended use|
|4. Production processes||9. Other aspects of basic equivalency|
|5. Performance requirements|
Note the NMPA may accept the differences between the predicate and your product, if there is no effect in safety & effectiveness.
A manufacturer may not have its own predicate device approved by NMPA (CFDA) to show equivalency. In this case, the manufacturer must obtain authorization from a third-party manufacturer with a similar device.
2. Evaluation path
3. Comparison of device in application and the equivalent device.
You must provide NMPA with equivalence comparisons in all of the following areas:
|1. Basic principles||9. Using methods|
|2. Components||10. Contraindications|
|3. Production technology||11. Precautions & warnings|
|4. Manufacturing materials||12. Delivery condition (passive device)|
|5. Specification||13 Sterilization & Disinfection methods|
|6. Safety evaluation||14. Packaging|
|7. National/industrial standards||15. Label|
|8. Intended use||16. Instruction for Use|
In your CER for the NMPA (CFDA), you will also need to show that if the differences between the product in application and its predicate affect safety and effectiveness.
Data for safety and effectiveness analysis in your CER may include:
4. Analysis of clinical data of predicates.
Current regulations in both China and EU require CER for medical device registration. As an IMDRF member and president for the current cycle (starting in 2018), China is taking effort to be more harmonized with international standards. However, CER in China is still very different from EU CER.
Key differences between China and EU CERs include:
|China CER||EU CER|
| Purposes: |
Justify why differences between device in evaluation and predicate do not negatively impact safety and performance.
| Purposes: |
Meet essential requirements/GSPR.
|Premarket submission only.||Lifecycle process; must be iterated.|
|Require CER update in a design change submission.|| Additional content: |
State of the Art (SOTA) CEP/scoping, Postmarket surveillance plan/postmarket clinical follow-up (PMCF).
Check here for more information about NMPA (CFDA)’s medical device and IVD regulations. Contact China Med Device at email@example.com for more information about CER in China and EU for your medical device.
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we represent manufacturers for the complete product life cycle without their need to create a local entity in China. Specifically, our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.