WEBVTT Kind: captions Language: en 00:00:06.970 --> 00:00:17.900 Friends, again welcome to Regulatory Requirement for Medical Devices and In Vitro Diagnostics 00:00:17.900 --> 00:00:26.079 in India lecture 4 that is Type of Medical Devices including combination devices. In 00:00:26.079 --> 00:00:34.360 this lecture before we further continue I want to brief you. In the previous lecture 00:00:34.360 --> 00:00:40.830 we have discussed what what is the regulation for the medical devices? What type of medical 00:00:40.830 --> 00:00:45.840 devices are under regulation? It is not the all the type of medical devices are presently 00:00:45.840 --> 00:00:52.740 under regulation in India. So, only certain medical devices which falls 00:00:52.740 --> 00:00:58.900 under the definition of section 3 b i, section 3 b ii and section 3 b iv. Section 3 b iv 00:00:58.900 --> 00:01:06.790 that is the notified medical devices and we have also understand how many devices, how 00:01:06.790 --> 00:01:11.170 many categories of the devices. So, far the Ministry of Health and Family Welfare has 00:01:11.170 --> 00:01:17.510 been notified. And what are the new medical devices which have been notified recently 00:01:17.510 --> 00:01:24.080 by the Ministry of Health and Family Welfare. So, we understand how many devices total notified 00:01:24.080 --> 00:01:30.120 to which are under regulation? Also we discussed in detail classification classification of 00:01:30.120 --> 00:01:35.590 the devices. The classification of the devices that criteria has already been in prescribing 00:01:35.590 --> 00:01:42.990 the first schedule of the medical device till in 2017. And in that classification, the classification 00:01:42.990 --> 00:01:49.120 is made based on the intended use of the medical devices as well as the risk associated with 00:01:49.120 --> 00:01:54.119 the medical devices. So, based on the risk and their intended use 00:01:54.119 --> 00:02:02.520 the devices is classified and risk based classification, criteria, parameter have already been given 00:02:02.520 --> 00:02:08.950 based on that the Central Licensing Authority has classified various medical devices under 00:02:08.950 --> 00:02:25.090 the category of regulated medical devices. In general, the medical devices can be active 00:02:25.090 --> 00:02:38.091 or statics. The static devices are the simplest devices having few or no moving parts. Example 00:02:38.091 --> 00:02:52.209 of the static devices are cardiac stent it holds the tree open by virtue of their shape. 00:02:52.209 --> 00:02:58.040 The active devices are more complex. Some active medical devices operates throughout 00:02:58.040 --> 00:03:05.110 the application of human movement or by the effect of the gravity. The example a syringes 00:03:05.110 --> 00:03:12.470 which is a powered by the force applied by the patient or the medical professionals. 00:03:12.470 --> 00:03:25.930 While an in in while an IV drip is powered by the gravity. Other devices can be activated 00:03:25.930 --> 00:03:37.700 by a patient's natural body movements, such as walking or breathing. The active implantable 00:03:37.700 --> 00:03:45.489 medical devices are powered devices that are inserted into the patient's body, through 00:03:45.489 --> 00:03:53.500 either a natural orifice or by surgical means, and are intended to remain in the patient's 00:03:53.500 --> 00:04:04.081 body after the procedure. Such devices usually operated usually poweredby the battery it 00:04:04.081 --> 00:04:12.420 is a battery powered. Example like pacemakers is one of the example for active implantable 00:04:12.420 --> 00:04:19.769 medical devices. Non invasive devices are those devices that 00:04:19.769 --> 00:04:28.180 do not involve a break in the skin. There is no contact with the mucous membrane or 00:04:28.180 --> 00:04:36.520 internal body cavity other than through a natural or artificial body orifice. The example 00:04:36.520 --> 00:04:50.610 of non invasive medical devices are the BP apparatus, CT scan, ECG, MRI etcetera. The 00:04:50.610 --> 00:05:02.310 combination medical devices, combination medical devices is a devices that involve a medical 00:05:02.310 --> 00:05:12.680 devices and or a drugs