Last month some vital regulations were released by China NMPA (CFDA). Please see below NMPA Newsletter, covering government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China.
Highlights:
- Market Authorization Holder (MAH) System
18 provinces began to implement contract manufacturing
- Clinical Trial Exemptions Draft Catalog
40 Class III devices and 14 Class III IVDs are on the list
- Beijing IVD Inspection Plan
13 requirements for IVD manufacturers to follow
Policies
- NMPA published the Extension of Pilot Program for Market Authorization Holder (MAH) System on August 1, introducing the MAH system for 18 provinces including the booming med-tech markets of Beijing, Zhejiang, Jiangsu and Shandong. The policy is already in effect in three provinces, Shanghai, Guangdong and Tianjin.
Companies that register devices do not have to be the manufacturers. They may commission one or multiple qualified contract manufacturing organization(s) to manufacture the approved medical devices.
The document also clarified responsibilities for MAH and Contract Manufacturer:
MAH:
- Legally responsible for product design, clinical trial, manufacturing, sales and post-sales, recall and adverse event reporting, etc;
- Sign Letter of Authorization and Quality Agreement with contract manufacturer(s), and clarify both responsibilities in Product Technical Requirement (PTR), quality assurance and dischargement;
- Conduct periodical GMP audit for conduct manufacturers;
- Ensure device traceability and conduct adverse event monitoring;
- Ensure data authenticity in clinical trial or clinical evaluation report (CER)
Contract Manufacturer:
- Perform obligations specified by "Medical Device Supervision and Administration Regulations", Letter of Authorization and Quality Agreement;
- Responsible for MAH on device quality;
- Report quality issues to provincial NMPA where it locates.
For more info on China MAH, please click HERE.
- NMPA published the Clinical Trial Exemptions Catalog for Medical Devices (Draft) on August 1, 2019, in an effort to implement risk-based clinical evaluation, and to make medical device clinical exemptions more consistent with internationally-accepted standard. It also calls for manufacturers' opinion on the clinical exemption status.
The draft Catalog added exemptions for 142 medical devices, including 40 Class III; It added exemptions for 42 IVDs, including 14 Class III. If implemented, a total of 996 medical devices and 420 IVDs will be exempted from clinical trials in China since the first exemptions catalog in 2014.
- NMPA published the Good Manufacturing Practice Annex on Standalone Software. After satisfying Good Manufacturing Practice on Medical Devices, software manufacturers must meet the eight special requirements listed in the Standalone Software Annex:
- Personnel
- Equipment
- Design development
- Procurement
- Manufacturing management
- Quality management
- Sale and after-sale
- Adverse event monitoring and analyzing
NMPA also states that three already issued guidelines can be used as references for standalone software registration:
- Software Technical Review Guideline
- Cyber Security Technical Review Guideline
- Mobile Device Technical Review Guideline
- Beijing NMPA office published the Beijing In Vitro Diagnostics Inspection Plan on August 1, specifying the requirements in IVD inspections from August 16 to October 11:
- Registration Certificate: if it manufactures without certificate
- Inspections in the past two years: if it rectifies all the defects
- Quality Management System: if it is well-established
- Manufacturing equipment, process equipment, inspection instruments: if they match the products and the scale produced, and ensure effective operation
- Supplier audit system: if it complies with "Guidelines on Suppliers Verification for Medical Device" and maintains effective operation
- Quality agreement with major raw material suppliers: if it clarifies the quality responsibilities of both parties
- Procurement records: if it meets the traceability requirements
- External procurement of standard products, calibrators, quality control products, production or quality control blood: if it meets the traceability requirements
- Mandatory standards and the technical requirements: if they are satisfied with registered or filed products
- Quality control procedures: if each batch of products has batch inspection records and meets traceability requirements
- Product manual and labeling: if it complies with relevant laws, regulations and standards
- Sale records: if they meet traceability requirements
- PMS system: if it implements a system for monitoring, analyzing and improving adverse events, and whether recalls are taken without potential safety hazards, and reports are made to relevant departments
IVD companies with large sales volume have been put into priority monitoring for which intensified and unannounced inspections can be expected.
Guidelines
NMPA published seven draft guidelines in August:
- Animal Study Guideline on Bioabsorbable Coronary Artery Drug Eluting Stent
- Clinical Trial Guideline on Hernia Repair Patch (draft)
- Technical Guideline on Mechanical Interaction Quality Control for Custom Bone Implants and Supporting Tools (draft)
- Technical Guideline on EB Virus Nucleic Acid Detection Reagent (draft)
- Technical Guideline on Finite Element Analysis Data of Orthopedic Metal Implants (draft)
- Registration Guideline on Total Knee Prosthesis System (draft)
- Registration Guideline on 3D printed Patient Matching Mandibular Prosthesis (draft)
QA/Recalls/AEs
NMPA announced Recall Notices for 22 imported medical devices in August:
Class I recalls (the most serious recall class):
- GE: Infant radiant warmer
- Edwards Lifesciences: Intra-aortic occlusion device
- Jude Medical: Tiered-therapy cardioverter/defibrillator
- Datascope Corp: Intra-aortic balloon pump
- Teleflex Medical: Tracheal Tube
Class II & III recalls:
- Siemens: Ferritin Flex reagent cartridge (FERR)
- Siemens: Anti-CCP IgG reagent
- BD: Automatic microbial sample processing system
- BD: DNA extraction kit
- Maquet Cardiopulmonary: Artificial blood vessels
- Maquet Cardiopulmonary: Medical heater
- GE: Ultrasound diagnostic apparatus
- Philips: Patient monitor
- Medtronic: Disposable blur
- Boston Scientific: Cardiac ablation system
- Varian: HDR Brachytherapy afterloader
- Teleflex Medical: Nurse hair clip
- CareFusion: Bone marrow biopsy needle
- Codman & Shurtleff: Medical tweezer
- American Medical Systems: Urinary control system
- Nobel Biocare: Dental implantation system
- Howmedica Osteonics: Knee prosthesis
New Approvals
- NMPA granted Innovative Device Status to a software on August 30.
- Shanghai Yingtong: Diabetic retinopathy analysis software
- NMPA granted Priority Review Status to a medical device on August 30.
- Beijing Xianruida: Drug-eluting peripheral balloon dilatation catheter
For those of you that are considering MAH contract manufacturing, or wanting to utilize clinical exemption, I'd love to hear your thoughts!
If you have any questions or want to know more, feel free to reach out to me via message or email gpalma@ChinaMedDevice.com.
Thanks!
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------