1.0.
An application for grant of Marketing Authorisation of In-Vitro Diagnostics (IVDs) for human use shall be made by submitting completed Form 1 and payment of the prescribed fee.
1.1.
The application for grant of Marketing Authorisation of In-Vitro Diagnostics for human use shall be made as set out in Form I by: 1.1.1 A manufacturer or a person who orders/procures the IVD devices for use or sale in Zambia. 1.1.2 A nominee of the applicant, who must submit a copy of the Power of Attorney. 1.1.3 An applicant who is not resident in Zambia shall nominate a Local Responsible person who must submit a copy of the Power of Attorney and shall be responsible for compliance to regulatory requirements with respect to their IVD devices. 1.1.4 Completed Application forms shall be accompanied with: (a) A complete product dossier file, one hard copy and one soft copy for each single IVD device. (b) Evidence of payment of the prescribed fee for marketing authorisation application. (c) Samples of the IVD device and artworks supplied with the intended consumer packaging labelled primarily in English.(Translations should be in English) (d) Checklist indicating that all sections of the application have been completed and the pages thereof.
1.2.
Documentation format
1.2.1.
All applications and supporting documentation shall be in English.
1.2.2.
Organising documents Each section of the dossier is to be marked by use of clearly annotated tabs and the documentation should be filed in accessible files. Lever arch files are not acceptable. Documents can be combined in volumes as long as appropriately named tab identifiers separate them. For example, the Package insert should be separated from the other documents by a tab identifier. Paper size Standard A4 paper should be used for all submissions. Text and tables should be prepared using margins that allow the document to be printed on A4 paper. The left- hand margin should be sufficiently large that information is not obscured through binding. All parts must be bound separately and arranged sequentially in accessible files. Fonts Font sizes for text and tables should be of a style and size that are large enough to be easily legible, even after photocopying or when provided electronically. Arial / Times New Roman 12 point font is preferred for narrative text, but printing in a font size with a legibility equivalent to at least Arial 10 point black on white could be used. The copies, including figures, tables and photos should be clearly legible. Shading and/or coloured filling/background and/or print, e.g. in tables and headers, or across pages, is unacceptable and should be avoided.
1.3.
1.3.1 The application fees applicable to each type of application should be paid as required. An application not accompanied by the appropriate fee will not be accepted.1.3.2 Applicants may remit payment of fees in, telegraphic transfers and/or by direct deposits into the Authority’s account. When a payment is made by direct transfer, all bank charges shall be paid for by the applicant who shall also ensure that proof of payment is submitted to the Authority. 1.3.3 Application fees for grant of Marketing Authorisation for IVD devices cover the costs of evaluating the initial submission and exclude laboratory testing and current Good Manufacturing Practices (cGMP) inspection fees which may be charged separately for site inspection. 1.3.4 A holder of a Marketing Authorisation shall pay such annual retention fees as may be determined from time to time by the Authority.
1.4.
1.4.1 All applications shall be physically delivered to the Authority. 1.4.2 Applications shall be entered into the Authority’s’ record systems upon confirmation of payment of the application fees.
1.5.
1.5.1 All applications shall be screened for completeness by the Authority before being accepted for evaluation to ensure that there are no deficiencies that would delay and hinder the evaluation process *Reference should be made to the New Dossier Submission Checklist. 1.5.2 If any deficiencies are identified during screening, a request for additional information or material shall be made to the applicant. The applicant shall be required to submit all the requested information and material identified in the input request within twenty-one (21) working days from the date of receipt of request. Any deficiencies indicated must be addressed before the application can be accepted for evaluation. If the applicant anticipates difficulty in responding in full or within the specified timeframe, the applicant shall inform the Authority in writing within fourteen (14) working days of receipt of the input request for information/clarification. 1.5.3 Reasons for non-acceptance of applications 1.5.3.1 If the applicant fails to provide the required information, the application shall not be accepted. 1.5.3.2 Applications not submitted in the prescribed format shall not be accepted at the screening stage.
1.6.
1.6.1 Applications shall be evaluated in the order of submission unless expedited evaluation has been authorised by the Authority. 1.6.2 Applications are evaluated against this guideline for completeness, adequacy and acceptability of the Technical Data submitted.