and or a biologics, combining any two of these product categories, 00:05:12.680 --> 00:05:25.130 and sometimes even all the three. These types of the devices will be consider 00:05:25.130 --> 00:05:33.440 as a combination medical devices. The example of the combination medical devices that is 00:05:33.440 --> 00:05:40.350 one of the example is drug eluting stent, where is a scaffold coated with the drugs 00:05:40.350 --> 00:05:48.320 to prevent the scar tissue from growing in an artery. Although in the medical device 00:05:48.320 --> 00:06:00.380 rule the combination devices have not been clearly defined, but in general the devices 00:06:00.380 --> 00:06:15.170 like drug eluting stent. Wherein the drug is coated with the stent platform, stent platform 00:06:15.170 --> 00:06:24.280 that is meant for stainless steel or cobalt chromium will be example of the combination 00:06:24.280 --> 00:06:33.300 medical devices. In other regulatory systems like USFDA they 00:06:33.300 --> 00:06:42.150 have to define the types of the combination product. And what types of the combination 00:06:42.150 --> 00:06:52.180 devices are there they have categorized. Some of the example like convenience kit or co 00:06:52.180 --> 00:06:58.550 package where in drug and devices are provided as individual constituent part within the 00:06:58.550 --> 00:07:06.680 same package. The prefilled drug delivery devices or system where in drug is filled 00:07:06.680 --> 00:07:14.440 into or otherwise combined with the device and the sole purpose of this device is to 00:07:14.440 --> 00:07:21.910 deliver the drugs. Prefilled drug syringes, transdermal systems 00:07:21.910 --> 00:07:34.940 the example of such devices. The devices coated impregnated otherwise combined with the drugs. 00:07:34.940 --> 00:07:43.090 The device as an additional functions in addition to the delivering the drugs. Example of such 00:07:43.090 --> 00:07:52.520 combination devices are the drug eluting stent, condom with spermicide, antimicrobial coating 00:07:52.520 --> 00:08:03.830 catheters, sutures, bone cements with that antibiotics. The possible combination based 00:08:03.830 --> 00:08:10.090 on cross labelled of separate products. That is dug biological products under development 00:08:10.090 --> 00:08:19.539 utilize a devices, but unclear whether the final product will require that the two be 00:08:19.539 --> 00:08:25.760 cross labelled. Other type of combination products where in 00:08:25.760 --> 00:08:38.130 drug, device and biological product. Combination product or not otherwise describes all the 00:08:38.130 --> 00:08:45.550 three articles are combined in a single product. The example are the prefilled syringes containing 00:08:45.550 --> 00:08:52.730 an antibody drug conjugates So, these are the various types of the combination devices 00:08:52.730 --> 00:09:04.019 though other reliability authority have defined were but in and in the medical device around 00:09:04.019 --> 00:09:13.130 2017 this combination device has not been defined. Although the medical device rule 00:09:13.130 --> 00:09:21.889 2017 includes certain definitions of active diagnostic medical devices, active medical 00:09:21.889 --> 00:09:37.480 devices, active therapeutic medical devices. So, in the definition of the chapter 1 these 00:09:37.480 --> 00:09:41.339 devices has been clearly defined. 00:09:41.339 --> 00:09:50.149 The active diagnostic medical devices define the medical device rule 2017; that means, 00:09:50.149 --> 00:09:58.459 any active medical devices used whether alone or in combination with other medical devices, 00:09:58.459 --> 00:10:05.959 to supply information for detecting, diagnosis or monitoring, or to provide support in the 00:10:05.959 --> 00:10:16.220 treatment of any physiological conditions, state of health, illness or congenital deformity. 