Medical Devices. BARBADOS Clarke Gittens Farmer

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Medical Devices BARBADOS Clarke Gittens Farmer CONTACT INFORMATION Danielle Maycock Clarke Gittens Farmer Parker House, Wildey Business Park Wildey Road, St. Michael, Barbados Tel. 246.436.

1 Medical Devices BARBADOS Clarke Gittens Farmer CONTACT INFORMATION Danielle Maycock Clarke Gittens Farmer Parker House, Wildey Business Park Wildey Road, St. Michael, Barbados Tel Definition of medical devices What is the definition of a medical device in your jurisdiction? There is no specific definition of medical device but Regulation 2 of the Health Services (Control of Drugs) Regulations, 1970 defines the word device as follows: device means any instrument, apparatus or contrivance including components, parts or accessories thereof manufactured, sold or represented for the use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state or the symptoms thereof in man or animal 2. Combination products i. Which legal regime (on medicinal product or on medical devices) applies to combination products incorporating both medicinal products (drugs/biologics) and medical devices? Although the Health Services (Control of Drugs) Regulations, 1970, refers to drugs and devices, most of the regulations refer to drugs. Presumably, to the extent that it incorporates dugs, a combination product would be subject to the same regime as drugs.

2 The Drug Control Advisory Committee established under the Health Services Act, Cap. 44, advises the Minister of Health on matters relating to the manufacture and production of drugs in Barbados. Such drugs must comply with standards contained in publications specified in the Second Schedule to the Regulations. ii. Are combination products (combining drugs and medical devices) subject to separate regulation in your jurisdiction? No. iii. If the answer to (i) is negative, what is the scope of application of the legal regimes: evaluating both the drug and device components of the combination product? Manufacture or production of drugs requires a license and is subject to supervision, analysis and labeling requirements. There is provision for inspection, seizure and analysis of articles to which the Regulations relates. iv. What are the general conditions for review, approval and marketing the combination product? Regulation 8 of the Health Services (Control of Dugs) Regulations, 1970 provides for the following: a. No person shall manufacture or produce for sale any drug unless he is licensed to do so, the process is under the supervision of a pharmacist, each batch is subjected to analysis and assay as determined by the Chief Medical Officer, and each container is labeled as prescribed. b. A drug manufactured or produced in Barbados may not be sold it confirms to one of the standards specified in the Second Schedule to the Regulations; it has been analysed and approved by the Chief Medical Officer. Regulation 6 proscribes the sale and advertising of any drug or device in a manner that is false, misleading or deceptive, or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. The importation, manufacture, sale or dispensation of certain listed drugs is prohibited except with the licence of the Minister of Health (Regulation 10 and Fourth Schedule) Samples of drugs or devices may only be made to medical practitioners, dentists, veterinary surgeons or pharmacists. (Regulation 11) A drug which is legally saleable for consumption in another country may be imported to Barbados if that drug wholly complies with the law of the country in which it was manufactured or produced. The onus is on the importer to prove such compliance (Regulation 12) The Regulations provide for inspection, seizure, analysis and destruction of drugs and articles (Regulations 13 14)

3 3. Borderline products Are there any official and binding criteria for determination whether the product is a medicinal product or medical device, or whether a product is a device requiring pre-review or a non-medical device? i. Are there any legal and binding criteria for determination whether the product is a medical device or medicinal product? There are no legal and binding criteria for determination as to whether the product is a medical device or medicinal product. ii. If the answer to (i) is positive, what are the main principles for differentiation? Not Applicable. iii. Are there any significant court or administrative judgments demonstrating the rules of product differentiation? iv. How is software that may have some related-medical applications regulated in your jurisdiction? Software of this type is not specifically regulated in Barbados. However, such software may fall within the definition of device and would be subject to the Regulations referred to above. 4. Cellular or tissue based products Are there any official or binding criteria for determination whether a product is a animal or human based tissue or a medical device? i. How are products composed of cells or animal/human tissue regulated in your jurisdiction? Regulations 18 and 23 of the Animals (Diseases and Importation Control) Regulations, 1961 state as follows: Regulation 18 No animal products, including hides, skins, horns, hair, wool, bones, bone meal, meat scrap and tankage, shall be imported into the Island except in accordance with the terms of a permit granted by the Senior Veterinary Officer and subject to such conditions as he may therein impose Regulation 23 (1) No biological product prepared from animal tissues intended for use in veterinary medicine shall be imported into the Island except in accordance with the terms of a permit granted by the Senior Veterinary Officer.

