Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Global View: Talking Harmonization And China With Jeffrey Gren

This article was originally published in PharmAsia News

Executive Summary

The just-retired Commerce official Jeffrey Gren discusses the impact of globalization on the medical device industry, and the issues the sector is facing in China.

You may also be interested in...

‘Made In China’ Provision Removed From Green Channel Policy

The original draft of an accelerated approval policy in China for innovative devices included a condition that a product being considered for the special pathway “is produced in China.” That condition has been removed from the latest draft following pressure from the U.S. government.

FDA’s ISO Audit Program Chugs Along; May Be Absorbed By IMDRF Single-Audit Initiative

Thirty manufacturers have used FDA’s ISO 13485 voluntary audit program since the two-year pilot began last June, freeing up scarce agency inspectional resources to be used elsewhere. However, it will likely be eventually absorbed by a pilot Medical Device Single Audit Program currently under development by the International Medical Device Regulators Forum.

China’s Aim For Centralized Bidding Pressures Medical Device Industry

China’s county-level public hospitals may be required to participate in provincial bidding to purchase medical devices like stents and pacemakers, putting pricing pressure on multinationals such as Boston Scientific, Medtronic and Abbott Laboratories and domestic manufacturers like MicroPort Scientific.

Related Content





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts