Article 11: Assessment process of Medical Devices and In Vitro Diagnostics

• The Authority shall, upon being satisfied by the completeness of the application, conduct assessment to verify the compliance with safety, quality and performance requirements through full or abridged assessment procedures.
• The Authority shall set out guidelines, sops (to recheck), forms, and tools for full and abridged assessment procedures.
• The authority may, during the assessment of the device, request the applicant to submit additional samples, documents, information, data or clarification to support the application for registration.
• Where the Authority requires the information stated above, the processing of the application shall not proceed untilthe applicant provides the required additional information.
• Where the applicant fails to submit the requested information, within the period of ninety (90) days from the date of request, the application shall be considered withdrawn.
• The applicant may by giving reasons in writing request for an extension of time for submission of additional samples, documents, information, data and or clarification requested by the Authority.
• If the applicant fails to provide satisfactory responses to the requested informationfor a fourth time, the application shall be rejected.

1. DEVICE DESCRIPTION

2. MEDICAL DEVICE SPECIFICATION
 2.1 Label
 2.2 Design and Manufacturing Information

3. DEVICE DESIGN AND MANUFACTURING
 3.1 Device Design
 3.2 Manufacturing Processes
 3.3 Design and Manufacturing Sites

4. ESSENTIAL PRINCIPLES AND RISK MANAGEMENT
 4.1 Essential Principles (EP) Checklist
 4.2 Risk Analysis and Control

5. PRODUCT VERIFICATION AND VALIDATION
 5.1 General
 5.2 Biocompatibility
 5.3 Medicinal Substances
 5.4 Biological Safety
 5.5 Sterilization
 5.6 Software Verification and Validation
 5.7 Animal Studies
 5.8 Clinical Evidence

6. DECLARATION OF CONFORMITY

A complete label associated with the device should be submitted. The labelling information shall include the following:
o the name of the device, both “proprietary” and “common”.
o the name and address of the manufacturer
o the manufacturing site address
o the identifier of the medical device (serial number or batch number) that is part of a system, test kit, medical device group, medical device family or medical device group family
o the control number, otherwise the batch or lot number in the case of Class C & D
o an indication of what the package contains, expressed in terms appropriate to the medical device, such as size, net weight, length, volume or number of units
o the word “Sterile” if the manufacturer intends to sell the medical device in a sterile condition
o the words “For single use only” if the medical device is intended for that purpose, the expiry date of the medical device expressed in day, month and year.
o unless self-evident to the intended user, the medical conditions, purpose and uses for which the medical device is manufactured, sold or represented, including the performance specifications of the medical devices if those specifications are necessary for proper use;
o the directions for use; unless directions are not required for the safe and effective use of the device
o warnings, precautions and limitations of the device.
o The labelling design shall not bear close resemblance to other devices already registered by the Authority
o where a package that contains a device is too small to display all the information as specified in above, the directions for use shall accompany the device but need not be set out on the outside of the package or be visible under normal conditions of sale.
o Promotional material (brochures, catalogues and others)

Regulations Governing the Conduct and Inspection of Clinical Trials in Rwanda

Refer Page 23

The manufacturer attests that its medical device complies fully with all applicable Essential Principles for Safety and Performance and draws up a written „Declaration of Conformity‟. As a minimum, this declaration should contain the following information:
o An attestation that each device that is subject to the declaration complies with the applicable Essential Principles for Safety and Performance, 
o Information sufficient to identify the device (s) to which the Declaration of Conformity applies.
o The Global Medical Device Nomenclature (GMDN) code and term for the device.
o The risk class allocated to the device(s) after following the guidance found in Initial Classification rules.
o Which of the conformity assessment elements described in Section 5 have been applied.
o The date from which the Declaration of Conformity is valid.
o The name and address of the device manufacturer.
o The name, position and signature of the responsible person who has been authorised to complete the Declaration of Conformity upon the manufacturer‟s behalf

Guidelines on Safety and Vigilance of Medical Products and Health Technologies

 It is important to report the following:
 a. All serious adverse events/reactions related to the medical products and health technologies.
 b. All local expected and/or unexpected suspected adverse reactions and events to medicinal products, traditional/alternative/herbal medicines, biologicals, vaccines, x-ray contrast media, medical devices, diagnostics and cosmetics,
 c. All Adverse Events Following Immunization (AEFI)
 d. All medication errors,
 e. All suspected AEs that may be associated with suspected or confirmed quality defects including substandard and/or falsified medical products,
 f. Case reports of acute and chronic poisoning (toxicity),
 g. Abuse, overdose, misuse and off label use of medical products,
 h. Adverse interactions of medicines with chemicals, other medicines and food supplements,
 i. Lack of therapeutic efficacy/therapeutic failure,
 j. Any AEs observed in pregnancy or during breastfeeding,
 k. All SAEs and SUSARs on exposure to investigational products,
 l. Other patient or community safety concerns about medical products,
 m. All suspected poor-quality medical products
 n. Adverse events resulting from products used during phase IV clinical studies.
 o. Periodic Safety Update Report (PSUR)/ Periodic Benefit/Risk Evaluation Report (PBRER)/ Development Safety Update Report (DSUR).

Healthcare Professionals and/or Patients

Serious or Fatal Adverse Events/Adverse Drug Reactions (AE/ADR): Must be notified within 24 hours. A complete report must be submitted within seven (7) calendar days.

On identifying a significant increase or trend of events or incidents that are usually excluded from individual reporting, the manufacturer or the MAH must report to the Authority. The manufacturer should have suitable systems in place for proactive scrutiny of trends in complaints and incidents occurring with their devices. Field Safety Notices (FSN) and Field Safety Corrective Actions (FSCA) including those based on incidents occurring outside Rwanda must be reported to Rwanda FDA.

The maximum time for recalling class I, II and III shall be three (3) working days, ten (10) working days and thirty (30) working days, respectively and Class I is for defective, dangerous or potentially life threatening unfit regulated products that predictably or probably could result into serious health risk or adverse events or death.

Regulations Governing Promotion, Advertisement and Marketing of Regulated Products

The validity of registration certificate is 5 years.