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