With hundreds of happy clients, Cekindo takes pride in having helped foreign firms successfully register their medical devices in Vietnam. Here is a an example:
Headquartered in Korea, EOS Company Limited is a company established in the year 2002. The company manufactures soft contact lenses through casting mold method and provides a diverse range of designs and colors. They have exported their product to more than 40 countries across the world.
EOS decided to enter the Indonesian market in 2016. Since the products of EOS Lens are classified as medical devices, they needed to be registered at the Indonesian Ministry of Health before the company is able to carry out its importation and distribution activities on the product.
Cekindo delivered consultation services to EOS Lens, providing local knowledge regarding regulations and compliances to register its products, including the framing of a business model and product registration under third-party product license holder. EOS Lens needed to complete several steps during the product registration, including class assignation, evaluation, and verification of their product.
Cekindo provided documentation management and assisted EOS Lens in registering their business at relevant government institutions in a timely manner. We assisted EOS Lens in registering their first products before they would be allowed to enter the Indonesian market. Cekindo helped design EOS Lens’ business model with the product registration in Indonesia under the third party to ensure that they can independently coordinate their business in the country such as making future changes related to the distributors, product license holder, etc.
Since EOS Lens did not have any local partner when it came to the country, Cekindo assisted them by acting as their very own product license holder. This scheme allowed EOS Lens to be more flexible in selecting their distributors and partners, minimizing the risks they have to worry about in entering the new market. Further, Cekindo provided EOS Lens end-to-end assistance to ensure that they complied with local regulation and standard processes.
3. Cekindo Product Registration Services
EOS Lens appointed Cekindo as its main consultant for their product registration and product license holder registration. Cekindo provided full assistance by ensuring EOS Les was equipped with the market regulation knowledge of the country. Cekindo provided following services during the initial stage:
- Product Registration
- Class Assignation for the product
- Product License Holder
- Legal documentation, import licensing and invoicing
- Custom and clearance processes
Since EOS Lens did not have any local partner when it came to the country, Cekindo assisted them by acting as their very own product license holder. This scheme allowed EOS Lens to be more flexible in selecting their distributors and partners, minimizing the risks they have to worry about in entering the new market.
EOS Lens is now successfully able to import and distribute their products through more than one distributor in Indonesia, allowing them to achieve greater market efficiency. Furthermore, their product registration finished in a timely manner.
5. Challenge and Cross Services
Because the medical product registration required significant documentation, Cekindo and EOS Lens had to be in constant collaboration to ensure the timely and accurate processing of all requested documents required by local regulation. Cekindo helps to ensure that the submission of documents on time to avoid extra cost and delay during the process. Cekindo utilized its dedicated and professional product registration team specializing in handling the registration process.