NMPA (CFDA) Roundup 201907

24 Industry Standards in July: Time to Update Your Design Control
August 2, 2019
NMPA (CFDA) GMP for Software: Eight Requirements You Must Follow
August 13, 2019

NMPA (CFDA) Roundup 201907

The Monthly NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recalls/AEs, and new approvals in medical devices and IVDs in China. It is edited by ChinaMed Device, LLC (www.ChinaMedDevice.com), a consulting firm specializing in China NMPA (CFDA) regulatory affairs, CRO and market access services.

Keep yourself updated with NMPA (CFDA) News Roundup, click HERE to opt-in.

Highlights:

  • Unique Device Identification (UDI) System Implementation Plan

Cardiac implants, brain implants and prothesis as the first trial

  • 2019 First Batch of Medical Device Classification Results

Some are classified as medical devices for the first time

  • Good Manufacturing Practice Annex on Standalone Software

Eight special requirements for software manufacturers

Policy

  1. NMPA (CFDA) and National Health Commission announced the Unique Device Identification (UDI) System Implementation Plan on July 7. High risk implanted devices, such as cardiac implants, brain implants and prothesis, are included as the first trial, according to the UDI Plan. Participants include overseas and domestic Marketing Authorization Holders (MAHs), manufacturers, distributors, user facilities, research institutes, device labeler, etc.

The UDI system has been established to “adequately identify medical devices through their manufacturing, distribution and use in China”. The label of all devices in China will include “a unique device identifier in human- and machine-readable form, benefiting traceability in product registration, clinical, adverse event reporting, recall and medical insurance.”

For our comments on the UDI implementation plan, please click HERE.

2. National Institutes of Food and Drug Control (NIFD) published the First Batch of Medical Device Classification Results on July 18. This document, classifying Class III (56 items), Class II (78 items), Class I (53 items) and Non-Medical Devices (5 items), serves as a guide to manufacturers for ambiguous device classifications.

The Classification Results involves devices in anesthesiology, cardiovascular, dental, gastroenterology and urology, obstetrical and gynecological, ophthalmic, orthopedic, pathology and molecular diagnostics.

Some are classified as medical devices for the first time. For example, the regulatory status of some cosmetic devices, including ultrasonic skin treatment equipment, ultrasonic electrical stimulation device and electrotherapy ultrasound therapy device, is changed from non-medical device to Class II device.

For our comments on the Classification Results, please click HERE.

3. Center for Medical Device Evaluation (CMDE) issued Notice on Requirements for Medical Device Electronic Submission on July 10. It lists three requirements which are to be implemented on August 1, 2019.Center for Medical Device Evaluation (CMDE) issued Notice on Requirements for Medical Device Electronic Submission on July 10. It lists three requirements which are to be implemented on August 1, 2019.

a. When registering imported device, only the probative documents, declaration of conformity and labels shall contain the notarized documents issued by the notary body at the place where the applicant is located;

b. Considering the folder structure of Regulated Product Submission Table of Contents (RPS ToC), the page number of the registration materials under the heading of any level can be compiled separately;

c. The Technical Requirements in the electronic registration application materials should be contained in a single copy.

For our comments on these requirements, please click HERE.

Guideline

NMPA published Technical Review Guideline on Dental Digital Impression Instrument on July 4. It contains the Product Technical Requirements (PTRs) and PTR template for reference.

Standards

NMPA announced establishments or revisions of 24 Medical Device Industry Standards on July 30.

  • Surgical sheets, surgical and cleansing suits for patients, medical staff and equipment – Part 8: Product-specific requirements
  • In vitro diagnostic medical device Information provided by the manufacturer for in vitro diagnostic reagents for biological staining
  • Ultrasound bone densitometer
  • Medical device genotoxicity test – Part 3: TK gene mutation test using mouse lymphoma cells
  • Medical device genotoxicity test – Part 6: In vitro mammalian cell micronucleus test
  • Medical device complement activation test – Part 3: Determination of complement activation products (C3a and SC5b-9)
  • Small aperture connectors for medical fluids and gases – Part 20: General test methods
  • Dental amalgam
  • Human chorionic gonadotropin assay kit
  • Evaluation of immunogenicity of medical devices – Part 6: Determination of spleen lymphocyte subsets in animals by flow cytometry
  • Guide to research on the compatibility of disposable infusion devices with drugs – Part 2: Research on leachables
  • Disposable medical protective shoe cover
  • Disposable medical protective cap
  • Chromosome aneuploidy detection kit for pre-embryo implantation
  • General technical requirements for intravascular ultrasound diagnostic equipment
  • Radial load test method for balloon dilatation and self-expanding vascular stent
  • Acupoint impedance testing equipment
  • Parathyroid hormone assay kit
  • Vibrating and slamming drainage machine
  • Meridian stimulator
  • Basic electroacoustic characteristics and measurement methods of array pulse echo ultrasonic transducer
  • ABO detection card (column agglutination method)
  • Evaluation of neurotoxicity of medical devices – Part 1: Guide to selection of trials for evaluation of potential neurotoxicity
  • UDI system basic terminology

For our comments on these standards, please click HERE.

QA/Recalls/AEs

NMPA announced Recall Notices to five imported medical devices in July:

New Approvals

NMPA granted Innovative Device Status to three manufacturers on July 26.

For English version of Guideline on Innovative Device Approval Procedures, please email info@ChinaMedDevice.com.
For webinar on Post Market Surveillance in China, please click HERE.
Keep yourself updated with NMPA (CFDA) News Roundup, click HERE to opt-in.

About ChinaMed Device, LLC 

ChinaMed 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 (CFDA) 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 (CFDA) 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.