1.
a) Applicant A person who intends to place on the Zambian market a non in-vitro medical devices for human use shall apply to the authority as provided in these guidelines. An applicant who is not resident in Zambia shall appoint a local responsible person with power of attorney who shall be responsible for compliance to regulatory requirements with respect to non in-vitro medical devices. An applicant shall be responsible for the product information in support of the application for Marketing Authorisation and variations thereof. b) Product application An applicant shall submit an application as provided in these guidelines that shall be accompanied by a product dossier that is presented in an electronic text selectable/editable PDF, submitted via the Authority’s online portal. Where an application has product variants such as size, design, dimensions or capacity, the variants shall be considered as different products and shall require separate applications as determined by the Authority. c) Requirements for an application An Application shall comprise the following: (i) Cover letter from the applicant; (ii) A duly completed and signed application form set out in Annex 1; (iii) Proof of payment of the prescribed application fee; (iv) At least two samples of the non in-vitro medical device packaged in the smallest commercial pack size, and labelled primarily in English; (v) A duly completed checklist as set out in Annex 2 indicating the sections of the application that have been completed and the pages thereof; and (vi) Product dossier. An incomplete application for grant of marketing authorisation for a non in-vitro medical device shall not be accepted where one of the documents listed from (i) to (vi) is not attached to the application. d) Documentation To facilitate the review of information submitted, an applicant shall take into consideration the following when submitting the application: e) Language Applications and supporting documents shall be in English. f) Text formatting and layout Information shall be presented in legible letters of 12 font size in Times New Roman or Arial font type of 1.5 line spacing and standard margin. Each page shall be numbered sequentially. Extension sheets, tables, diagrams and other supporting documents shall as far as possible be of the same size, well annotated, numbered and appropriately cross-referenced. g) Payment of Application fees An application for grant of Marketing Authorisation for a non in-vitro medical device shall be accompanied by proof of payment of the fee set out in the Medicines and Allied Substance (Fees) Regulations, 2016. Bank charges in relation to the application shall be borne by the applicant who shall ensure that proof of payment is submitted to the Authority. Marketing Authorisation fees for non in-vitro medical devices shall cover the costs of evaluating the initial submission only and exclude laboratory testing and site audit fees which shall be charged separately. h) Processing of received applications (i) Where deficiencies are identified during screening of an application, a request for additional information shall be made to the applicant. (ii) Subject to (i), an applicant shall be required to submit all the requested additional information within the period specified by the Authority but not exceeding 60 days from the date of receipt of the request. (iii) Where an applicant does not respond to the Authority’s request for additional information within the period stated in (ii), the application shall be rejected. (iv) Where an applicant fails to provide all the requested information, or the submitted information is incomplete, deficient or immaterial, the application shall be rejected. (v) Where the application has been rejected in line with clauses (iii) and (iv), an applicant shall be informed in writing. i) Evaluation of applications for grant of Marketing Authorisation An application shall be evaluated on a first come first serve basis unless expedited evaluation has been authorised by the Authority. j) Quality analysis Where necessary, samples of the non in-vitro medical device may be analyzed by the National Drug Quality Control Laboratory (NDQCL) against the claimed manufacturer’s specifications in accordance with the current available local Standards or other quality specifications such as those prescribed by International Organisation for Standardisation (ISO) and any other internationally recognised standards. k) Site Audit for Compliance to ISO 13485 of The Manufacturing Facility (i) An applicant shall be required to facilitate for site audits of their manufacturing site in order to demonstrate compliance to ISO 13485.The GMP inspection fees set out in the Medicines and Allied Substances (Fees) Regulations, 2016 shall apply in relation to a site audit. (ii) The Authority may in determining whether to conduct a site audit of a manufacturing site referred to in (i) consider: (a) previous satisfactory site audit outcomes conducted by well-resourced or regional regulatory agencies; and (b) that the audit in (ii) was conducted within 24 months preceding receipt of the application. (iii) In instances as determined by the Authority, the option to undertake a desk review by the Authority in lieu of a site audit may occur in the following: (a) Where the applicant shows proof of compliance to successful previous site audits conducted by well-resourced or regional regulatory agencies; and (b) The past satisfactory record of the safety, quality and performance of the product on the global and regional market. l) Grant of Marketing Authorisation The Authority shall grant Marketing Authorisation where the product meets the requirements of quality, safety and performance and any other requirements as set out in the Regulations and these Guidelines. The Marketing Authorisation once granted shall be valid for a period of five (5) years. m) Appeals An applicant who may be aggrieved by a decision made by the Authority in relation to their application for the grant of marketing authorisation may seek redress in accordance with the provisions of the Act. n) Application for Amendment to Marketing Authorisation for a Non IVD Medical Device A Marketing Authorisation Holder (MAH) who intends to effect any change(s) to the device shall inform the Authority of such intended change(s) by means of an application for amendment, which shall be accompanied by relevant supporting documentation and proof of payment of the fee set out in the Medicines and Allied Substance (Fees) Regulations, 2016. Any such change(s) shall require approval by the Authority before implementation. o) Retention fees A Marketing Authorisation Holder (MAH) shall pay the prescribed annual product retention fee for the following year by 31st December of each year. Where the MAH fails to pay the annual retention fee by 31st December: (a) the Authority shall not authorise the importation of the non in-vitro medical device; (b) in case of a locally manufactured non in-vitro medical device, the Authority shall not authorise the continued manufacture of the product; (c) the Marketing Authorisation issued shall be suspended; and (d) the Marketing Authorisation may be revoked by the Authority. p) Vigilance A MAH shall put in place a vigilance system to monitor the quality, safety and performance of a non in-vitro medical devices placed on the Zambian market. The MAH shall ensure that modalities to provide routine reports to the Authority on any findings regarding the product are in place. q) Renewal of a Marketing Authorisation A MAH who intends to renew a Marketing Authorisation shall apply to the Authority on payment of the fee set out in the Medicines and Allied Substance (Fees) Regulations, 2016 at least one hundred and eighty (180) days before the expiry date of the Marketing Authorisation.