00:10:16.220 --> 00:10:25.610 The example in the hepatitis or HIV tests, clinical chemistry, coagulation test systems, 00:10:25.610 --> 00:10:36.279 urine test strip test. Another definition for the active medical devices have been included 00:10:36.279 --> 00:10:43.439 in the medical device rule. Active medical devices means a devices, the 00:10:43.439 --> 00:10:49.989 operation of which depends on the source of electrical energy or any other source of energy 00:10:49.989 --> 00:10:59.540 other than the energy generated by human or animal body or gravity. The example of this 00:10:59.540 --> 00:11:06.649 type of active medical devices are cardiac pacemakers, defibrillators, cochlear implants 00:11:06.649 --> 00:11:14.730 also in the medical device rule 2017. Active therapeutic medical devices has been 00:11:14.730 --> 00:11:22.060 defined which prescribe that. Active therapeutic medical devices means any active medical devices 00:11:22.060 --> 00:11:31.989 used either alone or in combination with any other medical devices to support modify, replace 00:11:31.989 --> 00:11:39.699 or restore biological function or a structure with a view to the treatment or alleviation 00:11:39.699 --> 00:11:51.009 of any illness, injury or handicap. Example of such type of medical devices or 00:11:51.009 --> 00:11:59.129 incentive care monitoring system blood gas analyser used in the open heart surgery. But 00:11:59.129 --> 00:12:05.939 in the medical device rule only the definition has been defined, but the medical devices 00:12:05.939 --> 00:12:12.350 based on the category notified by the Ministry of Health and Family Welfare Government of 00:12:12.350 --> 00:12:21.269 India. The products are classified based on the risk and the parameter as prescribed in 00:12:21.269 --> 00:12:30.189 medical first schedule of medical device rule 2017. 00:12:30.189 --> 00:12:37.730 Also the medical device rule 2017 includes definition of invasive medical devices, which 00:12:37.730 --> 00:12:45.230 state that invasive devices means a devices which in whole or part penetrates inside the 00:12:45.230 --> 00:12:53.769 body either through a body orifice or throughout the surface of the body. Example of this type 00:12:53.769 --> 00:13:03.619 of invasive devices are sutures, hypodermic needles and syringes. Active implantable medical 00:13:03.619 --> 00:13:08.769 devices also defined in the medical device rule 2017 active medical devices which is 00:13:08.769 --> 00:13:18.489 intended to be totally or partially introduced, surgically or medically, into the human body 00:13:18.489 --> 00:13:27.649 or animal body or by the medical intervention into a natural orifice and which is intended 00:13:27.649 --> 00:13:34.139 to remain after the procedure. Active implantable medical devices examples are cardiac pacemaker 00:13:34.139 --> 00:13:39.670 and defibrillators people discuss in the previous slides. 00:13:39.670 --> 00:13:47.160 Active medical devices also defined in the medical device rule in 2017 which state that 00:13:47.160 --> 00:13:53.480 medical devices, relying for its functioning on a source of electrical energy or any source 00:13:53.480 --> 00:14:03.339 of power other than that directly generated by human or animal body or gravity. 00:14:03.339 --> 00:14:10.140 Also then medical device rule 2017 define implantable medical devices which means, it 00:14:10.140 --> 00:14:19.529 is intended for the medical devices intended for to be totally or partially introduced 00:14:19.529 --> 00:14:30.410 into the human or animal body or a natural orifice or to replace an epithelial surface, 00:14:30.410 --> 00:14:38.319 or the surface of the eye by surgical intervention, and which is intended to remain after the 00:14:38.319 --> 00:14:48.129 procedure for a at least thirty days, and which can only be removed by the medical or 00:14:48.129 --> 00:14:53.350 surgical intervention. What type of devices are regulated under which 00:14:53.350 --> 00:14:59.819 category and what will be the classification of the that medical devices? So, concentrate 00:14:59.819 --> 00:15:07.509 on the lecture which will be given again by Mister Malay Mitra former the deputy drug 00:15:07.509 --> 00:15:13.319 controller. He will explain all those thing and concentrate on the lecture and also enjoy 00:15:13.319 --> 00:15:26.299 the lecture thank you very much. Hi, today we will talk about different types 00:15:26.299 --> 00:15:32.850 of medical devices including combination devices. We whenever we go to the market or we decide 00:15:32.850 --> 00:15:37.350 to select a medical