The recent Instruction No. 08/2024-Customs issued by the Ministry of Finance, Department of Revenue, highlights significant exemptions for the import of high-end medical equipment, barring critical care devices.
Detailed Analysis
1. Regulatory Background: The Instruction references the Ministry of Environment, Forest and Climate Change (MOEFCC) notifications regarding Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2022. Notably, this amendment permits the importation of high-end medical equipment, excluding critical care devices, under specific conditions.
2. Import Conditions: The MOEFCC categorizes high-end medical equipment, other than critical care devices, under Part ‘B’ of Schedule III of the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. Importation is permissible for actual users, Original Equipment Manufacturers (OEMs), Indian subsidiaries of OEMs, or traders acting on behalf of actual users, subject to approval and conditions stipulated by the MOEFCC.
3. List of Permissible Equipment: The MOEFCC has provided a comprehensive list of 50 high-end and high-value used/refurbished medical equipment, excluding critical care devices, permitted for importation. This list, detailed in previous communications, serves as a guide for stakeholders navigating the import process.
4. Critical Care Equipment Prohibition: Critical care medical equipment, listed under Basel No. B1110 of Schedule VI of the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016, remains prohibited for importation for re-use. This prohibition is underscored to maintain regulatory compliance and uphold safety standards.
5. Awareness and Compliance: The Instruction emphasizes the need for sensitizing officers regarding these regulatory amendments. It encourages proactive measures to address any difficulties encountered during implementation, with a directive to escalate concerns to the Board for resolution.
Conclusion
The Instruction signifies a pivotal development in the regulatory landscape governing the importation of medical equipment in India. By aligning with MOEFCC directives and complying with import conditions, stakeholders can navigate the import process seamlessly while ensuring adherence to environmental and safety standards.
As these regulations aim to balance healthcare facilitation with regulatory oversight, stakeholders must remain vigilant and proactive in their compliance efforts. Clear communication, heightened awareness, and diligent adherence to guidelines will be instrumental in ensuring a smooth transition and sustainable import practices in the healthcare sector.
Your cooperation in implementing these directives is crucial for maintaining regulatory integrity and fostering a conducive environment for healthcare innovation and accessibility.
Should you require further clarification or guidance on navigating these regulatory changes, do not hesitate to reach out to the relevant authorities or seek professional assistance.
F.No.401/40/2021-Cus.I I I
Government of India
Ministry of Finance, Department of Revenue
(Central Board of Indirect Taxes & Customs)
Instruction No. 08/2024-Customs | Dated : 05.04.2024
Room No.229A, North Block,
New Delhi, Dated, 05.04.2024
To
All Principal Chief Commissioners/ Chief Commissioners of Customs/ Customs (Preventive) /Customs and Central Taxes
All Principal Commissioners/ Commissioners Customs/ Customs (Preventive) All Principal Director Generals/Director Generals under CBIC
Subject: – : Exemption for import of High End and High Value used Medical Equipment other than critical care medical equipment Hazardous and Other under Wastes (Management and Transboundary Movement) Second Amendment Rules, 2022 dated 23rd December, 2022- reg
Madam/Sir,
Reference is invited to Ministry of Environment, Forest and Climate Change (MOEFCC) (HSM Division) OM dated 15.12.2023 enclosing OM dt. 19.06.2023, 19.05.2023 and 06.07.2023 (copies attached.) and Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2022 on 23rd December, 2022
2. Vide above OM, MOEFCC has stated that Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2022 dated 23rd December, 2022 where notified wherein High End and High Value Used Medical Equipment other than Used Critical Care Medical Equipment is included in Part ‘B’ of Schedule III of Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 (HOWM Rules, 2016) and are allowed to be imported by actual user or by Original Equipment Manufacturers (OEM) or Indian Subsidiary of OEM or Trader on behalf of actual user for reuse. Further, it has been informed that as this item falls under Schedule III Part ‘B’ of HOWM Rules, 2016, hence import of above referred equipment is restricted and cannot be imported without permission from the MOEFCC, with conditions imposed in the permission.
