Local Representation for Medical Devices and Pharmaceuticals/Drugs in Asia
When marketing drugs or medical devices in Asia, there are normally three "agent" options. The first option is to have your local distributor act as your agent and apply for product registrations in the distributor's name. This, however, comes with potential problems. For example, if you decide to end the relationship with your local distributor for underperformance or other reasons, the distributor may charge a large amount of money to transfer the existing registrations or refuse to transfer them at all.
The second agent option, perhaps more suitable for medium to large-sized medical companies, is to invest in setting up a local office in a specific Asian country. This may be a representative office, a branch office, or subsidiary office. A local branch or subsidiary office will usually allow you to hold the product registrations in your company's own name and thus give you more control of your sales and marketing.
The third option is to have an independent legal entity or agent in each country hold the medical device or drug registrations in your company's name, for a fee. PBM can act as your local agent in all the Asian markets. Please keep in mind that the in-country local agent systems are somewhat different in each Asian country, and it is important to determine whether this strategy is worth the cost. Besides product registration, an independent legal entity or agent can help with post market surveillance, adverse events, etc.
PBM Services – Local Representation
- Register your medical product
- Represent your company with each Asian regulatory agency
- Interact with the Asian government agency on all regulatory issues
- Notify the Asian government agency when there are changes to your products, new manufacturing methods, etc.
- Track all alerts and recalls
- Follow through with complaint handling
- Report adverse events to each Asian regulatory agency properly
- Alert your company of new regulations that are coming soon
Click on the countries below for more information on local representation in each Asian country and/or contact us to discuss your specific needs.