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Topics covered in Pacific Bridge Medical's December eNewsletter include:

• Major changes to the Philippine FDA
• Rapid growth in the Singaporean med-tech industry
• International standards for Taiwanese FDA documents

Pacific Bridge Medical's November eNewsletter includes such topics as:

• Plastic and cosmetic surgery in China
• Universal healthcare in Indonesia
• Changes to the Japanese PMDA's consulting sessions

Topics in this newsletter include:

• Child diabetes in China
• Safety and quality standards in Korea and Indonesia
• Collaboration on orphan drugs between Japanese and EU regulatory agencies

Topics covered in this newsletter include:

• China's tightened controls on foreign medical device labeling 
• Low risk medical devices to be sold virtually in Taiwan
• Increased use of generic drugs in Japan

Join Pacific Bridge Medical for a webcast on India Medical Device Regulatory Updates Webcast on June 20th at 11:30 EDT!

India’s medical device market is exploding! India combines many opportunities and many challenges for the medical device industry. India’s medical device market is currently the fourth largest market in Asia and is worth over $3 billion. With a projected growth 15% over the next five years, one cannot ignore India’s potential and vast market opportunity. This webcast will provide an overview of India’s most recent medical device regulations. This 90-minute session will include a 60-minute presentation, followed by 30 minutes of Q&A.

What you will learn:

• India’s healthcare system
• India’s medical device market
• Regulatory environment – Regulators of medical devices
• Medical devices which need to be registered now
• New medical device regulations and proposed legislations
• New product registration requirements
• Registration process
• Manufacturing License
• Quality Assurance (QA)
• Good Manufacturing Practice (GMP)
• Labeling and packing
• Price control
• Others

Click here to sign up now!

Some of the topics covered include:

• Significant sales increases projected for generic drugs in Asia
• Price controls for drugs in India
• Important changes to the Korean Medical Device Act

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) 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 products. 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 DMAH, 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 legal 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.