device to manufacture or design we find that there are hundreds 00:15:37.350 --> 00:15:43.439 of hundreds of different types of medical devices available in the market. Andwe are 00:15:43.439 --> 00:15:49.540 we are actually confused as to what kind of medical device that is whether its combination 00:15:49.540 --> 00:15:54.769 device, it is a single use device or how do you go about it. So, this short presentation 00:15:54.769 --> 00:16:00.089 will give you a general idea of the types of medical devices moving in the market including 00:16:00.089 --> 00:16:05.769 combination devices. A device you must understandthe definition 00:16:05.769 --> 00:16:12.509 of a device actually to get into focus of combination devices. What is the device? The 00:16:12.509 --> 00:16:16.550 device according to the definition can be anything from as simple as a walking stick 00:16:16.550 --> 00:16:22.570 to an ultrasound machine. So, you can understand the huge range a medical device has got. It 00:16:22.570 --> 00:16:29.119 can be a simple device it can be very very complicated device which is not a accessible 00:16:29.119 --> 00:16:31.470 and usable for a common man. 00:16:31.470 --> 00:16:36.160 However, regulations and controls apply to devices which are notified in the Gazette 00:16:36.160 --> 00:16:42.489 of India. The regulations applied to manufacture sale and import of for obvious reasons. In 00:16:42.489 --> 00:16:48.379 India the devices which are controlled are actually notified in the Gazette of India 00:16:48.379 --> 00:16:57.049 and the whole range of a manufacture, testing,sale etcetera are controlled under the government. 00:16:57.049 --> 00:17:04.030 And there are 15 types of devices and about 3 or 4 more devices are going to be incorporated 00:17:04.030 --> 00:17:16.649 from2020 and these 15 devices which areactual medical devices are controlled under the law. 00:17:16.649 --> 00:17:20.110 And this also includes 4 in vitro medical devices. 00:17:20.110 --> 00:17:25.240 In vitro medical devices the road medical devices in which are used outside the human 00:17:25.240 --> 00:17:33.440 body for detecting orfinding out a disease in the human body and these 4 in vitro medical 00:17:33.440 --> 00:17:38.130 devices are basically used for testing of human blood. 00:17:38.130 --> 00:17:43.130 Let us check the definition of device again as per the Drug and Cosmetics Act, in 1940. 00:17:43.130 --> 00:17:49.100 This will be useful because we must remember that as long as we deal with anything concerning 00:17:49.100 --> 00:17:54.009 the control substandard under the Drug and Cosmetics Act we should keep the definition 00:17:54.009 --> 00:18:00.690 in mind always. This will give a perspective to the product that we are dealing with. In 00:18:00.690 --> 00:18:09.510 part b drug includes all medicines for internal or external use of human beings and animals 00:18:09.510 --> 00:18:14.559 and all substances intended to be used for or in the diagnosis, treatment, mitigation 00:18:14.559 --> 00:18:19.880 or prevention of any disease or disorder in human beings or animals, including preparation 00:18:19.880 --> 00:18:24.790 applied on human body for the purpose of repelling insects like mosquitoes. 00:18:24.790 --> 00:18:32.380 This particular definition is actually completely applied on drugs. Medicines which we call 00:18:32.380 --> 00:18:39.480 them tablet, liquid, capsules etcetera. The part 2 of of the definition say such substances 00:18:39.480 --> 00:18:46.210 other than food intended to affect the structure or function of the human body or intended 00:18:46.210 --> 00:18:51.960 to be used in the destruction of vermin or insect which cause disease in human beings 00:18:51.960 --> 00:18:57.130 or animals or as may be specified from time to time by central government by notification 00:18:57.130 --> 00:19:02.240 in the official gazette. So, in this case the part mark red that is 00:19:02.240 --> 00:19:09.050 intended to affect the structure of function of the human body. Actually refers to a device 00:19:09.050 --> 00:19:13.940 in a way, if you see the function of a device they are there is sometime affect the structure 00:19:13.940 --> 00:19:18.970 of function of