SMTA Urges Govt To Formulate Separate Act For Medical Devices Industry

511934144 Hospital operating room with monitors and equipment

New Delhi : The Surgical Manufacturers & Traders Association (SMTA) has urged the Union Health Ministry to formulate a separate Act for the Medical Devices industry with a separate regulator and redefine the definition of Medical Devices in the proposed New Drugs, Medical Devices and Cosmetics Bill.

Submitting its comments, observations and opposition on various sections of the draft bill, the Association said that the representatives of Micro, Small and Medium Enterprises (MSME) should be included in the Medical Devices Technical Advisory Board and educe various fees related to testing and approval of medical devices by the regulatory authorities.

The representation said that the Medical Devices Act should be independent of the Drug Act. There should be an altogether separate act for medical devices and the regulation of the same should be independent of the CDSCO, under the ministry of health.

Medical devices are not drugs or pharmaceuticals and nor are the intended use similar to them, and, hence should not be regulated under any such department/authority which is primarily trained to regulate drugs/pharmaceuticals and chemicals.

Stringent regulation by the drug authority will only suffocate the mass MSME entrepreneur of the medical device industry, and shall fail the government’s long term vision of Make in India.

“We propose, Medical Device Controller General of India (MDCGI) similar to the DCGI being head for Medical Devices Regulation,” said the Association.

Under the Section 1 Zd of the draft bill, definition of ‘Medical Devices’ should exclude all devices that are either non sterile, non-invasive or non-implantable or for transient use only.

It proposed that the government may consider only those devices to be brought under the ambit of this definition that are sterile, implantable, invasive by nature except for transient use.

Under Section 1 zb (c), the definition of manufacture should exclude packing, labeling of devices that are sourced from licensed mfr/importer. Also mere designing a product which is just making a blue print of a future device and not manufacturing the device itself and hence should be kept out of the definition of Manufacturing.

Under Section 6, Constitution of Medical Device Technical Advisory Board, should also include one representative member from each of MSME firm categories including importers, exporters, manufacturers and traders, as each vertical has its own contributions and complications to adhere/comply each time a new act/law/license is constituted.

“The representation from the MSME sector should be given a priority, as they are wide spread, and they act as the real link between the department and the trade, and fact fully help in conveyance of the governments intent in imposition of any law/license. Their absence from stake holder meetings lead to utter confusion in business and total disruption of the supply chain,” it added.

“It is also felt that the absence of representation of the MSME in the stake holder’s meetings, distances/totally cuts the government’s hand-holding with the masses. Resulting in non-adherence, non-compliance of the law and Corruption,” averred SMTA representation.

Segregation of IVD from medical devices, is requested, herein, equipment and glassware could be a part of medical devices and, tests, chemicals, kits and reagents could be a part of the drugs.

Under Section 1 zd (b) IVD reagents, reagent products, calibrators, control kits could be included under drugs instead of Medical Devices.

Risk classification of the equipment should be done by the manufacturer.

Refer Section 125 (1) risk classification of the equipment should be done by the manufacturer as per intended use of the medical device which is a global practice followed in the medical device industry.

The device usage or its selection should be done by the user depending on the class it has been included into.

For example, a non-invasive BP Instrument which is classified in Risk Category B, it is used for the first general assessment on the other hand, an invasive BP is used only in the ICU’s and the operating rooms, should ideally be classified in higher Risk Categories, C or D directly as per Manufacturer’s Risk Classification.

Any such activity initiated at the manufacturers end will only help in proper selection of the product, proper usage of the product and proper application by the user.  With this, the most important, compliance by the Medical Device Professional (user) shall never get over looked.

Separate permission/license should not be required for re-packing, of non-sterile, non-invasive, non-implantable or for transient use provided traceability is available/documented with the re-packer.

Medical devices governed under the proposed bill should be free of all other product related regulation, of all other acts like, Legal Metrology, Drug Act, etc. This one and only single proposed law should be applicable to medical devices for ease of business and compliance of law, demanded the Association.

For instance, in the current situation, for basic patient assessment, by the doctor, a weighing scale is required, the same is governed under the legal metrology and is likely to be covered by the CDSCO also shortly. Similarly, a BP Instrument is licensed by both the CDSCO and legal metrology.

Testing fees for all medical devices should be kept at bare minimum/nominal rates so that it is not added to the costs of equipment and thereby resulting in high treatment cost to the patient. The cost of testing the Medical Device/ the testing fees should be specifically mentioned in the proposed bill.

Further all NABL approved labs should be automatically approved to be a Medical Device Testing Laboratories (MDTL), for necessary and faster compliance of the law.

The proposed bill should create a separate regulatory all together for medical devices and so should the governing body or the Medical Device Technical Advisory Group should be appointed separately instead of a combined drug act committee which will always tend to mix and confuse the system. And this separate committee should have the powers to regulate its procedures which should be laid down as standard operating procedures, which are publicly published before enforcement.

Before any notification is issued a draft notification should be issued seeking objections and suggestions of the public and stake holders.

Imported medical devices should not be subjected to testing at ports. Instead, batch testing reports from overseas suppliers should be the accepted standard norm and practice.

Section 123 of the Draft Bill holds the Medical Devices at par with Ayurveda, Unani, Siddha, Sowa – Rigpa etc. “We would like to know what is the basis of evaluating these together and how could the medical devices be kept at par with Ayurveda, Unani, Siddha, Sowa – Rigpa etc., hence exclusion of medical devices from this section is requested,” it said.

Reports should only be required and published for high risk devices, which are implantable, invasive and sterile and should exclude devices that are non-sterile, non-implantable, non-invasive and those that are for transient use only.

It also requested the Ministry to specify and notify quality standards for all medical devices instead of keeping product quality an open chapter or accept international quality standards as previously laid down in ISO or IEC norms, or which are as per globally accepted standards and norms.

Export of medical devices should be free from free sale certificate. Every buyer country has its norms and they decide on its quality and buying processes. There should be no stricture on exports.

Instead of license or permission a simple online registration should be made applicable as also proposed under draft notification issued by the ministry in February, 2022.

Imported medical devices should not be subjected to testing at ports as they being voluminous it would lead to utter chaos and huge cost overlays. Instead, batch testing reports from overseas manufacturers should be the accepted as standard norm.

Mandatory content of the labeling required under Section 127 (b) should be mentioned in detail in advance.

Refering to the Section 133 (3) of the Draft, SMTA opined that as many department employees run businesses in the names of their family members, not just the person who has any financial interest but also if any of his extended family has financial interest or is involved in import or manufacturing or sale of medical devices such person shall not be appointed as medical device officer.

It has also request to delete the clause and applicability of Criminal Procedure Code, 1973.

The License fees should be reduced so as under 19(i) the license for manufacture should be fixed as Rs. 5,000, under 19(ii) approval/product fee should be fixed at Rs 500, under 20 (a) Import License at Rs. 10,000, under 20 (b) per product Rs. 1,000, under 21 (I) License for sale Rs. 1,000 and no fee should be charged for inspection.

The Association has also sought abolition of Licence for Sale to be replaced with Simple Registration system as per draft notification in February 2022.


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