3. In this regard, A list of 50 High End and High Value used/refurbished Medical Equipment other than critical care medical equipment have been provided vide MoEFCC OM dated 19.06.2023, which have been allowed to be imported as per above mentioned conditions.
4. It is to note that, Used Critical care medical equipment is covered under Basel NO. B1110 of Schedule VI of the HOWM Rules, and is prohibited for import for re-use. For reference, MoEFCC vide their OM dated 19.05.2023 (copy attached) has provided a list of 14 critical care medical equipment as follows:
i. High End Ventilators
ii. Nitric Oxide Generator
iii. Flexible Bronchoscope
iv. ABG Machines
v. Haemodialysis machines
vi. Continuous Renal Replacement Therapy (CRRT)
vii. CO,SVR, ScvO2 Monitor
viii. Intubating video scope
ix. ICU dedicated Ultrasound and Echo Machine
x Beside X-ray machine
xi. Extra-Corporeal Membrane Oxygenator (ECMO)
xii. IABP
xiii. Percutaneous dilatation tracheostomy kit
xiv. Defibrillator with transcutaneous pacemaker
5. It is requested that necessary action may be taken to sensitize officers under your jurisdiction regarding the said matter. The difficulties, if any, may be brought to the notice of the Board.
Hindi version follows
Encls: as stated above.
Yours faithfully,
(R.Ananth)
Director (Customs)
Email: [email protected]
Tele: 011 23093908
FTS: 3529261
F. No. 23/104/2022-HSMD
Government of India
Ministry of Environment, Forest and Climate Change
(HSM Division)
Jal Block, 2nd Floor,
Indira Paryavaran Bhawan,
Jor Bagh Road, Aliganj,
New Delhi – 110003
Date: 15th December, 2023
OFFICE MEMORANDUM
Subject: List of High End and High Value used Medical Equipment other than critical care medical equipment- reg.
This is in continuation to this Ministry’s OM of even number dated 19th June, 2023 providing therewith list of Hi h End and Hi h Value used/refurbished Medical Equipment other than critical care medica equipment, as suggested by DGHS, which can be imported. However, this import is subject to a number of conditions and is restricted. A representation has been received in this regard stating that above policy is not being followed strictly.
2. Hence, it is once again clarified that above referred High End and High Value Used Medical Equipment other than Used Critical Care Medical Equipment is allowed to be imported by actual user or by Original Equipment Manufacturers (OEM) or Indian Subsidiary of OEM or Trader on behalf of actual user for re-use. Further, this item falls under Schedule III Part ‘B’ of HOWM Rules, 2016, hence import of above referred equipments is restricted and cannot be imported without permission from the Ministry of Environment, Forest and Climate Change, with conditions imposed in the permission. The OMs dated 19th June, 2023 and 6th July, 2023 are enclosed for ready reference.
3. This OM is in supersession of earlier OMs and any permission given earlier (before 19th June, 2023) is not valid.
4. This issues with the approval of the Competent Authority.
(Ved Prakash Mishra)
Director
To,
1. The Director General, Directorate General of Foreign Trade, Udyog Bhawan, H-Wing, Gate No.2, Maulana Azad Road, New Delhi – 110011.
2. The Chairman, Ministry of Finance, Department of Revenue, Central Board of Indirect Taxes and Customs, North Block, New Delhi – 110 001.
3. The Joint Secretary (Customs), Ministry of Finance, Department of Revenue, Central Board of Indirect Taxes and Customs, North Block, New Delhi – 110 001. (to ensure the compliance please).
F. No.23/ 1 04/2022-11SMD
Government of India
Ministry of Environment, Forest and Climate Change
(HSM Division)
Level II Jul Block.
Indira Paryavaran Bhawan, jor Bath Road, Ali Ganj,
New Delhi – 110003
Date: 6th July, 2023
Subject: Representation against permission to allow import of High End and High value used Medical Equipment other than critical care medical equipment – reg.
