In China, key regulatory policies originate with the State Council (Executive Branch). At the policy level, regulations for medical devices started in 2016 with a five-year plan. For regulatory compliance, typically there is a registration process, clinical evaluation and regulatory submission requirements.
For the high-risk, Class III (mostly implants) category, a pilot began in 2019 with the Rules for Unique Device Identification System (No. 66, 2019) with subsequent guidelines posted. The first compliance date for Batch 1, 69 product categories (including “highest risk implanted devices, including cardiac implants, brain implants and prosthesis”) were due for UDI submission as of January 1, 2021. As we look to the future, further UDI compliance activity is expected during the fourth quarter of 2021 for remaining Class III and every two years thereafter for other classes.
Below are some basics concerning registration and UDI submissions for China NMPA.
What is the UDI Application Procedure?
- Select UDI Issuing Agency (GS1 China most popular)
- Generate UDI according to the established Agency rules
- Submit UDI in Registration System (early on, included in registration process)
- Select UDI carrier and apply on the product/package
- Upload UDI to UDI Database
- Maintenance of data for changes
What to know about Data Elements
Many China NMPA data elements are common with US FDA, some are exactly the same, others are unique to China. Medical Insurance Number, Nomenclature codes, classification numbers are examples that differ. An understanding of the differences up front will help streamline the assignment of data elements.
In China, the manufacturing date is ‘always’ visible on the product label whereas in the US, no manufacturing date is required on the label. The date format is specific with exact day requirement: YYYY-MM-DD.
Note than after submission, Device Identifier (DI) and some key elements are not editable. After being published, data changes will require a request for approval to change.
What are some key compliance dates?
What is the registration framework in China for Class II and Class III devices and in-vitro devices?
- Initial registration: New product or products with major changes
- Modification: Any changes to product or related information (stricter than US FDA)
- Renewal: A product registration license is valid for five years. An extension renewal is required 6 months before the expiration date.
- Filing: Class I must adhere to the Class I catalog description
Part of the required China UDI data elements are included with the NMPA Product Certificate: Product name, device description and classification NMPA Product Certificates Number, notation (per manufacturer) concerning the UDI-DI consistency with the registered UDI-DI, applicant name, product catalog consumable/capital equipment, and Device catalog Devices or IVD.
How is the NMPA certification data related to the UDI database submission data? Are there differences between the certification and the label itself?
UDI has to be included in the initial submission (effective October 1, 2020). Then, the registrant must upload the product identification data to the China database.
UDI must be submitted in the registration system before the data is uploaded to the NMPA. Once UDI submission is approved, the label can be applied to the product and product packaging. After this process, the data can then be uploaded to the NMPA database, allowing for the certificate to be processed. In order to receive the NMPA certificate, the UDI label must be submitted during the application process.
Does NMPA require medical device registration every 5 years or do you register only the first time?
NMPA requires the original certificate to be submitted once (i.e. the first time). If there are no changes to the product [excluding mandatory ones], the original registration certificate is then used in renewals. However, if there are product changes or the original certificate is lost, a request for reissue must be submitted to obtain the new certificate.
Submitting UDI data for China NMPA may provide challenges for even the most experienced data team. For help navigating the nuances, flexible solutions and subject-matter expertise, contact Reed Tech. Email us [email protected]
Learn more about managing UDI product data for China NMPA