Import of Diagnostic Kit - Medical device and Drug -Registration, Certification,Testing, labeling and NOC

Import of  Diagnostic Kit

 I. Type of goods

Diagnostic  Kit is a drug under section 3 of the Drugs and Cosmetics Act, 1940 and also a medical device under the Medical Device Rules, 2017.

II. Standardization/ Quality/Certification

i. BIS / ISO / IEC(  International Electro Technical Commission), or by any other pharmacopoeial standards
ii. Conform to manufacturer’s standards
iii. ISO 13485 Certificate

III. Labelling requirement

Under the Drugs and Cosmetics Rules, 1945 and also the Legal Metrology (Packaged Commodities) Rules 2011

IV. Registration / NOC  from CDSCO

Online Registration /NOC for Import of Testing Kit at the website of the Central Drugs Standard Control Organisation. https://cdscomdonline.gov.in/NewMedDev/Homepage
 Testing Kit is not required registration under   CHAPTER IIIA of  Medical Rule 2017.

V. Testing of Diagnostic  Kit ( COVID Kit)
i. Tests by the Drug Controller of India, after the National Institute of Virology validated its test
ii. The National Institute of Biologicals (NIB), NOIDA is designated as a Central Medical Device Testing Laboratory (CMDTL) by Government of India

The Govt has fixed prices of masks (2ply, 3ply), Melt Blown non-Woven Fabric and hand sanitizers

The Central Government has fixed price of masks (2ply, 3ply), Melt Blown non-Woven Fabric and hand sanitizers up to 30th June 2020.

The prevailing price of   12.02.2020 is considered for masks (2ply, 3ply), Melt Blown non-Woven Fabric and hand sanitizers as a fixed price.
https://consumeraffairs.nic.in/sites/default/files/file-uploads/latestnews/Notification21mar2020.pdf

Import of Surgical Mask requires BIS and registration under Rule 27 of the Legal Metrology (Packaged Commodity) Rules, 2011

BIS  for Surgical Mask :

 i. BIS 14166: Respiratory protective devices : Full face masks

 ii. BIS IS 16289 : 2014 | MEDICAL TEXTILES SURGICAL FACE ...

 iii. BIS 9473 prescribes requirements and tests for filtering half masks intended to provide partial

Declaration of MRP on the surgical mask is governed under Legal Metrology (Packaged Commodity) Rules, 2011 

MRP of a unsold stock may be enhanced if there is a increase in the GST upto 30th September 2020

 MRP  declaration - Stamping or Putting sticker or Online printing

Declaration of the changed retail sale price (MRP) shall be made by
way of stamping or putting sticker or online printing, as the case may be, after complying
with the following conditions:

(i) The difference between the retail sale price originally printed on the package and the
revised price shall not, in any case, be higher than the extent of increase in the tax 1f any, or
in the case of imposition of fresh tax, such fresh tax, on account of implementation of GST
Act and Rules.

(ii) The original MRP shall continue to be displayed and the revised price shall not
overwrite on it.

How to inform the consumer about change in the MRP of the goods

 Manufacturers or packers or importers shall make at least two advertisements in one
or more newspapers in this regard and also by the circulation of notices to the dealers and to the
Director of Legal Metrology in the Central  Government and Controllers of Legal Metrology in
the States and Union Territories, indicating the change In the price of such packages.

Time period 

 It is also clarified that any packaging material or wrapper which could not be
exhausted by the manufacturer or packer or Importer prior to revision of GST, may be used
for packing of material up to  30th' September 2020 or till such date the packing material or
wrapper is exhausted, whichever is earlier after making corrections required in retail safe
price (MRP) on account of implementation of G.S.T. by way of stamping or putting sticker or
online printing, as the case may be.
  Source https://consumeraffairs.nic.in/sites/default/files/file-uploads/latestnews/LM_01042020.pdf

COVID19 ; NO Basic Custom Duty and Health Cess- Ventilators, Face Masks , surgical Masks, Personal protection equipment (PPE)