This has reference to e-mail dated dated 04.07.2023 received from Deputy Director General of Foreign Trade, Directorate General of Foreign Trade (DGET), Department of Commerce (DoC), Ministry of Commerce forwardirig the representation of Mis SS Innovations Pvt Ltd expressing concern regarding the import and use of refurbished/re-use medical equipment’s, particularly Robotic Assisted Surgical System, Instruments and Accessories. Dy. DGFE seek inputs/comments of MoEFCC on the same. Reference is also invited to several representations received in the Ministry regarding Ministry’s notification dated 23’d December, 2022 allowing import of High End and High value used Medical Equipment other than critical care medical equipment tbr re-use purpose and OM dated 19th June,.2023 providing list of High End and High value used Medical Equipment other than critical care medical equipment.
2. In this regard, it is to inform you that Ministry were in receipt of various representations from FICCI, All India Pre-Owned Medical Equipment Supplier Association and Other Associations regarding import of Pre-owned/ Refurbished devices & Clarification regarding import of Critical Care Medical Equipment. Repeated request were alSo made to allow import of used medical equipment by third party so as to facilitate smaller healthcare facilities. These representations were referred to Technical Review Committee (TRC) constituted in the Ministry. TRC considering the prevailing status of medical facilities in the country and difficulties faced by small health care facilities in importing the costly high end devices and maintenance Thereof, recommended the import of High End and High Value Used Medical Equipment other than Used Critical Care Medical Equipment by actual user or by Original Equipment Manufacturers (OEM) or Indian Subsidiary of OEM or Trader on behalf of actual user for re-use. This will not only facilitate smaller health care facilities in Tier-11/111 cities but also provide affordable medical services to poor people.
TRC while recommending import of High End and High Value Used Medical Equipment other than Used Critical Care Medical Equipment inter-alia suggested that (i) Such equipment has not been phased out from the importing country and is not considered obsolete in that country; (ii) Such equipment does not contain any hazardous material/ substances listed under any international regulation/ law and or by government of India; (iii) The equipment must have a minimum residual life of 7 years (as specified by Chartered Engineer of exporting country) for which supplier or manttfacturer must provide hardware and software support including warranty: (iv) “lhe importer shall dispose the equipment alter the end life as per the l-waste rules, 2016,
3. The above recommendation of ‘me were accepted by the Ministry and accordingly, Ministry amended Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 and allow import of High End and High Value Used Medical Equipment other than Used Critical Care Medical Equipment.
4. Further, Directorate General of I lealth Services (1)(.illS), Ministry of I lealth & Family Welfare IFW) vide GM dated 5th June. 2023 forwarded list of High End and I ligh Value used Medical Equip, ment other than critical care medical equipment along with Terms and Conditions for import for reuse purpose which inter-alia includes that ‘equipinent manufactured in India should not be imported, as per “Make in India’ policy’. Thereafter, GM dated 19’h June. 2023 was issued by the Ministry providing list of High End and High value used Medical.Equipment.
5. In the light of above, it is to clarify that the suggestions given by TRC and DCHS. MoHEW will be taken into account while considering the application of import of High End and High value used Medical Equipment other than critical care medical equipment. The import permissions will be given by the Expert Committee of the Ministry with specified conditions and all the concerns raised in this regard will be duly considered, including ‘make in India Policy; and Atinnirbhar Bharat Policy of the Government.
This has approval of the cot ipetent authority,
Yours sincerely
(Ved Prakash Mishra) Director
Email: [email protected]
Phone No.: 011-20819236
To,
Ministry of Commerce and Industry
(Kind Attn: Shri Sanjay Kumar Tiwari, Dy Director General of Foreign Trade)
Department of Commerce,
Directorate General of Foreign Trade,
lidyog I3hawan, New Delhi.
Email: [email protected]
Copy to (through email):
1. The Managing Director. Accuster Technologics. Plot No. 424 CMR Building, (Anton* New Delhi – 110030.
2. The Director, Status Medical Equipments Pvt Ltd, M-9/A, Addl. MIDC, Satara, Maharashtra.
3. The Managing Director, Serwell Medi Equip (P) Ltd., 2, 1st floor. T.V. nagar, Ramapurain, Chennai.
4. The President, Prognosys Medical System Pvt Ltd., # 249, 4th Main Road, Chamarajpet, Bangalore – 560018.
5. The Managing Director, Xcellance Medical Technoligies Pvt. Ltd., Shalya Avenue, W-239, MIDC, TIC Industrial Area, Navi Mumbai, Maharashtra.
