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A Record of Changes Marked August NMPA (CFDA)

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Monthly NMPA (CFDA) News Roundup (August)

Monthly NMPA (CFDA) News Roundup covers government announcement, policies, standards, guidelines, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC (chinameddevice.com), a consulting firm specializing in China NMPA (CFDA) regulatory, CRO and market access services.

Highlights:

  1. Second round UDI feedback has been requested by NMPA (CFDA), to adequately identify medical devices through their distribution and use in China.
  2. NMPA (CFDA) accelerates its effort in post-market surveillance, following the vaccine scandal with the demotion of major NMPA (CFDA) leadership.
  3. Registration Holder system newly-initiated in two provinces, after successful piloting in Shanghai.
  4. IVDs stand for 25% NMPA (CFDA) new approvals, and 3 IVD guidelines issued.

Policy

  1. NMPA (CFDA) announced Unique Device Identification (UDI) draft plan on August 22. Feedbacks need to be submitted by September 21, 2018. This is the second round of UDI feedback requested by NMPA (CFDA) .

When fully implemented, the label of all devices in China will include a unique device identifier in human- and machine-readable form. Within 60-day grace period, the license holder of the medical device shall upload the product identification and related data to NMPA (CFDA) UDI database.

For more information about the UDI draft plan, please click HERE.

For English version of the draft plan, please email info@ChinaMedDevice.com.

  1. NMPA (CFDA) issued Decree No.1 for Medical Device Adverse Event Reporting on August 31. More control, strictness and timely post-market surveillance will be enforced. The major changes from previous regulation include:
  • Provincial NMPA (CFDA) offices will take major responsibility for surveillance, instead of National Test Center as in the past. It means more staff and quicker action for “fly-inspection”.
  • Overseas adverse events are required to be reported, and the report must be conducted by local legal agent.
  • Adverse event records shall be kept 2 years after the expiration date; 5 years if no expiration date provided; Implantable device registration holders shall keep the records permanently.
  • Yearly Risk Analysis becomes mandatory.
  • Penalties, such as stopping production, suspension of importation and fines, are specified for the first time.

For more information about the Decree, please click HERE.

For official NMPA (CFDA) link of the Decree, please email info@ChinaMedDevice.com.

  1. NMPA (CFDA) published 2018 Medical Device Industry Standard Revision Plan on August 7th. Industry standard of 99 devices, IVDs and their quality system will be available by end of this year, some of which have already been issued so far.

The standards also specify the modifications, effective dates, and give recommendations for registration application. NMPA (CFDA) will issue standards in 20 days after adoption, for the betterment of transparency of regulatory operation.

For more information about the Standard Revision Plan, please click HERE.

For official NMPA (CFDA) link of the Plan, please email info@ChinaMedDevice.com.

  1. NMPA (CFDA) announced Initiation for Registration Holder system in Guangdong and Tianjin, after Shanghai’s piloting program started in early January. Registration holder in the three provinces can now be independent of the manufacturer.
  2. NMPA (CFDA) issued Modified Requirement for Medical Device Renewal Registration. Issues including registration material, legal agent and multi-center trial have been addressed.

Government Announcement

3 NMPA (CFDA) national chiefs and 7 provincial leaders have been demoted on August 16, as result of the recent vaccine scandal. Public awareness and government alertness over QMS system have been elevated to a new level.

For more information about the demotion, please click HERE.

Guidelines

NMPA (CFDA) issued 7 guidelines including 3 for IVDs:
Technical Review Guideline on Nasogastric Tube
Technical Review Guideline on Disposable Sterile Catheter
Technical Review Guideline on Custom Denture
Technical Review Guideline on Intrauterine Device
Technical Review Guideline on Methicillin-Resistant Staphylococcus Aureus (MRSA) Reagent
Technical Review Guideline on Chromosomal Abnormalities Detection Reagent
Performance Evaluation Guideline of Next Generation Sequencing (NGS) Based Cancer Biomarker

For official NMPA (CFDA) link of any guideline mentioned above, please email info@ChinaMedDevice.com.

QA/Recall/AE

  1. NMPA (CFDA) announced recall notices for 11 imported medical devices and IVDs. Johnson & Johnson, Philips, GE, Medtronic and 7 others are on the list.

Johnson & Johnson: Contact lens
Philips: Mobile digital x ray machine
GE: Single-photon emission computed tomography
Medtronic: Disposable cutterhead
DePuy Orthopaedics: Artificial knee joint
BioMérieux: Gram-positive bacteria flashcard (class I recall)
Biomet Orthopedics: Knee joint
Zimmer: Metal intramedullary nail
Mako Surgical: Orthopedic surgery navigation system
Arrow: Central venous catheter
Teleflex Medical: Disposable laryngeal tube

For the reasons of recall and the model numbers, please email info@ChinaMedDevice.com.

  1. NMPA (CFDA) announced Voluntary Registration Withdrawals during December 15, 2017 to June 25, 2018. 139 medical devices and IVDs have been voluntarily withdrawn due to incorrect clinical data and noncompliance with clinical trial regulation. Beckman Coulter, Roche, Boston Scientific, Smith & Nephew and St. Jude are on the list.

For more information about Clinical Inspection, please click HERE.

New Approval

  1. NMPA (CFDA) published Approvals of Medical Devices for July 2018. 45 domestic class III, 17 imported class III and 23 imported class II medical devices and IVDs have been approved. GE, Roche, Boston Scientific, Life Technologies (US), and Edwards Lifesciences are on the list. Among them are 21 IVD manufactures, accounting for 25% of total approval.
  1. NMPA (CFDA) granted Innovation Approval status to a domestic manufacturer.

Aipute: Anchor Balloon Dilatation Catheter

For complete English version of the guideline, please email info@ChinaMedDevice.com.

Keep yourself updated with NMPA (CFDA) News Roundup, click HERE to opt-in. For market access newsletter, click HERE. For CRO services in China, click HERE.

About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our NMPA (CFDA)  regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ NMPA (CFDA) certificates and 250+ companies’ success.

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