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Pakistan - Healthcare and Medical Equipment

Health care services and medical devices are in high demand in Pakistan, especially in the growing private healthcare market. Healthcare providers include the government, NGOs, and the private sector. The Government of Pakistan (GOP) spent about US$2.15 billion] on health care in the fiscal year ending June 2016, an increase of 13.05 percent over the previous year.

GOP spent US$ 1.39 in 2016-17 (July-March), an increase of 9 percent for the corresponding period in the last year. But private hospitals and clinics are also expanding rapidly, especially in cities, catering to a rapidly growing middle class. According to Business Monitor International, the medical devices market in Pakistan is worth USD 457.1 million and projected to increase to USD 537.5 million by 2020, a CAGR of 6.2 %. U.S. healthcare services and medical equipment are generally well-received in Pakistan, known for high-quality.

Policy for importing international equipment’s

The GOP imposes no restrictions on foreign direct investment in healthcare services, and allows medical equipment imports under its “Open General” regulations. (Imports of radioactive equipment require Pakistan Nuclear Regulatory Authority approval). Import tariffs range from 0 to 25 percent, depending on category. Some medical equipment is exempt from sales taxes. Price, quality and after-sales service support are major factors in medical equipment purchase decisions. A letter of credit is usually the mode of payment for imports. Government tenders can be time-consuming, while decision-making is typically faster in private hospitals.

Regulatory bodies general information

Key regulators in the sector are the Drug Regulatory Authority of Pakistan (DRAP) and the Ministry of National Health Services Regulation and Coordination (MNHSRC). As of 2015, DRAP oversees regulations of medical devices as well. These new regulations include new medical device and in vitro diagnostic (IVD) products, and include requirements for conformity assessments, quality management systems, classification guidelines, authorized representation for foreign manufacturers and related registration steps. The rules cover procedures for registration of medical devices and conformity assessment bodies, licensing of establishments, classification and grouping of devices, post-market surveillance, import and export, labeling requirements, advertisement and ancillary matters. MNHSRC is expected to reduce the costs of certain drugs by 30 percent, however the policy is yet to be implemented.

With the number of hospitals, dispensaries, healthcare units expected to increase owing to the Government of Pakistan’s plans of expanding the Healthcare network, market demand for equipment listed below is expected to grow.

  • Respirators (HS 9019)
  • Monitors, Ventilators
  • Dental Veterinary Instruments and Appliances (HS 9018)
  • Orthopedic Appliances, Hearing Aids (HS 9021)
  • X-Rays, Radiography/ Radio Therapy Apparatus (HS 9022)
  • Second hand and used X-Ray machines, dialysis machine, anesthesia apparatus
  • Health IT/Telemedicine/eHealth
  • Public sector expenditures in health facilities are progressive across the country. The following facilities are expected to grow.

  • General Hospitals
  • Specialized Hospitals
  • Cancer
  • Cardiac
  • Kidney Transplant
  • Liver Transplant
  • Dialysis Centers
  • Chest Diseases
  • E.N.T
  • Neurology
  • Orthopedic
  • Skin Diseases
  • Up gradation / Privatization of Government Hospitals
  • Diagnostics
  • Diagnostic Labs
  • X-Rays & Ultra- Sonography Labs / Clinics
  • Fitness Centers
  • Manufacturing
  • Electro Medical Equipment
  • Auto-disable Syringes/Safety Syringes

  • The impending construction of a number of hospitals in Pakistan will bring opportunities for suppliers of medical devices.

    Competitors include manufacturers from Europe, Japan, South Korea and other countries. In general, china goods and technologies are well regarded and have a reputation for quality and reliability. But local agents note the market is often seeking low cost, and quick decision-making on terms, which can put Chinese companies at a disadvantage. In addition, inconsistent policies and regulations, and political factors, can present market challenges.

    Health care in Pakistan is still in the early stages of development. And a weak health system underlies the poor health status of the population. Government funding on health as a percentage of GDP continues to lag other countries at similar stages of development. Also, moves to decentralize the healthcare system, from federal to provincial governments, have led to wider disparities, with medical device approvals not uniform across the country.

    Other issues include low health manpower levels, a lack of training on the use of medical equipment - much of which is poorly maintained or in disuse - and the underutilization of primary health facilities.

