GUIDELINES FOR MEDICAL DEVICES REGISTRATION

Transcription

1 GUIDELINES FOR MEDICAL DEVICES REGISTRATION

2 FOREWORD The purpose of Drug Registration is to ensure that a pharmaceutical product has been adequately tested and evaluated for safety, efficacy and quality, and that the product information provided by the manufacturer is accurate. It also allows the pharmaceutical product to be placed on the market until the registration period for the product has expired. The Pharmacy Board of Sierra Leone has developed and adopted the following guidelines on: I) Guidelines for the registration of Medical Devices. These guidelines are intended to facilitate the registration process of Medical Devices, and are meant to be adopted and implemented by all stakeholders intending to market Medical Devices in Sierra Leone. The overall goal of these guidelines is to achieve the highest practicable standards of the quality of products imported into Sierra Leone and in addition to ensure the safety, quality and efficacy for these products( medical devices) manufactured, imported, exported and distributed to ensure the protection of the public health as envisaged by the Pharmacy and Drugs Act. It should be noted however, that these guidelines are subject to review as and when necessary by the Pharmacy Board of Sierra Leone.

3 PHARMACY BOARD OF SIERRA LEONE GUIDELINES FOR THE REGISTRATION OF MEDICAL DEVICES. 1. SCOPE In pursuance of Section 55 of the Pharmacy and Drugs Act, these Guidelines are hereby made to provide guidance to applicants on the procedure and requirements for the registration of chemical substances. 1.1 INTERPRETATION 1.2 DEFINITIONS OF TERMS In these Guidelines, unless the context otherwise requires, Board Means Pharmacy Board of Sierra Leone Product means any article that is regulated under the Pharmacy and Drugs Act,2001, which includes drugs, cosmetics, medical device and household chemical substances or any articles that are used in the manufacture of these. Non-compliant product includes unregistered, counterfeit, substandard and any other product that shall be determined by the Board. banned product, restricted product etc. Approved port means Freetown International Airport, Lungi Queen Elizabeth II Quay and any other sea, air or land borders, as may be approved by the Board from time to time. MEDICAL DEVICE IS DEFINED AS FOLLOWS: Medical Device means any instrument, apparatus including components, parts and accessories of it, or medical consumables manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms of it in man or animal. A medical device can be: (a) Condom (b) Glove (Surgical/Examination) (c) Test -Kit. (d) Needle and syringe (e) Insecticide Treated Net (ITN) etc.

4 For every batch of goods introduced to Sierra Leone, the importer or local agent (i.e Sierra Leone domestic company) shall apply for an Import Permit. 2. REQUIREMENT FOR MARKET AUTHORIZATION 2.1 REGISTRATION 1. An application for the registration of a medical device shall be made in writing in duplicate to the Board. 2. The application shall be accompanied by, (i) (ii) (iii) a duly signed covering letter sample(s) of the produc(s)t in the final package and completely filled application form as specified in the Boards guidelines. a non- refundable prescribed application fee as specified in the Board s guidelines. 2.2 REGISTRATION VARIATION 3. For a product whose registration is not expired, an application for the re-registration in respect of any variation shall be submitted for approval by the Board before any importation of the product reflecting the variation. 4. The application shall be accompanied by: (i) (ii) (iii) Supporting documents for the variation. Samples reflecting the variation as specified in the Boaed s guidelines. Non-refundable variation fee as specified in Board s guidelines.

5 2.3 RE-REGISTRATION a. An application for the re-registration of a products shall be made 3 (three) months prior to expiration of the previous registration. b. The application shall be accompanied by: (i) (ii) (iii) Documentation for any changes since the product was last registered. These changes shall include, but not be limited to, manufacture, packaging, labeling and site. Samples of the product in the final package as specified in the Boaed s guidelines. Non-refundable application fee as specified in the Board s guidelines. 3. SPECIFIC REQUIREMENTS FOR REGISTRATION OF CONDOMS AND GLOVES 3.1 CONDOMS Packaging of condoms Every condom shall be sealed in an individual pack which shall state thereon the date of manufacture of such condom and the date of expiry. Each package of condoms shall state thereon the name and address of the manufacturer of such condom. Storage of condoms No person who stores for sale any condom shall expose such condom to heat in excess of twenty-eight degrees Celsius, moisture, direct sunlight or fluorescent lighting. Distribution of unapproved batches of condoms prohibited No importer, manufacturer or wholesaler, as the case may be, shall sell any condom unless the batch, of which such condom is a part, has been approved for distribution by the Board. Where the Board approves a batch of condoms, such batch may be sold for such period as determined by the Board.

6 Shelf life of condoms No person shall sell any condom, which is more than thirty-six months old from the date of manufacture. Provided that in the case of a type and brand of condoms whose shelf life exceeds thirty six months the manufacturer concerned shall supply satisfactory stability data on such type and brand of condoms. No person shall import any condom, which has less than six months of its shelf life remaining.

