Malaysia Medical Device Registration

Location :

Suite5 Sentral Business Suites， Jalan TKS 1, Taman Kajang Sentral, 43000 Kampong Sungai Kajang, Selangor

Medical Device Registration:
Contact: All Enquiries: (+60) 012-2178662 / 012-7321169
We can undertake product registrations of Medical Devices
- Plan product registration strategy
- Prepare/Review CSDT
- Classification and Grouping
- Submit certificate for verification
- Submit registration dossier for Product Registration
- Manage queries from the authority
- Technical Assistance in GMP, Clinical, Bio Compatibility, Stability, etc

and In-country Representation:
Our network can act as your local Authorised Representative for Malaysia, Singapore, Indonesia and Thailand. We liaise with the regulatory authorities for your products and keeping you updated with changes in the regulatory requirements. This allows your distributors to focus on sales and distribution. Should you need to change distributors, the products which we have registered on your behalf will not be affected.

Post Market Survelliance:
If you need local support for unforseen events such as product recalls, adverse event reporting or field safety corrective actions, talk to us, we may be able to assist.

Add email
Add phone
Add opening hours
Add photos
Add Social Media
Add Products and Services

No reviews yet. Be the first to add a review.