CHINA WARNS MANUFACTURERS ABOUT RISK ASSESSMENT REPORT DEADLINE
ISSUANCE OF NEW GUIDANCE
On August 13th, 2018, the China State Administration for Market Regulation and National Health Commission of China jointly issued the “Regulation on the Surveillance and Re-evaluation of Medical Device Adverse Events,” which officially went into effect on January 1, 2019.
To date, many companies have yet to submit the annual risk assessment reports for 2019 or 2020. Therefore, on May 6, 2020, the NMPA issued “Announcement on the Implementation of Periodic Risk Assessment Report of Medical Device Adverse Events” (Attached) and reminded medical device manufacturers that they are required to submit periodic risk assessment reports before September 30, 2020. While manufacturers of high risk products sold in Europe are required to provide ongoing updates to their Clinical Evaluation Reports, this new annual requirement is a first for competent authorities.
WHO NEEDS TO SUBMIT REPORTS?
Since 2019 was the first year of implementation, all Class II and III Devices with an active Medical Device Registration Certificate (MDRC) for any portion of 2019 will need to submit reports for 2019 and 2020 by September 30, 2020. Moving forward, and for new registrations, Risk Assessment Reports should be submitted annually in alignment with the month and day of registration issuance. When it comes to Class I devices, manufacturers do not need to submit reports and are only expected to keep the Risk Assessment Reports in their records, subject to NMPA spot inspection. It’s also important to note that Risk Assessment reports are only required for the first 5 years the product is on the market, moving forward and must be submitted in Mandarin.
RISK ASSESSMENT REPORTS
Manufacturers of Class II and III products will now need to maintain and submit annual reports showing the NMPA that they are effectively monitoring and resolving any issues with their products on the Chinese market, and around the world, while also showing that they are continuously reviewing literature, assessing potential risks and maintaining proactive safety and efficacy controls. Report components include general product information, analysis of production and circulation processes, complaint analysis, expert discussions (if needed), risk controls, etc.
Note: Risk Assessment Reports can cover multiple medical devices if they are used together but have different registrations such as single-use sterile syringes or hip systems.
Currently, the Reports should be submitted by the Manufacturers’ China Agent via the NMPA’s e-Portal but is expected to eventually allow manufacturers to submit their own Reports. Asia Actual works with highly experienced professionals in China that can provide you with accurate and timely Risk Assessment reports for your products that will not only satisfy the NMPA’s requirements but could also be used for updating Clinical Evaluation Reports in other markets. Please reach out if you need assistance, and if your distributor currently holds your registration, contact us to learn more about how we could provide you a compliant report for them to submit.