Partner with us for regulatory requirements in Bangladesh. We help manufacturers build sustainable businesses for the long run.
We help manufacture to register medical device in Bangladesh
We help IVD manufacturers to register products in Bangladesh.
We help with food supplement registration in Bangladesh.
We help manufacturers to act as an authorized local representative in Bangladesh
We help to expand business in Bangladesh with proven regulatory strategy.
According to DGDA Medical device guidelines, there are four classes medical device or IVD products in Bangladesh. Those are Class A, Class B, Class C & Class D. Class A refer to lowest risk products and Class D refer for highest risk product.
No. A local agent/registration holder is required to register in Bangladesh.
There are two steps involved to register medical device or IVD in Bangladesh. Step one is recipe/primary approval and step two is final registration.
The registration certificate will be valid for 5 years from the issue date and must be renewal before expires.
Yes, registration holder and distributor can be separate.
For medical device and IVD products, Class B, C & D required around 6 months and Class A required around 30-40 days.
For food supplements that are first time in Bangladesh, it takes 1.5 years to 2 years, and existing approved generics require around 6 months.
Yes, as per DGDA rules, registration holders need to obtain price approval to sell products in the Bangladesh market.
No. One product cannot be registered under more than one company name. You can transfer the registration holder as required.
So, let's be happy together