1.7.
Sample IVD devices may be tested by the Authority’s’ National Drug Quality Control Laboratory (NDQCL) or an appropriate laboratory recognised by the Authority. The number of samples required to be tested shall be determined and requested for by the NDQCL. The Laboratory shall generate a test report that shall form part of the evaluation process.
1.8.
1.8.1 The Authority may carry out a GMP inspection of a manufacturing site/facility of IVD devices established on a risk based approach using cGMP guidelines. An inspection fee, separate from Marketing Authorisation application fee shall be payable to the Authority. The Authority shall inspect the manufacturing facility and prepare an inspection report. 1.8.2 Where the Authority cannot conduct a GMP inspection it shall consider previous satisfactory inspection reports of the site/facility conducted by ZAMRA or other recognised competent Authorities, provided that the inspection was conducted within twenty four (24) months preceding receipt of the application.
1.9.
1.9.1 Final evaluations of IVD devices application for Marketing Authorisation report(s) shall be tabled before the Technical Committee for approval. 1.9.2 The Technical Committee shall also determine the conditions of approval of Marketing Authorisation. 1.9.3 If there are unresolved safety or quality issues the Committee shall defer recommendation pending resolution of the issues. Should the applicant fail to provide the required data within 90 days, the Committee shall refuse to approve Marketing Authorisation of the IVD device. 1.9.4 The Committee may reject approval of an application based on the following reasons amongst others: (a) The product contains a substance considered undesirable for use (b) Failed cGMP by the manufacturer (c) Failed laboratory analytical tests (d) When the product Marketing Authorisation is not in the interest of the public as the Authority may determine.
1.10.
Time frames
1.10.1.
All applications shall be evaluated within one hundred and eighty (180) working days from the date of receipt in the order of submission. The applicant shall be requested to provide additional data when required within ninety (90) working days of such a request. Should more time be required to provide additional data, a formal request must be made by the applicant in writing within fourteen days (14) from the receipt of the request and approved by the Authority.
1.10.2.
information Where the applicant fails to submit additional information within the stipulated time, the Authority shall close the application. Should the applicant wish to resubmit the application, the application shall be processed as a new application.
1.11.
The Authority shall grant Marketing Authorisation if it is satisfied - (a) that the product conforms with the Essential Principles of Safety and Performance. (b) with labelling and packaging of the in-vitro diagnostics devices. (c) with the findings of the laboratory analysis where applicable. (d) that the product is manufactured in compliance with requirements of cGMP.
1.11.1.
A Marketing Authorisation shall be valid for five (5) years subject to terms and conditions as may be specified by the Authority. The period of validity is from the date of grant of Marketing Authorisation.
1.11.2.
(a) The Authority may suspend or revoke the Marketing Authorisation of an IVD device and remove it from the IVD device register through a written notice to the Marketing Authorisation holder or agent for any of the following reasons: (i) Non-payment of the prescribed annual retention fee. (ii) An unforeseen high public or personal health risk associated with using the device. (iii) Inaccurate, false or misleading information given by the applicant during the application stage. (iv) Suspension of a conformity assessment certificate. (v) Non-compliance with the terms and conditions under which the Marketing Authorisation was granted. (vi) Any other reason as the Authority may determine.
1.12.
The Authority shall be informed in writing with evidence of any change(s) to an IVD device that has been grant Marketing Authorisation that could may affect its safety or performance. All applications for an amendment to an IVD device with Marketing Authorisation shall be made in writing and shall be accompanied by a prescribed fee.
1.13.
Application for renewal of a Marketing Authorisation shall be made one hundred and eighty days prior to the expiry of Marketing Authorisation. The Applicant shall submit an application with supporting documentation with payment of the prescribed fees as prescribed by the Authority
1.14.