    Business Name 3M Surgicals
    Business Type Health/Medicines
    Products/Services Heart Diseases Procedures
    Contact Person Name Syed Munawar (CEO)
    Telephone No 0515120492, 0515796604
    Email Address 3msurgical@gmail.com
    Website www.3msurgicals.com
    Mailing Address 3RD Floor Khyber Plaza Bank Road Sadder,Rawalpindi Pakistan
    Business Name Advance Business Components
    Business Type Health/Medicines
    Products/Services WHO Approved LLIN Mosquito Nets
    Contact Person Name Asim Ali Khan (Managing Director)
    Telephone No 0915843784, 0915843785
    Email Address asim@abcpvt.com
    Website www.abcpvt.com
    Mailing Address 123 New Spinzer IT Towers University Road Peshawar KPK Pakistan,Peshawar Pakistan
    Business Name Al-Jadeed Enterprises
    Business Type Health/Medicines
    Products/Services Laboratory Wares, Glass Ware, Chemicals, Chemistry kits,
    Elisa kits, Rapid Test Devices and General Order Supplier
    Contact Person Name Yasir Siddiq Mughal (CEO)
    Telephone No 0333-5108678, 0333-5108678
    Email Address aljadeedenterprises@yahoo.com, aljadeed786@gmail.com
    Website www.ajms.biz
    Mailing Address Office # 2, 2nd floor 3212 cantonment road saddar Rawalpindi Pakistan
    Business Name Ambro Pharmaceuticals
    Business Type Health/Medicines
    Products/Services Medicine,Clinical Laboratory Items, Diagnostic Reagent Kits, Equipments,
    Blood GP Reagents & Accessories,Culture Media, Medical & Surgical Disposables
    Contact Person Name Zeeshan Majeed Ch (CEO)
    Telephone No 0515131273
    Email Address chaudharyzeeshan1@gmail.com
    Website www.ajms.biz
    Mailing Address J-303, Unisco Place First Floor, Murree Road, Rawalpindi Pakistan
    Business Name Apical Ways (Pvt) Limited
    Business Type Health/Medicines
    Products/Services Bio-Medical Equipment and General Order Supplies
    Contact Person Name Mirza Nadeem Hafeez (Director)
    Telephone No 0092512255052, 0092512255892
    Email Address info@monitorassociate.com, coo@monitorassociate.com
    Website www.apicalways.com
    Mailing Address House No.10-B,St 26 Sector F-8/1, Park Road,Islamabad Pakistan
    Business Name Arshman Medical Traders
    Business Type Health/Medicines
    Products/Services Supplier of Medical Equipment
    Contact Person Name Imran Naveed (Director)
    Telephone No 03138448012, 03335008529
    Email Address arshmanraza@gmail.com, imran_naveed@hotmail.com
    Website
    Mailing Address Arshman Medical Traders, Main Plaza Basement, Office No.26,
    G1 Near Doctor Hospital, Johar Town, Lahore Pakistan
    Business Name Azam Trading Services
    Business Type Health/Medicines
    Products/Services Medical Equipment & Healthcare
    Contact Person Name Tariq Azam (CEO)
    Telephone No 0092-51-2113160, 0092-51-2113161
    Email Address azamtrading@hotmail.com, azamtrading@gmail.com
    Website www.azamtradig786.com
    Mailing Address House.No.344-E, Street No.72, Sector G-11/2, Islamabad, Pakistan
    Business Name Base Global Instruments
    Business Type Health/Medicines
    Products/Services Surgical appliances/ instruments
    Contact Person Name Muhammad Ahsan (Execustive Corespondence )
    Telephone No 0092-333-2221008
    Email Address sales@bginst.com, info@bginst.com
    Website www.bginst.com
    Mailing Address Industrial Area,MuzaffarPur,Sialkot, Pakistan
    Business Name Bestech Enterprises
    Business Type Health/Medicines
    Products/Services Medical Equipment Sale and Service
    Contact Person Name Naseer Ahmad (Director)
    Telephone No 041-2412082
    Email Address bestech.enterprises@gmail.com
    Website
    Mailing Address Naseem Hights Plaza Chiniout bazar, Faisalabad, Pakistan
    Business Name Bhs Pharma
    Business Type Health / Medicines
    Products/Services Surgical Instruments / Medicines / Health Related Items
    Contact Person Name Muhammad Bilal Shahid (Owner)
    Telephone No 0092 300 8363366,
    Email Address bhspharma@hotmail.com
    Website bhs-pharma.pakbd.com
    Mailing Address B1-15, Kuri Road, Sadiqabad, Rawalpindi, Pakistan
    Business Name Burraq International
    Business Type Health/Medicines
    Products/Services Surgical Medical Disposable / Equipment’s
    Contact Person Name Qaiser Mehmood (Manager)
    Telephone No 0092 42 36186290
    Email Address info@burraqinternational.com, mehmood@burraqinternational.com
    Website www.burraqinternational.com
    Mailing Address 242-A/III PGECHS College Road Lahore, Pakistan
    Business Name Cabbot Surgicals
    Business Type Health/Medicines
    Products/Services Medical Equipment, Cosumables
    Contact Person Name Muhammad Atique Shahid (Director)
    Telephone No 00923215349126, 0514320578
    Email Address cabbot.surgicals@gmail.com, atiq_shahid@hotmail.com
    Website www.cabbot.com
    Mailing Address E-226 5th Road satellite town Rawalpindi,Rawalpindi Pakistan
    Business Name CCP Instruments
    Business Type Health/Medicines
    Products/Services Medical Equipments
    Contact Person Name Muhammad Abid Chaudhary (CEO)
    Telephone No 0092 321 9445989
    Email Address ccp.instruments@yahoo.com, chaudhary.abid@gmail.com
    Website
    Mailing Address 20-Abbass block,Mustafa town,Lahore Pakistan
    Business Name Chem Tech
    Business Type Health/Medicines
    Products/Services Laboratory Chemicals, Equipments, Glass and Plastic ware,Raw Materials
    Contact Person Name Munir Rahim (Director)
    Telephone No 00923225110771, 00923333238888
    Email Address biz.arco@yahoo.com, shabbir_awan@hotmail.com
    Website chemtechs.webs.com
    Mailing Address Millan Market, Office No. 5, Chirah Road, Near Mughal Plaza, Sadiqabad, Rawalpindi Pakistan
    Business Name Credible Enterprises
    Business Type Health/Medicines
    Products/Services Medicines, Surgical Disposals
    Contact Person Name Syed Adnan Qamar (Managing Partner)
    Telephone No 0092 051 5519887, 0092 051 5516892
    Email Address credibleent@dsl.net.pk, qamar1951@gmail.com
    Website
    Mailing Address 3-B, Pine Complex, Iftikhar Janjua Road, Rawalpindi Cantt-46000. Pakistan
    Business Name Creek Pharmaceuticals
    Business Type Health/Medicines
    Products/Services Medicines/equipmenets
    Contact Person Name Daniyal (MD)
    Telephone No 0092 21 35869488, 0092 21 35869488
    Email Address creekpharmaceutical@hotmail.com, daniyalsiyal@hotmail.com
    Website
    Mailing Address Office#13-c Mashallah Massoinate Behind bank Al.Habib Zamzama Phase 5 Karachi, Pakistan
    Business Name Flowtronix Systems
    Business Type Health/Medicines
    Products/Services Surgical/Disposable Items
    Contact Person Name Muhammad Shahzad Akram (Proprietor)
    Telephone No 0092 51 4346466
    Email Address flowtronixsystems@hotmail.com, s_acp@hotmail.com
    Website
    Mailing Address Flat 4,2nd Floor Al-Ashraf Plaza Range Road,Rawalpindi Pakistan
    Business Name First Global Link,LLC
    Business Type Health/Medicines
    Products/Services Electromedical Equipments
    Contact Person Name Sohail Bhatti (General Manager)
    Telephone No 0002 42 37514733, 0092 42 37514733
    Email Address sabhatti@firstglink.com, sohail.aslam2001@gmail.com
    Website www.firstglink.com
    Mailing Address 238-Eden Canal Villas, Canal Bank Road. Thokar Niaz Baig.,Lahore Pakistan

