Medical Device Registration
Our in-house experts will compile your technical documents and prepare customized dossiers such as the CSDT for medical device registration in Malaysia. We are experienced in liaising with the Conformity Assessment Body (CAB) for Full Conformity Assessment and/or Verification. We also have a proven track record of completing dossiers efficiently with minimal questions and feedback received from MDA.
Utilize our intimate industry knowledge and expertise to obtain registration approvals for your medical device in Asia.
Product registration in Asia can be a daunting task. Each Asian country has its own unique product registration requirements and classification systems.
Shinteklogy can assist you in registering your medical device products. Our regulatory consultants are diligent in preparing and reviewing medical device registration documents. We will take the following steps to minimize additional documentation requests from the approval body and other delays:
- Meticulously educate ourselves on your medical device specifications.
Depending upon the classification of your medical device and current stage of development, there are a variety of submissions that may be required by the approval agencies in each Asian country. - Analyze the dynamics of registering your medical device in your target Asian market.
Medical device registration is a seemingly simple process of submitting applications and supporting documents to the appropriate regulatory bodies of each Asian country. However, a deep understanding of the applicable regulations and complex requirements — which are significantly more extensive than what is available in published resources and tutorials — is essential to ensuring that your submissions comply with the regulations. - Conduct a gap analysis (if required)
- Determine if local clinical trials are needed for registration
- Prepare and manage regulatory documentation as required.
We will review the dossier and other documents, including documents related to quality management system compliance, foreign manufacturer accreditation, etc. - Address any questions or requests from the Asian government agency.
We will schedule and attend in-person meetings with the approval agency on behalf of the client. - Obtain approval and send the final registration approval certificate to the client.
If your initial registration dossier fails to effectively address certain regulatory concerns, the process for registering your medical device could be lengthened significantly.
We will assist you in registering your medical device as efficiently as possible.