CFDA adjusts approval procedures for drugs and medical devices

In order to optimize the evaluation and approval procedures for drugs and medical devices, and improve evaluation and approval efficiency, China Food and Drug Administration (CFDA) recently issued The Decision of China Food and Drug Administration on Adjusting Some Administrative Approval Procedures for Drugs (CFDA Order No. 31), and The Decision of China Food and Drug Administration on Adjusting Some Administrative Approval Procedures for Medical Devices (CFDA Order No. 32), to adjust CFDA’s administrative approval procedures for the approval of clinical trials, the approval of re-registration and registration renewal, and the approval of registration alteration of drugs and medical devices.

China CFDA releases 2016 Drug Review Annual Report

China Food and Drug Administration (CFDA) recently released the 2016 Drug Review Annual Report. The Annual Report describes the general situation of drug registration acceptance, review and approval in 2016, and analyzes the data of acceptance and review in 2016 for chemical drugs, traditional Chinese medicines and biological products respectively.

Denttio warned by FDA for violating MDR procedures

FDA issued warning letter to Denttio Inc, in which FDA cited 12 violations to regulations. These regulations include but not limited to

1.    Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR 820.198(a).
2.    Failure to establish procedures for corrective and preventive action as required by 21 CFR 820.100(a).
3.    Failure to establish a design history file as required by 21 CFR 820.30(j).
4.    Failure to perform device software validation and risk analysis as required by 21 CFR 820.30(g).
5.    Failure to maintain device master records as required by 21 CFR 820.181.
6.    Failure to establish procedures for finished device and incoming product acceptance as required by 21 CFR 820.80.
7.    Failure to establish Device History Record procedures as required by 21 CFR 820.184.
8.    Failure to adequately establish procedures to ensure equipment is routinely calibrated, inspected, checked, and maintained as required by 21 CFR 820.72(a).
9.    Failure of management with executive responsibility to review the suitability and effectiveness of the quality system as required by 21 CFR 820.20(c).
10.    Failure to perform quality audits as required by 21 CFR 820.22.
11.    Failure to adequately establish procedures for training and identify training needs as required by 21 CFR 820.25(b).
12.    Failure to establish document control procedures as required by 21 CFR 820.40 (a).
The warning letter is available on FDA website.

EU Council and Parliament will amend MDD and IVDD

Final drafts of the Medical Devices Directive (MDD) and In-vitro Medical Devices Directive (IVDD) have now been published. The regulations will be voted on by the European Council on 7 March 2017 whilst the European Parliament on 20 March 2017, and are expected to be officially published in late April or early May.

Copies of the final drafts can be downloaded from below link:

-Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

-Position of the Council at first reading with a view to the adoption of a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

For more documents on medical devices, please visit the download archive page.

China issues five-year plan on food and drug safety

Two five-year plans (2016-2020) on food and drug safety were issued by the State Council on Feb 21.

According to the food safety plan, China will set stricter standards as well as strengthen supervision and punishment for law violators.

The plan outlines that by 2020 sample tests should cover all kinds of food, especially pesticides and veterinary drugs.

The plan on drug safety outlines that by 2020 the quality of drugs should be further improved, the standard of medical equipment will be raised and the level of supervision will be enhanced.

More information is available from Brückenkopf GmbH website.

Medical Device Reporting for Manufacturers, Guidance for Industry and Food and Drug Administration Staff (FDA)

The guidance outlines manufacturer’s responsibilities for reporting adverse events to FDA. Unless exempted, manufacturers must implement written procedures addressing Medical Device Reporting (MDR) requirements. Guidelines for follow-up investigations and addressing event reports in the medical or scientific literature are included.