7 Sale of expired condoms prohibited No person shall sell any condom on a date later than the expiry date, which appears on the package of such condom. Notification of change of particulars Every person shall without delay inform the Board of any alteration from the information or particulars furnished by him in applying for approval for a type and brand of condom. Withdrawal of condoms Where the Board is of the opinion that the withdrawal of any batch of condoms is necessary for the protection of the public, the Board may require any person to withdraw such batch of condoms in accordance with the procedure as determined by the Board. 3.2 GLOVES SPECIFICATIONS Gloves are classified into two types; Type 1- Gloves compounded primarily from natural rubber latex. Type 2 Gloves compounded from rubber cement or synthetic rubber. To facilitate donning of the gloves, surface treatment, lubricant or powder may be used. These must have the following requirements:- Any pigment used shall be free from hazardous substances. Any lubricant must meet the current requirements of the U.S Pharmacopoeia for absorbable dusting powder to be applied to gloves. Other lubricants may be used if their safety and efficacy have been previously established. DESIGN The glove shall be anatomically correct, with the thumb positioned towards the palmar surface of the index finger rather than lying flat. The fingers and the thumb may be straight or curved in the palmar direction. The cuff shall fit closely without being constrictive. It shall not roll back or ruck whilst in use.

8 SHELF LIFE Expiry date- Gloves shall comply with the performance requirements of this specification throughout the stated shelf life of the gloves. The shelf life stated by manufacturer shall not exceed 5 years. The Board reserves the right to extend the shelf life of all rubber gloves provided appropriate tests are done to justify the extension. STORAGE The gloves shall be stored appropriately such that their quality is not compromised. Storage temperature shall not exceed 40 o C. The storage warehouse shall be free from moisture and direct sunlight. Height of the stacked cartoons shall not significantly affect free circulation of air. Good manufacturing practices should always be observed when handling gloves throughout the whole distribution chain. PERFOMANCE REQUIREMENTS All dimensions, samplings and testing for sterility shall be conducted in accordance with the Board s current or latest edition of regulatory standards of the National Pharmaceutical Quality Control Laboratory

9 4. GENERAL REQUIREMENTS (1) a. The presentation of the product shall not have any resemblance in spelling, brand pronunciation of name and packaging to another product previously registered by the Board. a. Samples submitted for registration shall be in the final package proposed for marketing of the product in Sierra Leone. b. If a product is manufactured on contract, evidence of the contract shall be produced in the documentation submitted. This shall be clearly stated on the label of the product. c. All documentation submitted shall be in English, and must be legibly printed and not hand written. d. All samples of products submitted shall conform to current labeling regulations. e. For locally manufactured products, the original certificate of analysis issued by a recognized public analyst shall be submitted. f. For imported products, an appropriate certificate of analysis of the finished product shall be submitted. g. Supporting evidence shall be submitted for any special labeling claims. (2) The Board in considering an application: h. May ask the applicant to supply such other information as may be required to enable it reach a decision on the application. i. Shall satisfy it that there is need to have the product registered in Sierra Leone. j. May consult other bodies and experts with knowledge of the product. (3) A form submitted for the registration of a product under these regulations shall have attached thereof:- i. Samples of the product as may be prescribed. ii. For a locally manufactured product, the original certificate of analysis of the product, where applicable may be required. (4) Any person given the power shall be required to satisfy the Board that he has the resources and facility to exercise an effective recall of the product if the need arises.

10 (5) Where the Board is satisfied that there is the need to register the product, it shall do so and issue to the applicant a certificate of registration, subject to such conditions as may be deemed necessary. (6) The registration of a product under these regulations, unless otherwise revoked, shall be valid for a period of 1(one) year and 3 (three) years for subsequent applications. (7) The Board shall from time to time, publish a notice in the Gazette notifying the registration of product under these regulations. (8) No person shall disclose any information supplied to the Board in pursuance of section 2 of these regulations except: i. With the written consent of the person who supplies the information; or ii. In accordance with the directive of the Board; or iii For the purpose of a legal process under the Pharmacy and Drugs Act, (9) The Board may cancel the registration of a product if:- i. The grounds on which the product was registered is later found to be false or incomplete; or ii. The circumstance under which the product was registered has been contravened; or iii. Any of the provisions under which the product was registered has been contravened; or (iv) The standard of quality, safety and efficacy, as prescribed in the documentation for registration is not being complied with; or (b) The premises in which the product or part thereof is manufactured assembled or stored by or on behalf of the holder of the certificate of registration are unsuitable for the manufacture, assembling or storage of the product. 5. SANCTIONS AND PENALTIES 6.1 Non-Compliant Products 1. The Board may apply the following in case of the importation of a non-compliant product after detention and issuance of appropriate detention notice: (a) Order the re-export of the product at the cost of the importer. (b) Where the registration of a product is suspended or cancelled, the Board shall cause the withdrawal from circulation of that product and shall accordingly cause the suspension, cancellation or withdrawal to be published in the Gazette. The Confiscate non-compliant product, may be destroyed and the cost of destruction borne by the importer, who may be prosecuted accordingly.

11 (c) An appeal for review of an application can be made in writing not later than 21 days to the Registrar and this shall be accompanied with an appropriate fee. 6.2 Bringing Into Compliance 2. The Board may permit an importer to bring an imported non-compliant product into compliance with the law. Any sorting, processing, labeling/ re-labeling or analysis shall be supervised by an officer of the Board at the expense of the importer. 3. Where the non-compliant product is unregistered, the importer shall be made to submit the product for registration and pay the appropriate fees in addition to a penalty to be determined by the Board.