6. The Director, Alan Electronics Systems Pvt. Ltd., F-75. MIDC Additional Ambernath Industrial Area, Anand Nagar, Thane, Maharashtra.
7. Mitra Medical Services LLP, B-226, Okhla Industrial Area, Phase-I, New 1.1)elhi-110020.
F. No. 23/1.04/2022-HSMD
Government. of India
Ministry of Environment, Forest and Climate Change
(HSM Division)
Jal Block, 2nd Floor,
Indira Paryavaran Bhawan,
Jor Bagh Road, Aliganj,
New Delhi — 110003
Date: 19th June, 2023
OFFICE MEMORANDUM
Subject: List of High End and High Value used Medical Equipment other than critical care medical equipment- reg.
The undersigned is directed to refer to the Directorate General of Health Services (DOHS), Ministry of Health & Family Welfare (MoHFW) OM dated 5th June, 2023 forwarding therewith list of High End and High Value used Medical Equipment other than critical care medical equipment. The list of High End and High Value used Medical Equipment other than critical care medical equipment is as follows:
| S.No. | Name of Equipment |
| 1. | MRI |
| 2. | CT |
| 3. | PET-CT |
| 4. | SPECT/SPECT-CT/Gamma camera |
| 5. | Mammography |
| 6. | High end X ray- Non -ICU |
| 7. | Ultrasound — Non-ICU |
| 8. | Interventional Radiology equipment |
| 9. | C — arm (surgery) |
| 10. | Radiotherapy Device |
| 11 | Microbiology — Microbial identification & AST |
| 12. | Microbiology – detecting systems for the presence or absence of microorganisms in Blood. Sterile body fluids. |
| 13. | Multi parametric immunoassay Analyzer based on ELFA technology |
| 14. | Molecular diagnostic — molecular infectious disease diagnostics systems |
| 15. | Microbiology — advanced mass spectrometry microbial identification system |
| 16. | Blood cell count analyzer |
| 17. | Microscope slide maker / stainer |
| 18, | Chemiluminescent immunoassay analyzer |
| 19. | Clinical chemistry analyzer |
| 20. | Imrnunohetnatology Auto Analyzer |
| 21. | URINE Analyzers |
| 22. | Robotic Assisted surgical system, instruments and Accessories |
| 23. | Femtosecond ophthalmic solid – state laser system |
| 24. | Phacoemulsification and vitrectomy system |
| 25. | Ophthalmic -Exenner Laser system |
| 26. | OCT posterior and anterior segment |
| 27. | Fundus imagine system preferably ultrawide field along with FFA and ICG |
| 28. | Corneal topography |
| 29. | Optical biometer |
| 30. | Clinical corneal specular microscope |
| 31. | High end operating microscope |
| 32. | Ablation system |
| 33. | Endoscopie Camera system |
| 34. | Endoscopes |
| 35. | Orthopedic Robotic Navigation system |
| 36. | Medical – grade monitors |
| 37. | Image Management system |
| 38. | Medical — grade electromechanical drill |
| 39. | Flow control pump |
| 40. | Insufflation device |
| 41. | NCV/EMG system |
| 42. | FIG system |
| 43. | Repetitive transcranial magnate stimulator |
| 44. | Flexible video Ureterorenoscope with Monitor |
| 45. | Video Urodynamic system with chair |
| 46. | Cryo Ablation system |
| 47. | 4K Advance Laparoscopy surgery system |
| 48. | OT integration system |
| 49. | High intensity Focused Ultrasound system |
| 50. | 3D – 4K Laparoscopy system |
2. Ministry of Environment, Forest and Climate Change has notified Hazardous and Other Wastes (Management and Transboundary Movement) Second Amendment Rules, 2022 on 23rd December, 2022 wherein High End and High Value Used Medical Equipment other than Used Critical Care Medical Equipment is included in Part `13′ of Schedule III of Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016 and allowed to be imported by actual user or by Original Equipment Manufacturers (OEM) or Indian Subsidiary of OEM or Trader on behalf of actual user for re-use. It is also mentioned in the amended rules that “High End and High Value Medical Equipment. is such medical equipment as specified by the MoHFW from time to time”.