4 (2) In this regulation, biological product includes any substance commonly known as hormones, vaccines, sera, toxins, anti-toxins and antigens intended for use in the practice of veterinary medicine. ii. Are there any legal and binding criteria for determination whether the product is a medical device or cellular/tissue based product? There are no legal or binding criteria for determination whether the product is a medical device or a cellular/tissue based product. iii. If the answer to (ii) is positive, what are the main principles for differentiation? Not applicable. iv. Are there any significant court or administrative judgments demonstrating the rules of product differentiation? We are not aware of any significant court or administrative judgments which demonstrate the rules of product differentiation in this context. 5. Admission to trade of medical devices What are the requirements for admission (import) of medical devices into trade? i. Is clinical assessment required for admitting (importing) medical devices into trade? Yes, clinical assessment is required. Refer to 2(iv) above. ii. If the answer to (i) is positive, are clinical trials required or is there an alternative basis for clinical assessment? In order to import medical devices into Barbados, all clinical trials on the devices must have been done prior to importation and must be done to the standards of the International Organization for Standardization. iii. Is certification by an external certifying body required for compliance assessment of medical devices, or is a manufacturer s declaration of conformity sufficient? A drug (which definition may include a medical device involving a drug) which is legally saleable for consumption in another country may be imported to Barbados if that drug wholly complies with the law of the country in which it was manufactured or produced. The onus is on the importer to prove such compliance (Regulation 12) iv. Is administrative pre-clearance or pre-approval of medical devices required for admission of medical devices into trade, or is post-launch notification sufficient? There are no specific regulations on this point.

5 6. Processing of personal data (privacy) What are the rules of processing of personal data in a number of activities performed by manufacturer/s distributors/ healthcare units with the use of medical devices. i. Are there any specific rules protecting the privacy of personal data of consumers purchasing medical devices, by manufacturer/distributors? No, there are no specific rules to be followed by manufacturers/distributors which protect the privacy of personal data of consumers who purchase medical devices. ii. Are there any specific rules of processing of personal data sourced by means of medical devices containing software, by healthcare units? No, there are no specific rules of processing of personal data which has been sourced by means of medical devices containing software by healthcare units. iii. Are there any specific rules of processing of personal data by manufacturers/distributors in case of collecting reports on medical incidents from customers? Not that we are aware of. iv. What is the standard for reporting adverse events, and is reporting of events in foreign countries required, and using what standards? The standards used are those stipulated by the International Organization for Standardization. 7. Reimbursement What is the optimal model of reimbursement of medical devices? i. What are the rules of granting reimbursement of medical devices in your jurisdiction? 8. Distribution Is distribution and promotion of medical devices subject to legal regulation? i. Are there any specific regulations determining mode of business activity of medical devices distributors? This type of business activity is governed by the Health Services (Control of Drugs) Regulations, ii. Is administrative permit for medical devices distribution required? If the medical device includes a drug, the importation, sale or manufacture of the device will be subject to the rules discussed at 2 above. Otherwise, no administrative permit is required.

6 iii. Are there any specific limitations in distributing medical devices in your jurisdiction? Pursuant to Regulation 11 of the Health Services (Control of Drugs) Regulations, 1970: No person shall distribute or cause to be distributed any device as a sample except to a medical practitioner, dentist, veterinary surgeon or druggist. However, there are no other limitations to the distribution of medical devices except as outlined above. iv. Are obligations of distributors of medical devices specifically legally regulated? Save as provided for in the general laws governing fair trading and liability at common law in tort, the obligations of distributors of medical devices are not specifically legally regulated. v. What specific rules exist for advertising and promoting medical devices? Regulations 4 and 6 of the Health Services (Control of Drugs) Regulations, 1970 provide the following: 4. No person shall - (a) advertise any device for the treatment, prevention or cure of any of the diseases mentioned in the First Schedule; or 6. No person shall advertise any device in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. 9. Manufacturing How are manufacturing practices regulated? i. Are there any specific standards or regulations determining the quality of manufacturing practices? To the extent that a medical device could include a drug, the manufacture of a device would be governed by the Health Services (Control of Drugs) Regulations, 1970, discussed at 2 above. Otherwise, there are no specific national standards or regulations which determine the quality of manufacturing practices for medical devices. Barbados conforms to the standards which are set out by the International Organization for Standardization.

7 ii. If the answer to (i) is positive, how are these good manufacturing practices or quality system regulations reviewed and enforced? Subject to the comments above, Regulation 8 of the Health Services (Control of Drugs) Regulations, 1970, gives power to the Chief Medical Officer to license, inspect, analyse, seize and destroy articles connected with the manufacture of drugs. iii. Are establishments manufacturing medical devices, or components of medical devices, required to be registered with a government regulator? If such device or component includes drugs, the manufacturer or producer requires to be licensed. See 2. above. iv. Are these establishments inspected regularly by government regulators or authorized bodies, and what is the mode of such inspections? To the best of our information, there are presently no undertakings manufacturing medical devices or components of medical devices in Barbados. 10. Regulatory Guidance How are the requirements communicated to medical device manufacturers? i. In what form do the laws and regulations appear that are applicable to medical device manufacturers? The laws and regulations are publicly available for purchase at the Barbados Government Printery and on the internet. ii. Are informal guidance or the opinions of regulators available to device makers, and in what form? Unknown.

Medical Devices. UKRAINE Magisters

Medical Devices. UKRAINE Magisters Medical Devices UKRAINE Magisters CONTACT INFORMATION Oleg Boichuk, Senior Associate Oleksandr Liulkov, Associate Magisters 38 Volodymyrska St., Kyiv, Ukraine +38044 492 82 82 www.magisters.com 1. Definition