the human body. All substances the next parts is all substances integrated 00:19:18.970 --> 00:19:23.940 for use of the components of a drug including empty gelatine capsules etcetera this is also 00:19:23.940 --> 00:19:29.730 applicable to drugs pure drugs. Forth one is such devices intended for internal 00:19:29.730 --> 00:19:34.760 or external use in diagnosis, treatment, mitigation or prevention of diseases or disorder in human 00:19:34.760 --> 00:19:39.880 beings or animals, as may be specified from time to time by the central government by 00:19:39.880 --> 00:19:43.270 notification in the official gazette, after consultation with the board. This portion 00:19:43.270 --> 00:19:51.460 is completely on medical devices as we know it. This definition per se is not a comprehensive 00:19:51.460 --> 00:19:56.899 definition of a medical device, but this particular portion actually refers to medical devices 00:19:56.899 --> 00:20:00.809 that we actually know. Now, this is actually the gazette replica 00:20:00.809 --> 00:20:05.500 of the gazette which actually just for the information to tell you that this is what 00:20:05.500 --> 00:20:14.960 a gazette looks like. The medical in the medical device regulations which came out in 2017 00:20:14.960 --> 00:20:23.570 the 17 regulation there are definitions again given for medical devices. These are a bit 00:20:23.570 --> 00:20:32.360 more comprehensive to and there are definitions also which givea focus on the medical device 00:20:32.360 --> 00:20:37.909 as they exist. It says medical device means rule 3 definition 00:20:37.909 --> 00:20:45.710 ZB medical device means, substances used for in vitro diagnosis and surgical dressings, 00:20:45.710 --> 00:20:49.919 surgical bandages, surgical staples, surgical sutures, surgical ligatures, blood and blood 00:20:49.919 --> 00:20:56.410 components, collection bag with or without anticoagulant covered under sub clause i. 00:20:56.410 --> 00:21:02.539 Now, let us let us look at this one very carefully substance used in in vitro diagnosis and surgical 00:21:02.539 --> 00:21:12.389 dressing, surgical bandage, surgical staples. It says surgical dressings and surgical bandages 00:21:12.389 --> 00:21:19.300 we must remember one thing these two items were also covered in the Indian pharmacopoeia 00:21:19.300 --> 00:21:25.129 as drugs earlier. Now this has been brought clearly under the medical device definition. 00:21:25.129 --> 00:21:33.639 Similarly, blood collection bag earlier was not a device, but this has been brought under 00:21:33.639 --> 00:21:39.039 a device. Earlier it was just a container for collection of whole human blood or components 00:21:39.039 --> 00:21:45.179 orwith a coagulant or an empty bag. These were not medical devices earlier, but this 00:21:45.179 --> 00:21:49.419 has been clearly covered under the medical device definition now. 00:21:49.419 --> 00:21:57.330 B says substances including mechanical contraceptives condoms, intrauterine, tuber rings and disinfectant 00:21:57.330 --> 00:22:03.539 these four items were earlier covered under the definition of drug and are controlled 00:22:03.539 --> 00:22:09.140 as drug under the Drug and Cosmetics Act. This is very clearly brought under the medical 00:22:09.140 --> 00:22:16.100 devices by the new regulations. Devices notified from time to time under sub clause 4 sub of 00:22:16.100 --> 00:22:24.870 clause b of the section 3 of the act. Now this this particular definition c is is the 00:22:24.870 --> 00:22:31.549 is the defining definition which enables the government of India to notify medical devices 00:22:31.549 --> 00:22:36.279 as an when required. So, as I discussed earlier there are 15 medical 00:22:36.279 --> 00:22:41.230 devices covered under the act they have notified under this section. Explanation for these 00:22:41.230 --> 00:22:46.149 rules substances used for in vitro diagnostic shall be referred to as in vitro diagnostic 00:22:46.149 --> 00:22:52.990 medical device. So, medical device when it is in vitro which is which is basically a 00:22:52.990 --> 00:22:59.750 chemical entity or a biological entity for testing of humanbody outside the human body 00:22:59.750 --> 00:23:04.940 are in vitro medical devices they are also medical devices, but known as in vitro medical 00:23:04.940 --> 00:23:10.279 devices. It is therefore, apparent that devices constitute 00:23:10.279 --> 00:23:15.350 a huge variety of items, devices can be as simple as a walking strip to a compressor 00:23:15.350 --> 00:23:20.639 items that the MRI is software even software used for analyzing data is a medical device. 