    Revenue Split

    Sectors

  • Orthopedic Implants & Prosthetics
  • Cardiovascular
  • Neurovascular
  • Dental
  • life Science Tools & Service
  • Patient Monitoring Equipment & Therapies
  • Disposable Equipment & Supplies
  • General Equipment & Supplies
  • In Vitro Diagnostics, Supplies & Equipment
  • Global Medical Device Market

    Top medical device producer world wide

    Major Player

    S.W.O.T Analysis

    Conclusion

    Medical Technology companies are accelerating their Investments in emerging markets and Pakistan is a prime target because of its growing population, growing middle class and improving healthcare infrastructure Till date most Med Tech multinationals have pursued a conservative business strategy and operating model in Pakistan focused on delivering their existing offering to the premium segment of the market.
    But now the playing field is becoming more competitive and companies in search of growth need to move beyond the traditional model.

    Application Procedure for Medical Devices Registration

    1. An application shall be made by
      • An establishment having valid license to manufacture
      • An importer having valid establishment license
    2. On the format as set out in Form-6 or Form-6A
    3. An application shall be accompanied by
      • Application fee
      • Information or documents or samples
    4. The MDB may reject an application, if the applicant fails to Deposit fee or provide information
    5. The manufacturing methods and testing procedures shall Conform to the principles of validation.
    6. Complete labeling and prescribing information shall be same As approved in the country of origin or as approved in European Union, USA, Japan, Canada or Australia.
    7. Upon receipt of the application form
      • The MDB may inspect the premises If the MDB is satisfied it shall register the medical device and Enter it in the medical device register.
      • The registration shall be for a period of five years
      • Certificate of registration on Form-7 or Form-7A