3. This issues with the approval of the Competent Authority.
(Ved Prakash Mishra)
Director
To,
1. The Joint Secretary,
Department of Health & Family Welfare,
Ministry of Health & Family Welfare,
Nirman Bhawan, New Delhi – 110001.
2. The Deputy Director General,
Directorate General Health Services,
Department of Health & Family Welfare,
Ministry of Health & Family Welfare,
Nirman Bhawan, New Delhi – 110001.
3. The Director General,
Directorate General of Foreign Trade,
Udyog Bhawan, H-Wing, Gate No.2,
Maulana Azad Road, New Delhi – 110011.
4. The Director (Customs),
Ministry of Finance,
Department of Revenue, Central Board of Excise and Customs,
North Block, New Delhi – 110 001.
f.No.401/40/2021-Cus-III
3188591/2023/Cus-III Section
F. No. 23/104/2022-HSMD
Government of India
Ministry of Environment, Forest and Climate Change
(HSM Division)
Jal Block, 2nd Floor,
Indira Paryavaran Bhawan,
Jor Bagh Road, Aliganj,
New Delhi – 110003
Date: 19th May, 2023
OFFICE MEMORANDUM
Subject: List of Critical Care Medical Equipment – reg.
The undersigned is directed to refer to the Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare (MoHFW) letter dated 13th October, 2022 (received in the Ministry through email dated 24th February, 2023) forwarding therewith updated lists of critical care medical equipment. The list of critical care medical equipment provided is as follows:
i. High End Ventilators
ii. Nitric Oxide Generator
iii. Flexible Bronchoscope
iv. ABG Machines
v. Haemodialysis machines
vi. Continuous Renal Replacement Therapy (CRRT)
vii. CO, SVR, ScvO2 Monitor
viii. Intubating video scope
ix. ICU dedicated Ultrasound and Echo Machine
x. Beside x-ray machine
xi. Extra-Corporeal Membrane Oxygenator (ECMO)
xii. IABP
xiii. Percutaneous dilatation tracheostomy kit
xiv. Defibrillator with transcutaneous pacemaker
2. Ministry of Environment, Forest and Climate Change (MoEFCC) has notified Hazardous and Other Wastes (Management and Transboundary Movement) (HOWM) Rules, 2016 and its amendments. The import export of hazardous and other wastes is regulated thorough the said HOWM Rules, 2016. Used critical care medical equipment is covered under Basel No. B1110 of Schedule VI of the HOWM Rules, 2016, and is prohibited for import for re-use.
3. This issues with the approval of the Competent Authority.
(Ved Prakash Mishra)
Director
To,
1. The Joint Secretary,
Department of Health & Family Welfare,
Ministry of Health & Family Welfare,
Nirman Bhawan, New Delhi – 110001.
2. The Deputy Director General,
Directorate General Health Services,
Department of Health & Family Welfare,
Ministry of Health & Family Welfare,
Nirman Bhawan, New Delhi – 110001.
3. The Director General,
Directorate General of Foreign Trade,
Udyog Bhawan, H-Wing, Gate No.2,
Maulana Azad Road, New Delhi – 110011.
4. The Director (Customs),
Ministry of Finance,
Department of Revenue, Central Board of Excise and Customs,
North Block, New Delhi – 110 001.
Reg Import of USED MED EQUIP as per PARA 13 (3 ) of HAZ & OTHER WASTE (MGM & TRANSBOUNDARY) RULE 2016, IF IMPORTER IS HOLDING EPR REGN CERTIFICATE CAN IMPORT USED MED EQUIP LISTED IN SCHEDULE III PART B , WHY THE IMPORT PERMISSION IS DEMANDED BY CUSTOMS FROM MOEFCC , AS PER RULE 2016 PARA 13 (3 ) IMPORTER CAN FREELY IMPORT USED MED EQUIP , PL HELP IN CLARIFYING THIS TROUBLE TO IMPORTER AND TRADE