Find a reliable local agent in Asia that you trust to represent your medical device or pharmaceutical product.
In Asia, there are normally three options for choosing a local agent to represent your medical product:
- Have your local distributor act as your agent and apply for product registrations in the distributor’s name.
However, a potential problem that may arise is that 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. In addition, you will have to re-register your product and undergo the entire approval process from the beginning, which can be very costly and time-consuming.
- Invest in setting up a local office in a specific Asian country.
This will usually be a branch office or subsidiary office. A local branch or subsidiary office will allow you to hold the product registrations in your company’s own name and thus give you more control of your sales and marketing. This option may be more suitable for medium to large-sized medical device companies.
- Have an independent legal entity or agent in each country hold the product registrations in your company’s name, for a fee.
The in-country local agent systems differ in each Asian country; thus, it is essential to determine in advance whether this strategy is cost-efficient. In addition to acting as your local representative and helping with product registration, an independent legal entity or agent can assist with post market surveillance, adverse events, etc.
Pacific Bridge Medical can act as your local agent in all the Asian markets
We have served as a local agent for numerous medical companies across Asia in the last 27 years. As your local agent, we can provide the following services:
- 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 as required.
If you are looking for local agent representation for your medical product, contact us now for a free consultation with our Asia regulatory specialists.
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