Understanding the China regulatory system for medical devices
Because of their potential impact on public health, countries require regulatory control of all medical devices. In most cases, manufacturers are requested to register their medical devices and comply with local regulatory requirements prior to being allowed to ship and sell their products in other countries. In China, the regulatory agency that handles all medical device registration applications is The State Food and Drug Administration (SFDA).
Applicants often have difficulty preparing the required documents and successfully working with the complicated registration process. Now UL provides advice and services to support medical device manufacturers with their SFDA registration application. UL has extensive experience in managing global projects and can use this experience to support manufacturers with registration support for multiple markets concurrently.
Regulation Overview
Governing Authorities
The State Food and Drug Administration (SFDA): It is responsible for supervision and administration of medical devices in China. It is the governmental authority that issues Medical Device Registration Certificate for foreign manufacturers.
The State General Administration of Quality and Supervision (AQSIQ): It operates the Chinese Certification program for eight categories of medical devices requiring certification under China Compulsory Certification (CCC Mark).
Device Classification
The criteria for medical device classification is based on its structural characteristics, form of operation and conditions of use.
- Class I Medical Devices refer to those products under routine administration for their safety and efficacy and include such products as rehabilitation techniques, disinfecting devices and apparatus
- Class II Medical Devices include those that must be controlled for their safety and efficacy, such as weak laser in-vitro treatment instruments and blood assay devices
- Class III Medical Devices are those implanted into the human body, or used for life support or sustenance, and pose potential risk to human life, such as implanted artificial internal organs and infant care devices
Agents and Local Representatives
- Registration Agent: To coordinate and control SFDA registration
- Legal Agent: Report any adverse events regarding the medical device that occurs inside or outside China to SFDA. Handle any recall incidences in China if they arise
- After Sales Agent: Provide technical service and maintenance support, which must be included in the business scope of the business license
Medical Device Validation Testing
Manufacturers must write standards and file for validation testing at SFDA designated sites for the to-be-registered products. There are product categories that also require China Compulsory Certificate (CCC Mark).
Clinical Evaluation/ Investigation
In China, clinical investigations are required for Class II and Class III medical devices. Except for new implant products and in-vitro reagents, foreign clinical data are mostly accepted and local investigation could be exempted in most circumstances.
Quality System Requirements
The manufacturing site of the imported products must demonstrate compliance to ISO 13485, US FDA QSR or equivalent certification from the country of origin.
Application Fee
No application fee is required.
What is the process?
- Identify Application, Legal & After-Sales Agent
- Determine Device Classification
- Formulate the test standard and file for tesitng approval
- Determine Clinical Evaluation Path and conduct Clinical Study if required.
- Prepare the Chinese documents and submit to the SFDA.
What documents do I need to prepare to apply?
- Legal registration requirements
- Certificate of quality management system (your UL ISO 13485 certificate is acceptable)
- Marketing approval certificate
- Authorization letters to registration agent in China
- Quality guarantee letter
- Truthful and accuracy self-guarantee letter
- Other documents as requested
Note: Some of these documents must be notarized copies.
Advantages to UL's SFDA application services
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- Up to 33% quicker than other application service providers, so your product can get to market quicker and you can start selling your device in China sooner.
- Over 200 completed SFDA applications so we can guide you through the process and anticipate revisions prior to waiting in the SFDA line.
- With locations around the world, we can communicate with you in your local language and time zone while our experts in China guide your product through the registration process
- We provide more complete services than a regulatory agent
- UL has a history of over 115 years as a well-known certification body and 3rd party reviewer. Because of this experience, UL has become highly knowledgeable on regulatory requirements
- Our experienced team includes members who have previously worked with regulatory agencies
For more detailed information regarding the process and UL services, contact UL at Medical.Inquiry@UL.com
