Training–Regulatory affairs

Training–Regulatory affairs

Medicine registration process

API source validation process

In Bangladesh, commercial importers/traders are not allowed to import active pharmaceutical ingredients (APIs). Only the finished formulators having the Drug Manufacturing License (issued by DGDA) are allowed to import APIs with their industrial IRC. IRC means Import registration certificate. Indenting firms are the commissioning agents for promoting the APIs to the Bangladeshi Pharmaceuticals for finished dosage form production.

A local representative/indenting firm/local entity is required to apply the source validation of APIs in Directorate General of Drug Administration (DGDA), Bangladesh. Usually, source validation process takes 30 working days to get the source validation certificate issued by DGDA.

Without having the source validation of the API plant & the APIs in the DGDA database, Bangladeshi purchase managers can not select the API during the Block list preparation. Block list is a format of DGDA to get prior approval of raw materials for import into Bangladesh.

Medical device registration process

Government Authority (DGDA)

The Directorate General of Drug Administration (DGDA) in Bangladesh is the primary regulatory authority, ensuring the quality, safety, and efficacy of pharmaceuticals, medicated cosmetics, medical devices, and health products in the country. DGDA plays a vital role in overseeing the import, production, distribution, and sale of drugs and medical devices, ensuring compliance with rigorous standards.

Medical device status:

The Government of Bangladesh issued the Drug and Cosmetics Act, 2023 which is effective from September 18, 2023 formalizing the requirements for medical devices, IVD reagents and adding software to the definition of medical devices. Medicated cosmetics are under the jurisdiction of DGDA now.

Classification:

Medical devices are classified into 4 categories; A, B, C, and D based on risk level.

Registration process:

Import Licenses for Class B, C, and D devices require a 2-step registration process. The first step is Primary approval and is locally called the Recipe registration. This step requires all documentation and occurs once per quarter. Once the Recipe approval (i.e., primary approval) letter has been issued, the application then enters the Final registration process where the original documents (CFS, EC Certificate and ISO 13485 certificate) are reviewed.

European CE Marking is required with Certificate of Free Sale (CFS) and ISO 13485 expected. Product codes included on a License are based on the leveraged CFS and therefore, grouping often follows the product codes listed on the CFS but can become complicated depending on their classification and how they’re sold.

Class B, C, and D Licenses are valid for 5 years and can be renewed in about 2 to 3 months with a fee of ~USD120. Class A Licenses do not expire.

Quality system requirements:

Class B, C, and D devices all require ISO 13485 certificates to certify the quality system/s of the legal and/or actual manufacturing facilities.

License Holder requirement:

Import Licenses are issued to a local, licensed company that will own and represent the manufacturer. Multiple license holders for the same device at the same time are not permitted. 3rd party license holders (i.e., registration holder) can be appointed. Then manufacturers can appoint multiple distributors/importers.

Importing

The License Holder does not need to be a part of the importing process unless needed. Manufacturers are able to work directly with their distributor(s) for importation. However, the license holder (Pharma DRA) will need to issue a No Objection Certificate (NOC) for each importation.

License transfer:

Manufacturers are able to transfer licenses, but the original registration certificate is required to complete the transfer process. Original registration certificates are typically held by the license holder and without their support, license transfers are not possible. There is no processing fee for transferring a license.

Benefits of using Pharma DRA as registration holder

1. Multiple distributor can be appointed

2. Regulatory compliance can be maintained easily

3. Authentic service provider since 2016

4. Add or change distributors as required

5. Keep intellectual property away from local commercial agents

Contact Pharma DRA for assistance with your medical device registration in Bangladesh or to confirm the cost and timelines that apply to your specific devices of interest. Pharma DRA has experienced, bi-lingual consultants in Bangladesh to help you manage the application, importing, and post-market surveillance needs.