MEDICAL DEVICES CONSULTING
The FDA requires any foreign manufacturer who intends to sell their products in the United States of America (USA) to retain a US Agent with a physical address within the USA. An Official Correspondent is someone designated with the responsibility for communicating with FDA. GRP can be your US agent and we can provide following services:
- Assist FDA in communication with the foreign manufacturer/establishment.
- Respond to questions from the FDA regarding the foreign establishment’s devices that are offered for import into the US.
- Assist FDA in scheduling inspections of the foreign manufacturer.
- The US Agent responsibilities do not include reporting adverse events (under 21 CFR 803 Medical Device Reporting (MDR) regulations), however, GRP offers specialized services in this regard.
- Initial Registration of a new Establishment via the on-line FDA Unified Registration and Listing System (FURLS).
- Facilitate processing of Client’s payment of the FDA Establishment Registration Fee (annual requirement)
- Initial Listing of medical devices that will be imported into and marketed in the US.
- Update the on-line Registration and Listing records annually as required by FDA and as needed.
- Provide an importation letter template, as requested, to facilitate importation.
- Provide notifications and updates from the FDA regarding changes to the Registration and Listing requirements.
Local Representation in China and Japan
To be able to conduct business in China and Japan, foreign Medical Device companies must have a local agent or representative who assumes the legal, regulatory and compliance responsibilities locally on their behalf.
Selecting the appropriate local agent or representative in China and Japan, that you can trust with your confidential information, who understands and respects the policies and values of your company and who will on your behalf defend your local interests is becoming very challenging and a risky process.
In China and Japan, foreign companies can choose one of the following three options to select a local agent who can represent them locally:
Appoint Local Distributor as your Local Agent
- Quick process to set up.
- No large investment up front.
- Your products are registered under distributor’s name and you have less control of your sales and marketing.
- Problems may arise if you decide to end the relationship with your local distributor for underperformance or other reasons.
- May need to pay a lot of money to distributor so they will transfer to you the registration under your name.
- When transferring the existing registrations, you will have to re-register your product and undergo the entire approval process from the beginning, which would be very costly and time-consuming.
Invest and Set up a Local Branch or Subsidiary Office
A local branch or subsidiary office will allow you to hold the product registrations in your company’s name and thus give you more control of your sales and marketing.
High investment up front and this option may be more suitable for medium to large-sized pharma/biologic companies.
Appoint an Independent Local Agent .
- Quick process to set up.
- No investment up front.
- Products registered under your company’s name so you keep control of your products’ registrations.
GRP can act as your Local Agent in China and Japan so you can keep control of your products’registration
As your independent in-country local agent, GRP China and GRP Japan can handle the following activities on your behalf:
- Protect your confidential information.
- Register your products in a timely manner under your name.
- Represent your company with Chinese and Japanese health authorities (CFDA and PMDA).
- Interact with CFDA and PMDA on all regulatory issues on your behalf.
- Manage the lifecycle of your products in China and Japan.
- Handle all complaints and recalls activities as needed.
- Report adverse events related to your products to CFDA and PMDA and other regulatory agency if applicable
- Assist your company during the importation process of your products to China or Japan.
- Handle the local quality release of your products before distribution and commercialization.
- Alert your company of new regulations as required.
- Assist with finding the appropriate local distributors for your products.
- Undertake the legal obligations to guarantee your products’ quality
- Acts as your after-sales service agent.
Contact us today to learn more about how we can assist your company with local agent representation.