In-Vitro diagnostic devices may be classified in a four (4) class system, depending on the level of risk to the public as well as the individual (Table 1). The class shall be determined by the manufacturer using a set of classification rules that takes the following into consideration: (a) The manufacturers intended use and indication for use of the IVD device. (b) Where an IVD device has multiple intended uses as specified by the manufacturer, which place the device into more than one class, then it shall be classified in the higher class. (c) Where more than one of the classification rules applies to the IVD device, it shall be allocated to the highest class indicated. Table 1: General classification system for IVD devices CLASS | RISK LEVEL A | Low Individual Risk and Low Public Health Risk B | Moderate Individual Risk and/or Low Public Health Risk C | High Individual Risk and/or Moderate Public Health Risk D | High Individual Risk and High Public Health Risk *Refer to ZAMRA Guidelines on the Classification of Medical Devices
1.15.
Applicants shall be required to compile the product application in the format as per ZAMRA Guidelines for In-Vitro Diagnostic Medical Device Marketing Authorisation Table of Contents. The applicant shall also include:- (a) Completed application form and Product/IVD device details (b) Summary technical documentation (STED) (Refer to ZAMRA STED) (c) Original documentation or notarized copies of the original documents regarding the issuance of any mark/s of quality (e.g. “CE” Mark) with respect to the respective Notified Body must be included in the submission. (d) Labelling information (Refer to ZAMRA Guidelines on Label and Instructions For Use for Medical Devices)) (e) Essential Principles of Safety and Performance (Refer to ZAMRA Guidelines on Essential Principles of Safety and Performance of Medical Devices) (f) Any additional information that the Authority may require REFERENCES 1. GHTF/SG1/N045:2008: Principles of In-vitro Diagnostic (IVD) Medical Devices Classification 2. GHTF/SG1/N063:2011: Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In-vitro Diagnostic Medical Devices 3. GHTF/SG1/N70:2011 Label and Instructions for Use for Medical Devices (revision of GHTF/SG1/N43:2005 Labelling for Medical Devices) 4. GHTF/SG1/N68:2012 Essential Principles of Safety and Performance of Medical Devices (revision of GHTF/SG1/N41:2005 Essential Principles of Safety and Performance of Medical Devices) 5. IMDRF/RPS WG/N13 FINAL: 2014 In-vitro Diagnostic Medical Device Market Authorisation Table of Contents
ANNEX I: Application form
Form I for Human Use) Guidelines, 2018 DEVICES FOR HUMAN USE IN ZAMBIA | For Official Use | | Date Application number | The Guidelines on grant of Marketing Authorisation of an In-vitro diagnostic device to be consulted in completing this form and preparing of dossiers for submission to ZAMRA PART I: PARTICULARS OF THE APPLICANT Applicant name and address | Name: Physical and Postal Address: Phone: Fax: Email: Contact Person1 | Name: Designation: Phone: Fax: Email: Local Responsible Person2 | Name: Designation: Phone: Fax: Email: 1 Contact person will be responsible for communicating with the Authority and a letter of Authorisation to communicate on behalf of the applicant should be submitted. 2 Should be a person, resident in Zambia, appointed by a foreign-based applicant to be responsible for all regulatory matters in respect of products granted marketing authorisation with Power of Attorney or a letter of acting as an agent. PART II: PARTICULARS OF THE IVD DEVICE Manufacturers name and | Name: Physical and Postal Address: Phone: Fax: Email: address | Number of samples IVD devices | submitted | Generic name of the IVD device | (Where applicable) | Brand name of the IVD device | Model/Series/System of the IVD | device (Where applicable) | GMDN description of the IVD | device | Short description if none of the | GMDN descriptions seem | appropriate | GMDN code of the IVD device (if | known) | Intended use of the IVD device | IVD device Classification | Class A Class B Class C Class D Have there been any of the | Previous recalls Reportable adverse incidents Banning in other countries Post-market surveillance studies following: | Please provide details on each item | ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________________________ ______________________________________ you have ticked (attach any | relevant documentation) | International or national | standards with which the IVD | device complies (enclose a copy) | List the SADC states where the | IVD device has obtained | marketing approval (Attach | documentation) | PART III: DECLARATION AND SIGNATURE I declare that all the information I have stated is correct and truthful to the best of my knowledge and belief. Particulars of the Person Signing on Behalf of the Applicant a) Name: …………………………………………………………………………………………. b) Designation: ………………………………………………………………………………….. c) Signature: ………………………… d) Date: …/…/……….(dd/mm/yyyy)