Botswana - Registration of Medical Device or In-Vitro Devices (IVDs)

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Procedure

Any establishment that manufactures, imports or distributes of a Medical Device or In-Vitro Devices (IVDs) in Botswna, shall register with the Botswana Medicines Regulatory Authority (BoMRA) Office. BoMRA Office Location & Contact Details

Apply Online:
Step 1: Apply for a Registeration of the Medical Device or In-Vitro Devices (IVDs) with the BoMRA;

1. An application for registration of medical device establishments shall be made through the BoMRA online licensing system.
2. Using a brower type in the BoMRA Website, hover the cursor over the e-service option, then select “Register Medical Decice” under “Register”
3. This will cause the Register Medical Device online page to be displayed, applicant should legiable complete the online registration form accurately, such information that the applicant will be required to furnish the Authority with include;
   • Applicant Details
   • Authorized respesentive details
   • Details of the product (medical device)
   • Attchment of the supporting documentation
   • Paymet of all applicable fees
4. Before submitting the completed registration request form , applicant should double check all information and documentation provided are as required before submitting the request for considerationand processing.

Step 2: Assessment and processing of the application.

1. The Board shall review the application and perform a desk review of the quality manual and the establishment procedures and processes. In evaluating an application for registration of a medical device’s establishment, the Board will consider the supporting documentation provided and information therein including evidence of availability and implementation of at least the following:
   • Quality management system addressing all aspects of quality assurance covering: contracts (agreements); purchasing; manufacturing; final product handling; storage; facility installation; servicing; cleanliness; documentation controls and records; international regulatory control; internal and external audits; training; complaints handling; emergency plan and recalls; quality assurance; management review; distribution (transport, delivery, temperature control); and export documentation (proof of export);
   • Written formal agreement in case any of the activities are delegated to a competent third party.
   • list of all medical devices imported into Kenya product codes, product description, brand name and group/family name, as applicable;
   • For a medium-to-high-risk (Class C) or high-risk (Class D) medical device, proof of pre-market approval or registration of the device from at least one of the member regulatory authorities of the International Medical Device Regulators Forum or confirmation of WHO prequalification; such pre-market approval(s) or registration(s) submitted with an application will be referred to as the “originating approval(s)”
   • For a low-to-medium-risk (Class B), medium-to-high-risk (Class C) or high-risk (Class D) medical device, certificate of free sale from country of manufacture or final assembly; the certificate of free sale is evidence that the medical devices are legally sold or distributed in the open market, freely and without restriction, and are approved by the regulatory authorities in the country of origin
   • For a medium-to-high-risk (Class C) or high-risk (Class D) medical device, the holder of the medical devices establishment registration certificate must be able to provide full technical documentation on the request of the Board
   • where relevant, certificate of conformance/analysis The Board will conduct onsite inspection to assess implementation of the quality management system requirements.

Step 3: Considartion and Issue of the Registration Certificate.

1. Upon confirmation of fulfilment of the requirements the Board shall issue a registration certificate for the medical device’s establishment in the prescribed format.
2. Notice of the decision (Approval, Deferral, or Rejection) for the application will be communicated to the applicant by phone or mail.
3. Registration certificates issued either physciall or through registered mail and shall bear all official markings.
4. In any case where the Board does not recommend the issuing of a medical device’s registration certificate, it shall notify the applicant in writing of the reasons for not recommending/refusing the registration of the establishment; and give the applicant an opportunity to respond to the Board and provide relevant documentation/evidence in support of the application.
5. A medical devices establishment registration certificate shall expire on 31st December each year and it is renewable annually. The registration certificate for manufacturers will be valid for five years following a successful reinspection

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Required Documents

• Accurately completed online form – Register a medical device.
• Copy of the quality manual
• Quality management system in place
• Attestation by an Official Correspondent of the establishment that the establishment has documented procedures in place with respect to: complaints handling, including field safety corrective action; handling of substandard and falsified products; disposal; and any other procedure as required by quality management systems;
• An attestation by an Authorized Representative or responsible establishment official that the establishment has documented procedures in place, where applicable, for handling, storage, delivery, installation, corrective action and servicing in respect of the devices.
• Electronic copy of the establishment quality management system manual and establishment procedures and processes;
• Copy of practice/certificate of registration of the Official Correspondent;
• Copy of items required for national registration of companies, such as a business licence;
• Business registration certificate or certificate of incorporation from the Registrar of Companies
• List of all medical devices imported into Kenya product codes, product description, brand name and group/family name, as applicable
• Evidence of payment of prescribed fees.

Note: The BoMRA Registration & Licensing office reserve the right to request additional supporting documentation.

Office Locations & Contacts

Botswana Medicines Regulatory Authority (BoMRA)
Office Address: Plot 112, Gaborone International Finance Park,
Gaborone
Postal Address: Private Bag 2, Gaborone Station, Botswana
Telephone: +267 373 1720
Toll-free no: 0800 600 216
Fax Number: +267 318 6254
Email Address: [email protected]
BoMRA Office Location & Contact Details
BoMRA Website

Ministry of Health & Wellness (MoH)
Physical Address:Ministry of Health & Wellness
Plot 5460924 Amos Street
Government Enclave
Gaborone
Postal Address:Ministry of Health & Wellness
Headquarters
Private Bag 0038
Gaborone
Toll-Free Customer: 0800600740
Inquiries: 3632500/3170585
Emergency Services: 997 Email Address: [email protected]
MoH Office location & Contact Details
MoH Website
Business hours: Monday-Friday from 8:00 am-1:00 pm and 2:00 pm -5:00 pm, closed during Public Holidays.

Eligibility

The following are eligible to register a medical device in Botswana;

• Manufacturers
• Importers
• Exporters
• Person acting as a wholesaler of,

Fees

• Please consult with the BoMBA for the fees schedules.

Validity

• A medical devices establishment registration certificate shall expire on 31st December each year and it is renewable annually. The registration certificate for manufacturers will be valid for five years following a successful reinspection
• Application for renewal of an existing registration certificate/license shall be submitted three (3) months prior to license expiry.

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

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Processing Time

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Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is dkisplayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

Please provide other instructions related to the certificate/documents.
e.g. The state office holds birth records since January 1908.

Required Information

• Applicant details
• Authorized representive in botswan a details
• Manufacture’s of the product details
• Details of the medical device
  • Name of the prouct (common name/generic name)
  • Software version
  • Brand name/trade name
  • Device intended use
  • Instruction of Use (IFU)
  • Device description
  • Device risk classification
• Declaration by the applicant.

Need for the Document

• No company or individual shall manufacture, import or export or distribute any medical device unless he or she is the holder of a registration certificate.

Information which might help

In-vitro diagnostic (IVD):

• Is a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.

Medical device:

• Any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
• Diagnosis, prevention, monitoring, treatment or alleviation of disease
• Diagnosis, monitoring, treatment and alleviation of or compensation for an injury
• Investigation, replacement, modification or support of the anatomy or of a physiological process
• Supporting or sustaining of life
• Control of conception
• Disinfection of medical devices
• Providing information by means of in-vitro examination of specimens derived from the human body

Other uses of the Document/Certificate

Please explain what are other uses for obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

• Guideline on documents of external origin- BOMRA-ER-MD-P04-G06 Iss1 (2) (1)
  

Others

More information which might help people.