Pacific Bridge Medical

Join Pacific Bridge Medical for a webcast on 2012 NEW Korean Medical Device Regulatory Changes on May 3rd!

Korea’s device regulations are changing rapidly. In 2012, there are new regulations for pre-market approval, classification, GMP certification, exemptions on KFDA review, etc. Registering your product can be very difficult in Korea; therefore, understanding the latest regulatory issues is key to being successful. This webcast will focus on the new Korean medical device regulations. This 90-minute session will include a 60-minute presentation, followed by 30 minutes of Q&A.

Click here to sign up now!

Join Pacific Bridge Medical for a webcast on Hong Kong Medical Device Regulatory Updates on April 17th!

Currently, Hong Kong has a voluntary medical device registration list. However, the Hong Kong government is planning on making product registration mandatory for medical devices soon. Getting on Hong Kong’s voluntary list now will ease the transition to mandatory product registration and give applicants a far shorter waiting time. Get a head start by attending our webcast and familiarize yourself with Hong Kong’s medical device regulations. The speakers is Pacific Bridge Medical’s executive in our Hong Kong office. Real case studies will be used to emphasize key points. This 90-minute session will include a 60-minute presentation, followed by 30 minutes of Q&A.

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Pacific Bridge Medical will host a webcast on March 15 focusing on changes in Taiwan’s medical device market.

Taiwan’s medical device market is Asia’s fourth largest at $1.7 billion. Taiwanese FDA regulations are changing and the requirements for QSD, product registration and reimbursement are getting more complex.

Register for this webcast to make sure you know all the regulatory hurdles and the medical device environment to capture the most of Taiwan’s cost-savings potential and market.

Click here to sign up now!

For more information, publications, reports and upcoming webcasts visit: http://www.PacificBridgeMedical.com

Pacific Bridge Medical (PBM) has opened two new offices — one in Singapore and one in Hong Kong. This means that PBM can now act as legal agents in both countries. When companies market medical devices or pharmaceuticals, it is helpful and may be important to have an independent in-country representative as a registered legal agent. Legal agents deal with the government for vital processes such as product registration and renewal, adverse event reporting, etc.

A leading consulting company specializing in business expansion for medical companies in Asia, PBM was founded in 1988 by Ames Gross. Since then, PBM has worked with over 200 business entities to develop their success in the Asian markets. With over 20 years of experience, PBM is dedicated to developing strategic solutions for businesses in Asia.

Pacific Bridge Medical (PBM) is now licensed to act as third-party local representation under the Marketing Authorization Holder (MAH) system in Japan and as a Legal Agent in China.

The MAH system is significantly stricter than the previous In-Country Caretaker (ICC) system. Only local entities in Japan qualified as MAHs may import and sell medical products in the Japanese market. In order to qualify as an MAH, an entity must be equipped to handle quality assurance and post-marketing safety management for its imported medical product s. A MAH may be a foreign firm’s distributor, its own local Japanese branch or subsidiary, or an independent third party contracted to fill the role. This latter position is referred to as a Designated Marketing Authorization Holder, or D-MAH, which PBM is qualified to act as.

PBM is also qualified to act as a Legal Agent in China. When marketing a drug or medical device in China, even if it is through a Chinese distributor, it may be important to have an independent in‐country representative that is a le gal entity registered in China. This representative serves as the required local entity that deals with the government regarding product registration and renewal, adverse event reporting, etc. Using an independent third party allows for confidentiality of technical information and means less reliance on a distributor.

A leading consulting company specializing in business expansion for medical companies in Asia, PBM was founded in 1988 by Ames Gross. Since then, PBM has worked with over 200 business entities to develop their success in the Asian markets. With over 20 years of experience, PBM is dedicated to developing strategic solutions for businesses in Asia.

Pacific Bridge Medical will host a webcast on November 3rd focusing on changes in the Vietnam medical device market.

Vietnam is a growing medical device market, especially for manufacturing and sourcing as China gets more expensive. Increasingly open for more foreign trade, Vietnam is quickly becoming the next emerging market in Asia with many high-tech companies moving their facilities there.

Register for this webcast to make sure you know all the regulatory hurdles and the medical device environment to capture the most of Vietnam’s cost-savings potential and market.

Click here to sign up now!

For more information, publications, reports and upcoming webcasts visit: http://www.PacificBridgeMedical.com

PBM will be exhibiting at RAPS 2011 (October 23-26, 2011) at the Indianapolis Convention Center in Indianapolis, IN. Look for us at booth #410 to learn more about how we can help your company achieve regulatory success in Asia.

Learn more about the regulatory services PBM offers by contacting us or browsing by topic on our website:

• Regulatory Strategy

• Product Registration

• Reimbursement

• Quality Systems

• Local Representation

• Clinical Trials

Pacific Bridge Medical will host a webcast on October 12th that focuses on succeeding in the competitive Chinese, Japanese and Indian medical markets.

With the US and European business climates in a downturn, the world is leaning towards Asia for growth. Tremendous opportunities abound in the China, Japanese, and Indian medical markets. Understanding how to enter, expand or deal with key regulatory issues in these markets is key to surviving in the competitive global market. From setting up your own branch in Japan to conducting clinical trials in India, this webcast will delve into the key business and regulatory issues in China, Japan, and India. Real case studies will be used to support main points.

Click here to sign up now!

For more information, publications, reports and upcoming webcasts visit: http://www.PacificBridgeMedical.com

Pacific Bridge Medical will host a webcast on September 21st that focuses on new medical device regulations that are coming into effect in Singapore.

The Health Products Acts (HPA) regulates the manufacture, import, supply, and advertisement of health products in Singapore. Originally passed in November 2007, the HPA is being implemented in phases by the Health Sciences Authority (HSA) to minimize the impact on the medical device industry in Singapore. The final phase of HPA is being implemented this year.

For medical device companies who want to sell their products in Singapore in the near future, it would be very smart to take advantage of the HSA’s extended deadline (November 30th, 2011)! Otherwise, you may need to wait months/years to sell in Singapore.

Click here to sign up now!

For more information, publications, reports and upcoming webcasts visit: http://www.PacificBridgeMedical.com

Next week, Ames Gross will present key opportunities and challenges to pharmaceutical business development in Asia at the iiBig Pharma Sales & Marketing Conference in Baltimore. Stop by the Inner Harbor Marriott on the second conference day (Wednesday, November 17th) to hear about getting your drug product to the Asian markets and ensure its success.

Check out the conference schedule here.

Learn more about business development in Asia on our website.