Policies

New Clinical Exemptions for 148 Devices and 23 IVDs

Forty Class III devices were added as exemptions to the Clinical Trial Exemptions Catalog for Medical Devices, which NMPA released on December 20, 2019. This final version also added exemptions for 108 Class II devices and 23 IVDs (of which 15 are Class III). Product names and descriptions were amended for 48 medical devices and 4 IVDs.

A total of 1,002 medical devices and 401 IVDs are now exempted from clinical trials in China since the first exemptions catalog in 2014.

Eight Class III Categories that Must Obtain Clinical Approval

As innovation devices and first-of-kind products flood into China market, NMPA seeks to strengthen the clinical-trial approval requirements for certain devices. NMPA published the Catalog of Class III Medical Devices Requiring Clinical Trial Approval on December 23, listing eight categories of devices. 

Guidelines

Eleven Situations where Hainan RWD is Used

Real World Data will become another clinical pathway for device approval in China. Overseas manufacturers can obtain approval for the RWD pilot program, through Hainan provincial NMPA, to start using devices in clinical settings prior to national NMPA approval.

NMPA issued the Guideline on Real World Data (RWD) Used in Medical Device Clinical Evaluation (Draft) on December 13, 2019. The document describes eleven situations when RWD can be used in China.

Conditional Approval with Limited Clinical Data

NMPA recognizes the urgent need for certain devices and IVDs. Those indicated for life-threatening illnesses can be granted Conditional Approval if the benefits of the product outweigh the risks. The manufacturer must also be committed to perform further clinical research.

NMPA’s Guideline on Conditional Approval for Medical Devices, released on December 20, 2019, includes five requirements for manufacturers who wants to get conditional approval.

How to be Qualified for Advisory Committee

Consultation with Advisory Committee is a vital part In FDA and EU approval process. Sometimes they weigh the available evidence and provide scientific and medical advice on the products that regulatory authorities regulate, and then authorities weigh the advice that they receive when taking final actions.

As the publication of Guideline on Expert Panel/ Public Advisory Meeting on December 5, 2019, now Advisory Committee is available in China. 

Standards

NMPA changed status of forty Industry Standards from “Mandatory” to “Recommended” in December 2019.

Although both mandatory and recommended standards are not legally binding, manufacturers better to comply with them in order to expedite type testing and shorten new or renewal registration time.

Recalls

NMPA Announces Recall Notices for 16 Imported Medical Devices

Multiple products from Johnson & Johnson, Boston Scientific, Siemens, Roche and Philips were issued recalls along with 18 other imported medical devices, including two class I recalls. See the full list of companies and recalled devices.

Approvals

Nucleic Acid Amplification Detection Analyzer from Domestic Manufacturer Gains Approval

NMPA granted Innovative Device Approval to nucleic acid amplification detection analyzer, manufactured by Hangzhou Yousida, on December 30.

This product is based on the technology of three-stage magnetic permeation extraction and fluorescent polymerase chain reaction. It is used together with the matching detection kit for the qualitative detection of M. tuberculosis complex group nucleic acids derived from human samples.

Innovative Device Status: Only 20% Claimed by U.S./ European Manufacturers

Of the 39 medical devices granted Innovative Device Status in 2019, only eight (just 20%) were imported devices. Since domestic and overseas manufacturers have equal opportunity for this program, U.S. and European companies may not be taking full advantage.

Source from: “NMPA News Roundup December 2019”China Med Device, LLC , 14 January 2020, https://chinameddevice.com/coronavirus-antigen-antibody-reagent/.