00:23:20.639 --> 00:23:26.100 So, if you have got a MRI machine having a software installed in it and a computer system 00:23:26.100 --> 00:23:32.870 attached to it they are all part of a medical device. Due to late entry of into the regulatory 00:23:32.870 --> 00:23:37.500 framework, general awareness amongst professionals in the country is low. This is this is a fact 00:23:37.500 --> 00:23:44.710 thatthe definition of medical device amongst professionals and a common people are very 00:23:44.710 --> 00:23:48.690 very low.s Because it has not been invoke legally in 00:23:48.690 --> 00:23:56.210 our country all these years. There has been some sort of control, but not regular comprehensive 00:23:56.210 --> 00:24:04.090 control. This is been rectified by the government as an ongoing process by law. What is now 00:24:04.090 --> 00:24:10.549 we come back to combination device. The medical device regulations in our country, as on they 00:24:10.549 --> 00:24:16.419 do not to defined combination devices, but it is essential that we know about it. 00:24:16.419 --> 00:24:24.970 USFDA however, has an effective and useful regulation in CFR 3.2 e which is reproduced. 00:24:24.970 --> 00:24:34.789 It says a product comprised of two or more regulated component that is drug or device 00:24:34.789 --> 00:24:42.720 or biologic a device, drug or biologic or drug device biology. That are physically chemically 00:24:42.720 --> 00:24:48.899 or otherwise combined or mixed and produced as a single entity. That means, a drug or 00:24:48.899 --> 00:24:56.240 a device a biological substance or a device a drug and a biological substance and a drug 00:24:56.240 --> 00:25:02.070 a biological substance and a medical device. If they combined together constitute a medical 00:25:02.070 --> 00:25:07.749 devicecombination device. Two or more separate products package together in a single package 00:25:07.749 --> 00:25:13.070 or a unit and comprised of a drug and device products device and biological products or 00:25:13.070 --> 00:25:19.950 biological entire product. That is a packaged kit is also a combination device as for the 00:25:19.950 --> 00:25:26.100 USFDA definitions. This is not available in ourdefinitions; however, 00:25:26.100 --> 00:25:32.920 there are aspects in the regulations which covers this separately. A drug or device or 00:25:32.920 --> 00:25:37.049 a biological product packaged separately that according to its investigational plan or proposed 00:25:37.049 --> 00:25:43.240 labelling is intended for use only with an approved indigenous specified drug, device 00:25:43.240 --> 00:25:47.809 or biological product where both are required to to achieve the intended use indication 00:25:47.809 --> 00:25:53.519 of effect. And where upon approval of the proposed product the labelling of the approved 00:25:53.519 --> 00:25:58.149 product would need to be changed that is reflected change in the intended use those just form 00:25:58.149 --> 00:26:02.639 strength router registration on significant change in those. 00:26:02.639 --> 00:26:08.990 This is also a medical device. That means, we packet separately drug, device or biological 00:26:08.990 --> 00:26:16.570 product which are packed separately and intended for use with an approved individually specified 00:26:16.570 --> 00:26:24.389 drug for biological product is also a combination device. You cannot use it without a individual 00:26:24.389 --> 00:26:28.240 product which is required to be used with that device. 00:26:28.240 --> 00:26:33.779 Now, some of the question and answers about the are over here with the simple one; however, 00:26:33.779 --> 00:26:40.059 you will be getting much more question and answers we have to submit later on for assessment. 00:26:40.059 --> 00:26:52.960 So, that is over all. Thank you very much.