Medical Devices Registration in Bangladesh

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MEDICAL DEVICES REGISTRATION IN BANGLADESH
www.mavenprofserv.com
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Overview

1. Bangladesh Medical Device Regulations
2. Medical Device Status
3. Medical Device Classification System
4. Medical Device Registration Process

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Bangladesh Medical Device Regulations
In Bangladesh, the Directorate General of Drug
Administration (DGDA) oversees medical devices
registration. Operating under the Ministry of
Health and Family Welfare, DGDA regulates the
import, production, distribution, and sale of
medical devices, emphasizing quality and safety
standards. DGDAs role is pivotal in ensuring
the efficacy and reliability of medical devices
through stringent oversight and country
registrations.
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In Bangladesh, the Bangladesh Drug and Cosmetics
Act of 2023, enacted on September 18, serves as
the cornerstone of regulatory provisions
governing medical devices and pharmaceuticals.
This legislation addresses crucial aspects such
as manufacturing, importing, distributing, and
selling medical devices, primarily focusing on
ensuring adherence to quality and safety
standards. One significant requirement outlined
in the Bangladesh Drug and Cosmetics Act is the
necessity for medical device registration.
Manufacturers and importers must obtain country
registrations from the appropriate regulatory
authorities.
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Medical Device Status
As of September 18, 2023, the Government of
Bangladesh introduced the Drug and Cosmetics
Act, 2023, outlining regulations for medical
devices, IVD reagents, and software. This act
expands the definition of medical devices, now
encompassing software under drug
regulations According to the Drugs and Cosmetics
Act, 2023, a medical device is defined as
follows Medical device encompasses
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• (a) Various devices such as instruments,
  apparatus, implements, machines, appliances,
  implants, diagnostic reagents (in vitro, in vivo,
  and silico reagents), software, or related
  materials. These are used either independently
  or in combination for specific purposes,
  including
• Diagnosis, prevention, monitoring, treatment, or
  alleviation of diseases or disorders
• Diagnosis, monitoring, treatment, alleviation, or
  assistance for injuries or disabilities

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modification, or support of
(iii) Investigation, replacement, anatomy or
physiological processes

1. Supporting or sustaining life
2. Conception control or medical device
   disinfection
3. Providing information through examining and
   analyzing samples collected from human or animal
   bodies, unaffected by pharmacological,
   immunological, or metabolic actions.

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(b) Additionally, any device or diagnostic
reagent declared by the government, through
notification in the Official Gazette, for this
Act. This comprehensive definition broadens the
scope of medical devices under the regulatory
purview, ensuring the safety and efficacy of
products intended for use in Bangladesh. It
underscores the importance of adherence to
regulations for manufacturers seeking medical
devices registration in Bangladesh.
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Medical Device Classification System
International Classification Risk Level
Class A Low Risk
Class B Low-Moderate
Class C High-Moderate
Class D High Risk
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Medical Device Registration Process
Submission of Applications Document Preparation
Compliance Assessment Inspection
Review and Approval Registration Certificate
Issuance Renewal Post-Market Surveillance
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Application Preparation DGDA Timeline
New Registration 10 Days 4 - 6 Months
Renewal 10 Days 2 - 3 Months
Change Amendment 10 Days 1 Month
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At Maven, our commitment goes beyond offering
exceptional services we prioritize keeping our
clients informed about Bangladeshs evolving
regulatory landscape, especially concerning
medical devices registration. Our proactive
approach ensures clients stay updated on any
pertinent updates, be they changes in compliance
standards or approaching registration
deadlines. We recognize that compliance is just
one aspect our ultimate goal is to empower
businesses to reach their full potential globally.
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Contact Us

• https//mavenprofserv.com/medical-devices-registra
  tion- in-bangladesh/
• business_at_mavenprofserv.com enquiry_at_mavenprofserv.
  com