Now,  No Basic Customs Duty (BCD) and  Health Cess ,you can import Ventilators,  Face masks , surgical Masks and Personal protection equipment (PPE) into India without paying BCD & Health Cess.

http://cbic.gov.in/resources//htdocs-cbec/customs/cs-act/notifications/notfns-2020/cs-tarr2020/cs17-2020.pdf;jsessionid=A44C5F7123CAF89EF385E6CA4FE23993


[TO BE PUBLISHED IN THE GAZETTE OF INDIA, EXTRAORDINARY, PART II, SECTION
3, SUB-SECTION (i)]

GOVERNMENT OF INDIA
MINISTRY OF FINANCE
(DEPARTMENT OF REVENUE)

Notification No. 20/2020– Customs
New Delhi dated the 9
th April, 2020
G.S.R. (E).- In exercise of the powers conferred by sub-section (1) of section 25 of the Customs
Act, 1962 (52 of 1962) read with section 141 of Finance Act, 2020 (12 of 2020), the Central
Government on being satisfied that it is necessary in the public interest so to do, hereby exempts the
goods of the description specified in column (3) of the Table below falling within the Chapter,
heading, sub-heading or tariff item of the First Schedule to the said Customs Tariff Act specified in
column (2) of the Table below, from whole of the duty of customs leviable thereon under the First
Schedule to the said Customs Tariff Act and the whole of health cess leviable thereon under section
141 the said of Finance Act, 2020:
Table
2. This notification shall remain in force upto and inclusive of the 30th September, 2020.
 [F.No. 354/41/2020-TRU]
(Gaurav Singh)
 Deputy Secretary to the Government of India
S.No
.
Chapter or
Heading or
sub–heading
or tariff item
Description of goods
(1) (2) (3)
1. 9018 or 9019 Artificial respiration or other therapeutic respiration apparatus (Ventilators)
2. 63 or any
chapter
Face masks and surgical Masks
3. 62 or any
chapter
Personal protection equipment (PPE)
4. 30, 38 or any
chapter
Covid-19 testing kits
5. Any Chapter Inputs for manufacture of items at S. Nos. 1 to 4 above,subject to the condition
that the importer follows the procedure set out in the Customs (Import of
Goods at Concessional Rate of Duty) Rules, 2017.

Infrared thermometer - not covered under BIS

Infrared thermometers  are  not covered under  following  standard of  BIS  

IS 3055 (Part 1)  Clinical thermometers :Part1 Solid stem type

IS 3055 (Part 2) Clinical thermometers :Part 2 Enclosed scale type

GSR No. 843(E) dated 9 Nov. 2001  Clinical Thermometers (Quality Control), 2001

https://bis.gov.in/index.php/product-certification/products-under-compulsory-certification

Infrared thermometer- Legal Metrology - Registrations, Licences , Certificates, Testing , Verification and Nomination

Clinical Thermometers including  Digital Thermometer, Infrared Thermometer and  Contactless thermometer which are used now for a screening of a person to monitor the spread of COVID-19 virus.  Import and sale of these thermometers in India require compliances under Rules and Sections of the Legal Metrology Act, 2009. Minimum of five samples per model is required for product approval.  A brief  list of Registrations,  Licences, Certificates, Testing, Verification  and Nomination required  for compliance of Legal Metrology  is given below:

i.  Registration under Section 19 of the Legal Metrology Act, 2009.

ii.  Registration under Rule 27 of the Legal Metrology ( Packaged Commodities) Rule,2011

iii.  Certificates of Model Approval under Section 22 of the Legal Metrology Act 2009 and the Legal Metrology (Approval of Models) Rules, 2011.

iv.   (If already imported but not obtained prior registrations and approval under Legal Metrology  )   No Objection Certificate ( NOC) for import from the Legal Metrology Division of the  Department Of Consumer Affairs, Ministry Of Consumer Affairs, Food and Public Distribution, Government  Of India.

v.  Certifications of Testing, Verifications and Sealing under Section 24 of the Legal Metrology Act 2009 and the Legal Metrology (Approval of Models) Rules, 2011 and Legal Metrology ( General) Rules, 2011.

vi.  The nomination of Director under section 49(2) of the Legal Metrology Act 2009 and Rule 29 of Legal Metrology (General) Rules, 2011.