    Renewal of registration of medical device

    1. Renewal on Form-6 or Form-6A sixty days before its expiry And shall be accompanied by
      • application fee
      • Information or documents or samples,
    2. The MDB may inspect the premises If the MDB is satisfied it shall renew the registration for a period of five years from the date of expiry of previous certificate
    3. If renewal is made after validity but within sixty days, the Applicant shall pay an additional surcharge of ten percent of the Renewal fee for registration for each day the application is delayed.
    4. If an application for renewal is made after sixty days of expiry of the period of validity, the application shall be treated as a fresh Application for grant of registration
    5. The registration shall continue to be valid until orders are Passed on such application if applied before the expiry or within sixty days after expiry.
    6. If an application for renewal is made after sixty days of expiry, the establishment shall be responsible for all the illegal operations
    7. In case the application for renewal is rejected the MDB, it shall inform the applicant of its decision in writing with reasons of such decision

    Changes concerning registered medical device

    1. An application for change on Form-6 or Form-6A and shall be accompanied by fee
    2. The MDB may inspect the premises
    3. ) If any contravenes its registration may be cancelled or suspended as the MDB may deem fit after giving to the registration holder the opportunity of being heard

    Conditions of registration of medical device

    1. A registration holder shall comply with the conditions of rules
    2. The indications, contra-indications, side effects, precautions, warnings, directions for use etc. shall be clearly specified in the labeling and promotion
    3. Each medical device shall be produced in sufficient quantity
    4. The manufacture or import of any medical device shall not, without the prior approval of the MDB, be discontinued
    5. The importer shall ensure regular and adequate supply of the medical device in Pakistan
    6. The registration holder or his authorized agent shall for any medical device sold by him issue a warranty thereof on the format as set out in Form-5
    7. In respect of new medical device full information regarding following record shall be maintained
      • Clinical investigations and tests conducted by the manufacturer or reported to him by any person concerning that medical device
      • Reports from the scientific literature or the bibliography there from that are available to him concerning that medical device
      • Experiences, investigations, studies and tests involving the physical or chemical properties or any other properties of that medical device
      • Any error in the labeling of that medical device
      • Any bacteriological or any significant chemical or physical or other change or deterioration in any batch or lot of that medical device
      • Any failure of one or more distributed batches
      • Any unexpected side effects, injury, toxicity or sensitivity reaction associated with the clinical uses, studies, investigations and tests respecting that medical device
      • Any unusual failure
    8. The following information shall be supplied to the MDB
      • Report in duplicate of all records respecting the information contemplated by clauses
      • as soon as possible and in any event within fourteen days, reports in duplicate of all records respecting the information contemplated by clauses
    9. If a medical device, at any time, is withdrawn or banned or certain restrictions are imposed in any of the countries, namely, USA, European Union countries, Canada, Japan or Australia, then it shall be the responsibility of the manufacturer in Pakistan or, as the case may be, the importer, to immediately withdraw the medical device from the market in Pakistan or to impose similar restriction and to inform the MDB within fourteen days
    10. If a clinical information for a medical device is approved by a regulatory authority in any of the said countries, the same clinical information shall be considered as approved for medical device registration in Pakistan unless modified by the MDB on the basis of scientific data
    11. If any adverse reaction of medical device, is reported in any of the said countries, it shall be the responsibility of the concerned manufacturer or the importer to report it to the MDB within thirty days.
    12. The manufacturer orthe importer shall supply the information in relation to safety, performance, production, quality or availability of the medical device as and when required by the MDB
    13. If a person contravenes these rules, he shall after being heard be liable for suspension or cancellation of his registration
    14. On the basis of information received or an inquiry conducted is of opinion that
      • The registration of a medical device was procured by fraud or misrepresentation
      • The circumstances in which a medical device was registered no longer exist
      • It is necessary in the public interest so to do, the MDB may, after affording to the registration holder an opportunity of showing cause against the action proposed to be taken, cancel or suspend the registration

    Cancellation or suspension of registration of medical device

    1. Before cancellation or suspension the MDB shall issue a show cause notice
    2. The establishment shall submit, reply to the show cause notice within fifteen days
    3. The MDB, after being satisfied that the establishment has not complied with the conditions of registration or contravened the provision of the DRAP Act may cancel or for a specified period suspend the registration
    4. The MDB shall inform the establishment, in writing, on the cancellation or suspension of the registration
    5. Where a registration is cancelled by the MDB the establishment shall within fourteen days after being informed in writing of the cancellation return the certificate of registration to the MDB without demand

    Important government websites

    Healthcare Procurement
    Government Health Plans
    Ministry of National Health Services, Regulations & Coordination
    Drug Regulation Authority of Pakistan
    E-Health Association of Pakistan
    Pakistan medical and dental council