Here’s April’s NMPA news affecting MedTech pros who offer devices and IVDs in China, provided by China Med Device, LLC. Forward this newsletter to a colleague and opt-in here. For additional tools to secure China success, see our Resources section below.
Policies
National Standard for Medical Electrical Equipment Released
China mandated electrical medical device manufacturers to comply with its national mandatory standard GB 9706.1-2007, equivalent to IEC 60601-1 Edition 2, since 2008. Even though overseas manufacturers adopted IEC 60601-1 Edition 3.1 in 2012, China remained at IEC 60601-1 Edition 2. The result of such a long-time delay in adopting the latest standard is increased cost and time delays for manufacturers.
However, the burden will be eased as the updated national standard of GB 9706.1:2020, equivalent to IEC 60601-1 Edition 3.1, was published on April 9. For our comprehensive review please click HERE
Sterile and Implantable Devices Under Inspection
High-value consumables, Covid-19 personal protective equipment (PPE), such as gowns and face masks, and disposable infusion devices will be under intensified inspection, according to Enhance Quality Inspection for Sterile and Implantable Medical Devices that NMPA published on April 14.
NMPA gives a list of requirements for manufacturers to self-inspect and for NMPA staff to check on-site. The regulations to be based upon, the key manufacturers to be inspected and two examples when inspecting, disposable infusion equipment and ethylene oxide, were also mentioned. For full article please click HERE
Covid-19 Exports under Joint Scrutiny
The Ministry of Commerce, General Administration of Customs and State Administration for Market Regulation (SAMR) jointly announced plans on April 25, to enhance quality inspection and export supervision for COVID-19 related medical devices.
The list of certified non-medical use face-mask manufacturer will be published; the disqualified non-medical use face-mask manufacturers will be provided; Joint Declaration of the Exporter and the Importer, or Export Declaration of Medical Supplies will be required before export clearance. Click HERE for full article
Guideline on Requirements for Adverse Event Monitoring
On April 10, the NMPA issued the Guideline for Medical Device Market Authorization Holders (MAHs) to Conduct Adverse Event Monitoring.
The MAH shall bear the main responsibility for the medical device adverse event monitoring and shall establish a monitoring system. For the eight requirements and six takeaways for manufacturers, please click HERE.
NMPA to Down-Classify Certain Cancer Biomarker Reagents
NMPA will reclassify 29 cancer biomarker-related reagents from class III to class II with an announcement on April 24.
Along with the massive reclassifications of medical devices in August 2017, this proposal is part of the NMPA’s goal to be more dynamically adapting to the market needs to introduce needed device to the market faster. It is trying to balance the risk and benefit more efficiently and faster access to patient needs. For our comments please click HERE.
Standards
12 standards were published in April, impacting local type testing for gynecological, dental and assisted reproduction devices and equipment sterilization methods:
For full list of standards issued in April, please contact info@ChinaMedDevice.com.
Innovative Approval
Edwards Lifesciences Obtained Innovation Status
NMPA granted three innovative device approvals and five innovative devices status in April. Among them is one imported device, transcatheter valve repair clip from Edwards Lifesciences.
NMPA utilizes fast-track approval pathway for medical devices with innovative status. The granted priority manifests in the classification determination, pre-clinical testing, QMS auditing, and NMPA reviewing/approving processes. Meanwhile, the specially-assigned NMPA officers would check in and provide guidance throughout the whole expedited process. For full article click HERE.
About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA 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.