If any person requires consulting for compliance under legal metrology may contact us 

Ravindra Kumar
Global Tax Guru
ravindra@globaltaxguru.in

#Budget2019 #presumptive tax limits at Rs 50 Lakh for professional

61. Special benefits and incentives were also given to small businesses and start-ups. Overall compliance processes were simplified. Threshold limit for presumptive taxation of business was raised from Rs 1 crore to  Rs 2 crore. The benefit of presumptive taxation was extended for the first time to small professionals fixing threshold limit at ` 50 lakh. In order to promote a less cash economy, the presumptive profit rate has been reduced from 8% to 6%.  The tax rate for companies with turnover of up to ` 250 crore, covering almost 99% of the companies, was reduced to 25% which was also applicable to new manufacturing companies without any turnover limits.

#Defence Budget of Rs 3,00,000 crore for the first time in 2019-20

47. Our Defence Budget will be crossing ` 3,00,000 crore for the first time in 2019-20. For securing our borders and to maintain preparedness of the highest order, if necessary, additional funds would be provided


India is now on the way to becoming a global manufacturing hub in various sectors including automobiles and electronics, defence and medical devices.

#Artificial Intelligence and related technologies in Budget 2019

42. In order to take the benefits of Artificial Intelligence and related technologies to the people, a National Programme on 'Artificial Intelligence' has been envisaged by our Government. This would be catalysed by the establishment of the National Centre on Artificial Intelligence as a hub along with Centres of Excellence. Nine priority areas have been identified. A National Artificial Intelligence portal will also be developed soon.

#GST in budget 2019, relief to small business and cinema goers

Most items of daily use of the poor and middle class are now in the 0% or 5% tax slab.

  Cinema goers who were subjected to multiple taxes up to 50% are mostly paying much lower tax at 12% now

Exemptions from GST for small businesses has been doubled from ` 20 lakh to ` 40 lakh. 

Further, small businesses having turnover up to ` 1.5 crore have been given an attractive composition scheme wherein they pay only 1% flat rate and have to file one annual return only.

Similarly, small service providers with turnover upto `50 lakhs can now opt for composition scheme and pay GST at 6% instead of 18%.

Budget 2019- abolished Customs duties on 36 capital goods, single point of approval,digitalization of export/ import transactions and leveraging RFID technology for export logistics

Honourable FM Speech

"66. To promote the “Make in India” initiative, we have undertaken rationalization of customs duties and procedures. Our Government has abolished duties on 36 capital goods. A revised system of importing duty-free capital goods and inputs for manufacture and export has been introduced, along with introduction of single point of approval under section 65 of the Customs Act. Indian Customs is introducing full and comprehensive digitalization of export/import transactions and leveraging RFID technology to improve export logistics. " 

Not declaring Retail Price and Net Quantity in same font in Advertisement is violation of the Legal Metrology (Packaged Commodities) Rules, 2011

Declaration of   Retail Price  and Net Quantity  is to be in  same font in the advertisement.

 This is as per Rule 32(1) & (2) of the Legal Metrology (Packaged Commodities) Rules, 2011 as reproduced below:
”(1) Any advertisement mentioning the retail sale price of the pre-packaged commodity shall contain a declaration as to the net quantity or number of the commodity contained in the package.
(2) The font size of the net quantity in the advertisement shall be same as that of the retail sale price”.

Passenger name record information and crew manifest

Passenger name record information and crew manifest

providing the passenger and crew manifest for arrival and departure and passenger name record information.

Section 157 is being amended so as to empower Board to make regulations for

specifying the form, particulars, manner and time of providing the passenger and crew

manifest for arrival and departure and passenger name record information and penalty

in the case of delay in delivering the information.

New procedures for settlement Commission

Change in Settlement Commission procedures

Section 127B is being amended so as to insert a new sub-section (5) therein to enable

any person, other than applicant, referred to in sub-section (1) to make an application

to the Settlement Commission.

