Registrasi Produk Alat Kesehatan – Studi Kasus EOS Lens

Problem

Headquartered in Korea, EOS Company Limited is a company established in the year 2002. The company manufactures soft contact lenses through the 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.

Solution

InCorp delivered consulting 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 holders. EOS Lens needed to complete several steps during the product registration, including class assignation, evaluation, and verification of their product.

InCorp provided document 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. InCorp 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 holders, etc.

Since EOS Lens did not have any local partner when it came to the country, InCorp 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, InCorp provided EOS Lens end-to-end assistance to ensure that they complied with local regulations and standard processes.

InCorp Services

EOS Lens appointed InCorp as its main consultant for their product registration and product license holder registration. InCorp provided full assistance by ensuring EOS Lens was equipped with the market regulation knowledge of the country. InCorp provided the following services during the initial stage:

• Product Registration
  • Class Assignation for the product
  • Evaluation
  • Verification
• Product License Holder
  • Legal documentation, import licensing, and invoicing
  • Custom and clearance processes

Result

Since EOS Lens did not have any local partner when it came to the country, InCorp 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 its products through more than one distributor in Indonesia, allowing them to achieve greater market efficiency. Furthermore, their product registration was finished in a timely manner.

Challenge and Cross Services

Because the medical product registration required significant documentation, InCorp and EOS Lens had to be in constant collaboration to ensure the timely and accurate processing of all requested documents required by local regulations. InCorp helps to ensure that the submission of documents is on time to avoid extra costs and delays during the process. InCorp utilized its dedicated and professional product registration team specializing in handling the registration process.