Health & Beauty

Recently,the new crown pneumonia epidemic has spread in India.Ventilators and oxygen concentrators,as important materials to fight the epidemic,are in great demand in India.Chongqing Customs urgently compiled and summarized the export instructions,and introduced relevant companies on how to export medical devices to India smoothly and orderly.

1.Export customs clearance prompt

1. Commodity classification(according to the import and export tariffs of 2021)

   
   

2.Qualifications and materials required for the export of the ventilator

The first situation:the product has obtained my country's medical device product registration certificate and meets the quality standards of the importing country(region)

According to the"Announcement on the Orderly Export of Medical Supplies"(Announcement No.5,2020 of the General Administration of Customs of the Ministry of Commerce and the State Drug Administration of the People’s Republic of China),companies that export ventilators must provide a written or electronic declaration to declare to the customs.Exported products have obtained my country's medical device product registration certificate and meet the quality standards of the importing country(region).The customs shall inspect and release the medical device product registration certificate approved by the drug regulatory authority.

The second situation:the product has obtained foreign standard certification or registration

According to the"Announcement on Further Strengthening the Export Quality Supervision of Anti-epidemic Materials"(Announcement No.12,2020 of the State Administration of Market Supervision and Administration of the Ministry of Commerce and Customs),export enterprises of ventilator products that have obtained foreign standard certification or registration must submit the declaration during customs declaration.An electronic or written statement that the product meets the quality standards and safety requirements of the importing country(region),and the customs has a list of manufacturers certified or registered with foreign standards provided by the Ministry of Commerce(the list is on the website of the China Chamber of Commerce for Import and Export of Medicines and Health Products www.cccmhpie.org.cn dynamic update)inspection and release.

The third situation:the product does not fall within the scope of the above announcement

For products such as ventilator accessories and oxygen generators that are not within the scope of the above announcement,there is no need to provide relevant documents as required by the announcement.However,if it is a medical device,it shall comply with the requirements of the Regulations on the Supervision and Administration of Medical Devices(Order No.680 of the State Council),that is,enterprises exporting medical devices shall ensure that the medical devices they export meet the requirements of the importing country(region).

3.Export tax rebate:The export tax rebate rate of the commodities listed in this article's classification list is 13%

2.Access conditions for medical devices in India

1.India's medical device regulatory agency

The Central Drug Standards Control Organization(CDSCO)under the Ministry of Health&Family Welfare(Ministry of Health&FW)is the central authority for medical devices in India.The Drug Controller General of India(DCGI for short)serves as the national medical device policy-making unit in India.

2.Classification of medical devices

In 2017,India underwent major revisions to medical device regulations,and announced the Medical Device Rules 2017(Medical Device Rules 2017),which will be implemented from January 2018,with reference to the“Global Harmonization of Medical Device Regulations”(The Global Harmonization Conference).Task Force,referred to as GHTF),divides medical devices into four categories from A to D,corresponding to four risk levels from low risk to high risk.

India's CDSCO also issued the"Classification Standards for Medical Devices and In Vitro Diagnostic Medical Devices"in 2017.India requires that when applying for product registration,the classification decision of the Drug Administration of India(DCGI)for medical devices should be followed.In the case of failure to judge the classification,a classification application should be submitted to CDSCO.

3.Application for medical device manufacturing license for export to India

To export medical devices to India for sale or use,an application for a medical device import license(including grades A to D)must be submitted to CDSCO through an authorised agent in India.CDSCO's review of the medical device import license is mainly divided into two steps:

Step 1:Confirm the compliance of the manufacturer’s Quality Management System(QMS)

First,CDSCO audits the quality management system of the manufacturer submitted by the authorized agent,which must comply with the Indian medical device quality management standard ICMED 13485(modified from ISO 13485,and the Chinese standard YY/T 0287 adopts ISO 13485 equivalently),including:production If the company’s QMS technical documents,inspection reports,and the latest on-site inspection report,etc.,if CDSCO determines that there are doubts about the compliance of the manufacturer’s QMS,it can request evaluation,product testing or on-site inspection of the manufacturer(the cost is borne by the agent).

Step 2:Review the safety and effectiveness of medical devices

If the classification of medical devices exported to India is classified as Class A or Class B,the authorized agent should submit to CDSCO a certificate of free sales in China,or data from clinical testing conducted in China(or other data that can prove the safety and effectiveness of the product).If the classification of the medical device exported to India is C-level or D-level,the authorized agent must perform clinical testing in India.

Exception:If the medical device(level A to D)has been issued a free sale certificate by a regulatory agency in the European Union,the United States,Canada,Japan,or Australia,no further clinical testing is required.

4.Medical device labeling

Articles 44 to 48 of India’s Medical Device Management Regulations 2017 require the labeling of medical devices.

Medical device labeling requirements:Article 44 of the regulations stipulates that the following content should be printed on the shelf packages of medical devices or on the shells of medical devices and on each shell of the packaged medical devices with non-erasable ink.

01.The name of the medical device.

02.The details necessary for the user to identify the device and its use.

03.The name of the manufacturer and the address of the manufacturing site where the device is manufactured.

04.The correct description of the net quantity should be expressed in the metric system in terms of weight,size,volume,unit quantity(depending on the situation)and the quantity of equipment contained in the package.

05.Production year,month and expiry date(or the label should indicate the product's shelf life).

06.Provide instructions when needed to show that the device contains medicinal or biological substances.

07.Provide an obvious batch number and start with the word"Lot No."or"Lot"or"Batch No."or"B.No.".

08.Point out any special storage or handling conditions applicable to the equipment when needed.

09.Indicate whether the device is provided in the form of a sterile product,as well as its sterile state and sterilization method.

10.Give warnings or preventive measures(if deemed relevant)to attract the attention of medical device users.

11.If the equipment is for single use,the equipment should be marked appropriately.

12.If you plan to distribute the medical device as a free sample to medical professionals,overprint the words"Physician’s Sample—Not to be sold"on the label of the device.

13.In addition to imported equipment,add the manufacturing license number before"Manufacturing Licence Number"or"Mfg.Lic.No."or"M.L".

14.If it is imported equipment,provide such details on the label by pasting(if not printed),including:import license number,name and address of the importer,address of the actual production site,and date of manufacture.

15.If a small medical device cannot print all the information clearly due to its size,it should include at least the information required for product identification and safety.For example:the information covered by clauses 1,2,3,and 4 should be included in clauses 5,7,11 and 13.

Unique device identification:Article 46 of the Regulations stipulates that starting from January 1,2022,medical devices approved for manufacture,sale,distribution or import should carry a unique device identification,which should include a device identifier and a production identifier.among them:

01."Device identifier"refers to the global trade item number.

02."Production identifier"refers to the serial number,batch or batch number,medical device software version number,manufacturing date and or expiration date.

3.India's Temporary Policy

The Ministry of Finance of India has issued the 28/2021-Customs Announcement on April 24,2021 to cancel the import tariffs on 18 products including oxygen concentrators(HS 9019/HS 842139)and ventilators(HS 9019)until July 2021 Until the 31st.For details,please refer to the original announcement(see the QR code for the URL link).

The Ministry of Ports,Shipping and Waterways of India also notified major ports on the 25th to cancel port handling fees for imported oxygen and related equipment and give priority to customs clearance for berthing ships.Port officials must strictly control the time for ships to enter the port and customs clearance of goods to assist in logistics operations.