Sub-section (3) of section 127C is being amended so as to substitute certain words

therein. It further seeks to insert a new sub-section (5A) therein to enable the

Settlement Commission to amend the order passed by it under sub-section (5), to

rectify any error apparent on the face of record.

Warehouse facility for imported and exported goods

Storage / Warehouse facility for imported goods

Section 49 is being amended to extend the facility of storage under section 49 to

imported goods entered for warehousing before their removal. 

Storage / Warehouse facility for Exported goods

Section 69 relating to clearance of warehoused goods for exportation is being

amended to align it with the proposed omission of section 82.

Mandatory filing of B/E and duty and interest

Mandatory to file the bill of entry before the end of the next day

Sub-section (3) of section 46 is being substituted so as to make it mandatory to file the

bill of entry before the end of the next day following the day (excluding holidays) on

which the vessel or aircraft or vehicle carrying the goods arrives at a customs station

at which such goods are to be cleared for home consumption or warehousing and to

provide for imposition of such charges for late presentation of the bill of entry as may

be prescribed.

Payment of duty and interest thereon

Sub-section (2) of section 47 is being amended so as to provide the manner of 

payment of duty and interest thereon in the case of self-assessed bills of entry or, as

the case may be, assessed, reassessed or provisionally assessed bills of entry.

Obligatory for person-in charge Of a conveyance

Obligatory on the person-incharge of a conveyance

A new section 30A is being introduced so as to make it obligatory on the person-incharge

of a conveyance that enters India from any place outside India or any other person as may be specified by the Central Government by notification in the Official Gazette, to deliver to the proper officer the passenger and crew arrival manifest before arrival in the case of an aircraft or a vessel and upon arrival in the case of a vehicle; and passenger name record information of arriving passengers in such form, containing such particulars, in such manner and within such time as may be prescribed. The section also intends to provide for imposition of a penalty not exceeding fifty thousand rupees as may be prescribed, in the case of delay in delivering the information.

A new section 41A is being introduced so as to make it obligatory on the person-incharge of a conveyance that departs from India to a place outside India or any other person as may be specified by the Central Government by notification in the Official Gazette, to deliver to the proper officer the passenger and crew departure manifest and passenger name record information of departing passengers before the departure of the conveyance in such form, containing such particulars, in such

manner and within such time as may be prescribed. The section also intends to provide for a penalty not exceeding fifty thousand rupees as may be prescribed in the case of delay in delivering the information.

Global Tax Guru: Same Advance Ruling Authority for Customs & Income...

Global Tax Guru: Same Advance Ruling Authority for Customs & Income...: Same Advance Ruling Authority for Customs & Income Tax Clause (e) of section 28E is being amended so as to substitute the definiti...

Same Advance Ruling Authority for Customs & Income Tax and new procedures

Same Advance Ruling Authority for Customs & Income Tax

Clause (e) of section 28E is being amended so as to substitute the definition of

“Authority” to mean the Authority for Advance Ruling asconstituted under section 245-O of the Income-tax Act, 1961.

. Section 28F is being amended so as to provide that the Authority for Advance Rulings

constituted under section 245-O of the Income-tax Act shall be the Authority for giving

advance rulings for the purposes of the Customs Act. It further seeks to provide that

the Member of the Indian Revenue Service (Customs and Central Excise), who is

qualified to be a Member of the Board, shall be the revenue Member of the Authority

for the purposes of Customs Act. It also seeks to provide for transferring the pending

applications before the Authority for Advance Rulings (Central Excise, Customs and

Service Tax) to the Authority constituted under section 245-O of the Income-tax Act

from the stage at which such proceedings stood as on the date on which the Finance

Bill, 2017 receives the assent of the President.

Procedurals amendments in working of Authority

Section 28G relating to vacancies not to invalidate proceedings is being omitted.

Sub-section (3) of section 28H is being amended so as to increase the application fee

for seeking advance ruling from rupees two thousand five hundred to rupees ten thousand on the lines of the Income-tax Act.

Sub-section (6) of section 28I is being amended so as to provide time of limit of six months by which Authority shall pronounce its ruling on the lines of the Income-tax Act.